- Oncolytics Biotech Scientific Advisory Board Member, Dr. Alan J. Tuchman, appointed Board Director for Duska Therapeutics, Inc. See article here.
- Oncolytics Biotech Inc. insiders buy shares. See article here.
Wednesday, October 31, 2007
News Round Up
Tuesday, October 30, 2007
Oncolytics Biotech Inc. Announces 2007 Third Quarter Results
Edited. Read the complete report here.
CALGARY, AB, --- October 30, 2007
Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) today announced its financial results and highlights for the three and nine-month periods ended September 30, 2007.
Third Quarter Highlights
• Announced positive interim results from a U.K. Phase Ia/1b combination REOLYSIN® and radiation trial for patients with advanced cancers - including partial and remote responses in patients with a variety of advanced cancers;
• Commenced patient enrolment in a multi-centre, combination REOLYSIN® and docetaxel Taxotere®) systemic administration trial in the U.K.;
• In October, received approval from the U.K. regulatory authorities to begin a combination REOLYSIN® and cyclophosphamide trial for patients with advanced cancers;
• Secured two additional U.S. patents, for a total of more than 150 issuedpatents worldwide; and,
• Presented preclinical work at the National Cancer Research Institute Conference in Birmingham, U.K. demonstrating for the first time how reovirus-infected melanoma cells stimulate dendritic cells to prime the immune system against cancer cells.
“With positive results being reported from our clinical trial program in the U.K. and the U.S., seven trials actively enrolling, an additional combination trial approved to begin and an expanding intellectual property portfolio supporting our technology, Oncolytics is looking forward to making substantial progress through the balance of 2007 and 2008,” said Dr. Brad Thompson, President and CEO of Oncolytics.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
This discussion and analysis should be read in conjunction with the unaudited financial statements of Oncolytics Biotech Inc. as at and for the three and nine months ended September 30, 2007 and 2006, and should also be read in conjunction with the audited financial statements and Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) contained in our annual report for the year ended December 31, 2006. The financial statements have been prepared in accordance with Canadian generally accepted accounting principles (“GAAP”).
FORWARD-LOOKING STATEMENTS
The following discussion contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including our belief as to the potential of REOLYSIN® as a cancer therapeutic and our expectations as to the success of our research and development and manufacturing programs in 2007 and beyond, future financial position, business strategy and plans for future operations, and statements that are not historical facts, involve known and unknown risks and uncertainties, which could cause our actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the need for and availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, our ability to successfully commercialize REOLYSIN®, uncertainties related to the research, development and manufacturing of pharmaceuticals, uncertainties related to competition, changes in technology, the regulatory process and general changes to the economic environment. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Forward-looking statements are based on assumptions, projections, estimates and expectations of management at the time such forward-looking statements are made, and such assumptions, projections, estimates and/or expectations could change or prove to be incorrect or inaccurate. Investors are cautioned against placing undue reliance on forward-looking statements. We do not undertake to update these forward-looking statements.
OVERVIEW
Oncolytics Biotech Inc. is a Development Stage Company
Since our inception in April of 1998, Oncolytics Biotech Inc. has been a development stage company and we have focused our research and development efforts on the development of REOLYSIN®, our potential cancer therapeutic. We have not been profitable since our inception and expect to continue to incur substantial losses as we continue research and development efforts. We do not expect to generate significant revenues until, if and when, our cancer product becomes commercially viable.
General Risk Factors
Prospects for biotechnology companies in the research and development stage should generally be regarded as speculative. It is not possible to predict, based upon studies in animals, or early studies in humans, whether a new therapeutic will ultimately prove to be safe and effective in humans, or whether necessary and sufficient data can be developed through the clinical trial process to support a successful product application and approval.
If a product is approved for sale, product manufacturing at a commercial scale and significant sales to end users at a commercially reasonable price may not be successful. There can be no assurance that we will generate adequate funds to continue development, or will ever achieve significant revenues or profitable operations. Many factors (e.g. competition, patent protection, appropriate regulatory approvals) can influence the revenue and product profitability potential.
In developing a pharmaceutical product, we rely upon our employees, contractors, consultants and collaborators and other third party relationships, including our ability to obtain appropriate product liability insurance. There can be no assurance that these reliances and relationships will continue as required.
In addition to developmental and operational considerations, market prices for securities of biotechnology companies generally are volatile, and may or may not move in a manner consistent with the progress being made by Oncolytics.
See also “RISK FACTORS AFFECTING FUTURE PERFORMANCE” in our 2006 MD&A.
REOLYSIN® Development Update for the Third Quarter of 2007
We continue to develop our lead product REOLYSIN® as a possible cancer therapy. Our goal each year is to advance REOLYSIN® through the various steps and stages of development required for potential pharmaceutical products. In order to achieve this goal, we actively manage the development of our clinical trial program, our pre-clinical and collaborative programs, our manufacturing process and REOLYSIN® supply, and our intellectual property.
Clinical Trial Program
Our clinical trial program includes eight clinical trials of which seven are being conducted by us and one is being sponsored by the U.S. National Cancer Institute (“NCI”). In the third quarter of 2007, we announced positive interim results from our U.K. Phase Ia/Ib combination REOLYSIN® and radiation clinical trial. As well, we commenced patient enrollment in our U.K.
combination REOLYSIN®/docetaxel clinical trial, increasing our actively enrolling clinical trials to seven.
Clinical Trial Results
In the third quarter of 2007, we announced positive interim results from our U.K. Phase Ia/Ib combination REOLYSIN® and radiation clinical trial for patients with advanced or metastatic cancers. As of September 28, 2007, 22 patients had been treated with 15 having completed the study. Five patients withdrew from the study, and two patients are still on study.
A total of 11 patients in the Ia portion of the trial have received two intratumoural treatments of REOLYSIN® at dosages of 1x108, 1x109, or 1x1010 TCID50 with a constant localized radiation dose of 20 Gy given in five fractions. Of these 11 patients, three patients (oesophageal, squamous skin carcinoma and squamous cell scalp) experienced significant partial responses.
One month following treatment, the oesophageal patient experienced a 28.5% reduction in the target tumour, with stable disease noted in four, non-treated tumours. At two and three months, the target tumour had shrunk 64%, with stable disease continuing
in the four non-treated tumours, including a 15% volume reduction in non-treated mediastinal disease that was maintained for more than six months. The squamous skin cancer patient experienced a 50% reduction in the target tumour, as well as stable disease in two, non-treated tumours at one, two and three months post treatment. The squamous cell scalp patient experienced stable disease in the target tumour for two months which then became a partial response at three months. This patient also experienced stable disease in one non-treated tumour measured at three months post-treatment.
Patients in the Ib portion received either two, four or six intratumoural doses of REOLYSIN® at 1x1010 TCID50 with a constant localized radiation dose of 36 Gy given in 12 fractions. Of the six patients who have completed the study to date, three patients (colorectal, melanoma and lung cancer) experienced tumour regression in the target tumour, as well as stable disease in nontreated tumours.
The colorectal patient experienced a partial response with a more than 50% regression in the target tumour as well as stable disease in four, non-treated tumours measured at one month following treatment. A melanoma patient experienced minor regression in the target tumour as well as stable disease in two, non-treated tumours at one and two months following treatment.
A lung cancer patient experienced minor regression in the target tumour, as well as stable disease in three, non-treated tumours at two months following treatment.
The treatment has been well tolerated, with mostly Grade 1 or 2 toxicities noted including fatigue, lymphopenia, fever, and neutropenia. Grade 3 toxicities including cellulitis, dysphasia and diarrhoea were related to disease progression and not to the combination treatment. Viral replication was unaffected by cellular irradiation.
The primary objective of the Phase Ia/Ib trial was to determine the maximum tolerated dose (“MTD”), dose limiting toxicity (“DLT”), and safety profile of REOLYSIN® when administered intratumourally to patients receiving radiation treatment. A secondary objective is to examine any evidence of anti-tumour activity. Eligible patients include those who have been diagnosed with late stage advanced or metastatic solid tumours that are refractory (“have not responded”) to standard therapy or for which no curative standard therapy exists.
Clinical Trials – Actively Enrolling
At the end of the third quarter of 2007, we were actively enrolling in seven clinical trials. In the third quarter of 2007, we commenced enrollment in the following study:
U.K. Combination REOLYSIN® Docetaxel Clinical Trial
We commenced patient enrolment in our U.K. clinical trial to evaluate the anti-tumour effects of systemic administration of REOLYSIN® in combination with docetaxel (Taxotere®) in patients with advanced cancers including bladder, prostate, lung and upper gastro-intestinal. In preclinical studies, the combination of REOLYSIN® and various taxanes including docetaxel has
been shown to be synergistic against a variety of cancer cell lines.
The trial has two components. The first is an open-label, dose-escalating, non-randomized study of REOLYSIN® given intravenously with docetaxel every three weeks. A standard dosage of docetaxel will be delivered with escalating dosages of REOLYSIN® intravenously. A maximum of three cohorts will be enrolled in the REOLYSIN® dose escalation portion. The second component of the trial will immediately follow and will include the enrolment of a further 12 patients at the maximum dosage of REOLYSIN® in combination with a standard dosage of docetaxel.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours such as bladder, prostate, lung or upper gastro-intestinal cancers that are refractory to standard therapy or for which no curative standard therapy exists. The primary objective of the trial is to determine the MTD, DLT, recommended dose and dosing schedule and safety profile of REOLYSIN® when administered in combination with docetaxel. Secondary objectives include the evaluation of immune response to the drug combination, the body’s response to the drug combination compared to chemotherapy alone and any evidence of anti-tumour activity.
Pre-Clinical Trial and Collaborative Program
In the third quarter of 2007, we announced that a poster presentation entitled “Reovirus Infection of Human Melanoma Cells Supports Priming of Anti-Tumour Cytotoxic T Cell Immunity” was presented by Dr. Robin Prestwich of CR-UK Clinical Centre, Leeds Institute of Molecular Medicine, University of Leeds, U.K at the National Cancer Research Institute Cancer
Conference in Birmingham, U.K.
In this study, the investigators infected melanoma cell lines with reovirus. The reovirus-infected cell lines stimulated the maturation of dendritic cells, which in turn educated cancer-killing T cells to attack and kill the melanoma cells.
Manufacturing and Process Development
We continued to have REOLYSIN® manufactured in order to supply our current and future clinical trial program. In the third quarter of 2007, our manufacturing activity was focused on the completion of the vial filling and packaging of the production runs that were completed earlier in 2007. Also in the third quarter of 2007, we continued process development that examined the scale up of our manufacturing process increasing the batch size from our present GMP scale of 20-litres to 40-litres and then to 100-litres.
Intellectual Property
In the third quarter of 2007, two U.S. patents were issued. At the end of the third quarter of 2007, we had been issued over 150 patents including 23 U.S. and six Canadian patents as well as issuances in other jurisdictions. We also have over 180 patent applications filed in the U.S., Canada and other jurisdictions.
Financial Impact
We estimated at the beginning of 2007 that our monthly cash usage would be approximately $1,400,000 for 2007. Our cash usage for the nine months ending September 30, 2007 was $10,849,863 from operating activities and $635,815 for the purchases of intellectual property and capital assets which is in line with our estimate. Our net loss for the nine month period ending September 30, 2007 was $11,556,714.
Cash Resources
We exited the third quarter of 2007 with cash resources totaling $28,191,464 (see “Liquidity and Capital Resources”).
Expected REOLYSIN® Development for the Remainder of 2007
We plan to continue to enroll patients in our seven clinical trials and expect to add an additional clinical co-therapy trial. We believe that the NCI sponsored melanoma clinical trial will receive approval to commence in 2007. We believe we will complete enrollment in our U.K. Phase Ia/Ib clinical trial by the end of 2007 and complete enrollment in our Phase II combination REOLYSIN®/radiation and chemotherapy co-therapy studies in 2008. Also, our process development activity will focus on scale up studies and the examination of a lyophilization process for REOLYSIN®.
Based on our expected activity in 2007, we continue to estimate our average monthly cash usage to be $1,400,000 per month (see “Liquidity and Capital Resources”).
Recent 2007 Progress
On October 23, 2007, we announced receipt of a letter of approval to commence our clinical trial using intravenous administration of REOLYSIN® in combination with cyclophosphamide, a chemotherapeutic agent as well as immune modulator, in patients with advanced cancers.
The trial is an open-label, dose-escalating, non-randomized trial of REOLYSIN® given intravenously with escalating doses of cyclophosphamide. A standard dose of REOLYSIN® is administered intravenously over five consecutive days, while an intravenous dose of cyclophosphamide is administered three days before REOLYSIN® treatment and continues through the course of the treatment cycle. The total number of patients studied will depend on the number of dose levels tested, but it is anticipated to be approximately 30 patients.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours including pancreatic, lung and ovarian cancers that are refractory to standard therapy or for which no curative standard therapy exists. The primary objectives of the trial include determining the Minimum Effective Immunomodulatory Dose of cyclophosphamide to obtain successful immune modulation. Secondary objectives include the safety profile of the combination and gathering any evidence of anti-tumour activity.
CALGARY, AB, --- October 30, 2007
Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) today announced its financial results and highlights for the three and nine-month periods ended September 30, 2007.
Third Quarter Highlights
• Announced positive interim results from a U.K. Phase Ia/1b combination REOLYSIN® and radiation trial for patients with advanced cancers - including partial and remote responses in patients with a variety of advanced cancers;
• Commenced patient enrolment in a multi-centre, combination REOLYSIN® and docetaxel Taxotere®) systemic administration trial in the U.K.;
• In October, received approval from the U.K. regulatory authorities to begin a combination REOLYSIN® and cyclophosphamide trial for patients with advanced cancers;
• Secured two additional U.S. patents, for a total of more than 150 issuedpatents worldwide; and,
• Presented preclinical work at the National Cancer Research Institute Conference in Birmingham, U.K. demonstrating for the first time how reovirus-infected melanoma cells stimulate dendritic cells to prime the immune system against cancer cells.
“With positive results being reported from our clinical trial program in the U.K. and the U.S., seven trials actively enrolling, an additional combination trial approved to begin and an expanding intellectual property portfolio supporting our technology, Oncolytics is looking forward to making substantial progress through the balance of 2007 and 2008,” said Dr. Brad Thompson, President and CEO of Oncolytics.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
This discussion and analysis should be read in conjunction with the unaudited financial statements of Oncolytics Biotech Inc. as at and for the three and nine months ended September 30, 2007 and 2006, and should also be read in conjunction with the audited financial statements and Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) contained in our annual report for the year ended December 31, 2006. The financial statements have been prepared in accordance with Canadian generally accepted accounting principles (“GAAP”).
FORWARD-LOOKING STATEMENTS
The following discussion contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including our belief as to the potential of REOLYSIN® as a cancer therapeutic and our expectations as to the success of our research and development and manufacturing programs in 2007 and beyond, future financial position, business strategy and plans for future operations, and statements that are not historical facts, involve known and unknown risks and uncertainties, which could cause our actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the need for and availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, our ability to successfully commercialize REOLYSIN®, uncertainties related to the research, development and manufacturing of pharmaceuticals, uncertainties related to competition, changes in technology, the regulatory process and general changes to the economic environment. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Forward-looking statements are based on assumptions, projections, estimates and expectations of management at the time such forward-looking statements are made, and such assumptions, projections, estimates and/or expectations could change or prove to be incorrect or inaccurate. Investors are cautioned against placing undue reliance on forward-looking statements. We do not undertake to update these forward-looking statements.
OVERVIEW
Oncolytics Biotech Inc. is a Development Stage Company
Since our inception in April of 1998, Oncolytics Biotech Inc. has been a development stage company and we have focused our research and development efforts on the development of REOLYSIN®, our potential cancer therapeutic. We have not been profitable since our inception and expect to continue to incur substantial losses as we continue research and development efforts. We do not expect to generate significant revenues until, if and when, our cancer product becomes commercially viable.
General Risk Factors
Prospects for biotechnology companies in the research and development stage should generally be regarded as speculative. It is not possible to predict, based upon studies in animals, or early studies in humans, whether a new therapeutic will ultimately prove to be safe and effective in humans, or whether necessary and sufficient data can be developed through the clinical trial process to support a successful product application and approval.
If a product is approved for sale, product manufacturing at a commercial scale and significant sales to end users at a commercially reasonable price may not be successful. There can be no assurance that we will generate adequate funds to continue development, or will ever achieve significant revenues or profitable operations. Many factors (e.g. competition, patent protection, appropriate regulatory approvals) can influence the revenue and product profitability potential.
In developing a pharmaceutical product, we rely upon our employees, contractors, consultants and collaborators and other third party relationships, including our ability to obtain appropriate product liability insurance. There can be no assurance that these reliances and relationships will continue as required.
In addition to developmental and operational considerations, market prices for securities of biotechnology companies generally are volatile, and may or may not move in a manner consistent with the progress being made by Oncolytics.
See also “RISK FACTORS AFFECTING FUTURE PERFORMANCE” in our 2006 MD&A.
REOLYSIN® Development Update for the Third Quarter of 2007
We continue to develop our lead product REOLYSIN® as a possible cancer therapy. Our goal each year is to advance REOLYSIN® through the various steps and stages of development required for potential pharmaceutical products. In order to achieve this goal, we actively manage the development of our clinical trial program, our pre-clinical and collaborative programs, our manufacturing process and REOLYSIN® supply, and our intellectual property.
Clinical Trial Program
Our clinical trial program includes eight clinical trials of which seven are being conducted by us and one is being sponsored by the U.S. National Cancer Institute (“NCI”). In the third quarter of 2007, we announced positive interim results from our U.K. Phase Ia/Ib combination REOLYSIN® and radiation clinical trial. As well, we commenced patient enrollment in our U.K.
combination REOLYSIN®/docetaxel clinical trial, increasing our actively enrolling clinical trials to seven.
Clinical Trial Results
In the third quarter of 2007, we announced positive interim results from our U.K. Phase Ia/Ib combination REOLYSIN® and radiation clinical trial for patients with advanced or metastatic cancers. As of September 28, 2007, 22 patients had been treated with 15 having completed the study. Five patients withdrew from the study, and two patients are still on study.
A total of 11 patients in the Ia portion of the trial have received two intratumoural treatments of REOLYSIN® at dosages of 1x108, 1x109, or 1x1010 TCID50 with a constant localized radiation dose of 20 Gy given in five fractions. Of these 11 patients, three patients (oesophageal, squamous skin carcinoma and squamous cell scalp) experienced significant partial responses.
One month following treatment, the oesophageal patient experienced a 28.5% reduction in the target tumour, with stable disease noted in four, non-treated tumours. At two and three months, the target tumour had shrunk 64%, with stable disease continuing
in the four non-treated tumours, including a 15% volume reduction in non-treated mediastinal disease that was maintained for more than six months. The squamous skin cancer patient experienced a 50% reduction in the target tumour, as well as stable disease in two, non-treated tumours at one, two and three months post treatment. The squamous cell scalp patient experienced stable disease in the target tumour for two months which then became a partial response at three months. This patient also experienced stable disease in one non-treated tumour measured at three months post-treatment.
Patients in the Ib portion received either two, four or six intratumoural doses of REOLYSIN® at 1x1010 TCID50 with a constant localized radiation dose of 36 Gy given in 12 fractions. Of the six patients who have completed the study to date, three patients (colorectal, melanoma and lung cancer) experienced tumour regression in the target tumour, as well as stable disease in nontreated tumours.
The colorectal patient experienced a partial response with a more than 50% regression in the target tumour as well as stable disease in four, non-treated tumours measured at one month following treatment. A melanoma patient experienced minor regression in the target tumour as well as stable disease in two, non-treated tumours at one and two months following treatment.
A lung cancer patient experienced minor regression in the target tumour, as well as stable disease in three, non-treated tumours at two months following treatment.
The treatment has been well tolerated, with mostly Grade 1 or 2 toxicities noted including fatigue, lymphopenia, fever, and neutropenia. Grade 3 toxicities including cellulitis, dysphasia and diarrhoea were related to disease progression and not to the combination treatment. Viral replication was unaffected by cellular irradiation.
The primary objective of the Phase Ia/Ib trial was to determine the maximum tolerated dose (“MTD”), dose limiting toxicity (“DLT”), and safety profile of REOLYSIN® when administered intratumourally to patients receiving radiation treatment. A secondary objective is to examine any evidence of anti-tumour activity. Eligible patients include those who have been diagnosed with late stage advanced or metastatic solid tumours that are refractory (“have not responded”) to standard therapy or for which no curative standard therapy exists.
Clinical Trials – Actively Enrolling
At the end of the third quarter of 2007, we were actively enrolling in seven clinical trials. In the third quarter of 2007, we commenced enrollment in the following study:
U.K. Combination REOLYSIN® Docetaxel Clinical Trial
We commenced patient enrolment in our U.K. clinical trial to evaluate the anti-tumour effects of systemic administration of REOLYSIN® in combination with docetaxel (Taxotere®) in patients with advanced cancers including bladder, prostate, lung and upper gastro-intestinal. In preclinical studies, the combination of REOLYSIN® and various taxanes including docetaxel has
been shown to be synergistic against a variety of cancer cell lines.
The trial has two components. The first is an open-label, dose-escalating, non-randomized study of REOLYSIN® given intravenously with docetaxel every three weeks. A standard dosage of docetaxel will be delivered with escalating dosages of REOLYSIN® intravenously. A maximum of three cohorts will be enrolled in the REOLYSIN® dose escalation portion. The second component of the trial will immediately follow and will include the enrolment of a further 12 patients at the maximum dosage of REOLYSIN® in combination with a standard dosage of docetaxel.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours such as bladder, prostate, lung or upper gastro-intestinal cancers that are refractory to standard therapy or for which no curative standard therapy exists. The primary objective of the trial is to determine the MTD, DLT, recommended dose and dosing schedule and safety profile of REOLYSIN® when administered in combination with docetaxel. Secondary objectives include the evaluation of immune response to the drug combination, the body’s response to the drug combination compared to chemotherapy alone and any evidence of anti-tumour activity.
Pre-Clinical Trial and Collaborative Program
In the third quarter of 2007, we announced that a poster presentation entitled “Reovirus Infection of Human Melanoma Cells Supports Priming of Anti-Tumour Cytotoxic T Cell Immunity” was presented by Dr. Robin Prestwich of CR-UK Clinical Centre, Leeds Institute of Molecular Medicine, University of Leeds, U.K at the National Cancer Research Institute Cancer
Conference in Birmingham, U.K.
In this study, the investigators infected melanoma cell lines with reovirus. The reovirus-infected cell lines stimulated the maturation of dendritic cells, which in turn educated cancer-killing T cells to attack and kill the melanoma cells.
Manufacturing and Process Development
We continued to have REOLYSIN® manufactured in order to supply our current and future clinical trial program. In the third quarter of 2007, our manufacturing activity was focused on the completion of the vial filling and packaging of the production runs that were completed earlier in 2007. Also in the third quarter of 2007, we continued process development that examined the scale up of our manufacturing process increasing the batch size from our present GMP scale of 20-litres to 40-litres and then to 100-litres.
Intellectual Property
In the third quarter of 2007, two U.S. patents were issued. At the end of the third quarter of 2007, we had been issued over 150 patents including 23 U.S. and six Canadian patents as well as issuances in other jurisdictions. We also have over 180 patent applications filed in the U.S., Canada and other jurisdictions.
Financial Impact
We estimated at the beginning of 2007 that our monthly cash usage would be approximately $1,400,000 for 2007. Our cash usage for the nine months ending September 30, 2007 was $10,849,863 from operating activities and $635,815 for the purchases of intellectual property and capital assets which is in line with our estimate. Our net loss for the nine month period ending September 30, 2007 was $11,556,714.
Cash Resources
We exited the third quarter of 2007 with cash resources totaling $28,191,464 (see “Liquidity and Capital Resources”).
Expected REOLYSIN® Development for the Remainder of 2007
We plan to continue to enroll patients in our seven clinical trials and expect to add an additional clinical co-therapy trial. We believe that the NCI sponsored melanoma clinical trial will receive approval to commence in 2007. We believe we will complete enrollment in our U.K. Phase Ia/Ib clinical trial by the end of 2007 and complete enrollment in our Phase II combination REOLYSIN®/radiation and chemotherapy co-therapy studies in 2008. Also, our process development activity will focus on scale up studies and the examination of a lyophilization process for REOLYSIN®.
Based on our expected activity in 2007, we continue to estimate our average monthly cash usage to be $1,400,000 per month (see “Liquidity and Capital Resources”).
Recent 2007 Progress
On October 23, 2007, we announced receipt of a letter of approval to commence our clinical trial using intravenous administration of REOLYSIN® in combination with cyclophosphamide, a chemotherapeutic agent as well as immune modulator, in patients with advanced cancers.
The trial is an open-label, dose-escalating, non-randomized trial of REOLYSIN® given intravenously with escalating doses of cyclophosphamide. A standard dose of REOLYSIN® is administered intravenously over five consecutive days, while an intravenous dose of cyclophosphamide is administered three days before REOLYSIN® treatment and continues through the course of the treatment cycle. The total number of patients studied will depend on the number of dose levels tested, but it is anticipated to be approximately 30 patients.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours including pancreatic, lung and ovarian cancers that are refractory to standard therapy or for which no curative standard therapy exists. The primary objectives of the trial include determining the Minimum Effective Immunomodulatory Dose of cyclophosphamide to obtain successful immune modulation. Secondary objectives include the safety profile of the combination and gathering any evidence of anti-tumour activity.
Thursday, October 25, 2007
Transcript: Brad Thompson Conference Call
The following is posted for informational purposes only and so that the text can be searched and referenced. Although I have made every effort to ensure accuracy, no warranties are made or implied. I encourage everyone to listen to the call here.
Transcript of Brad Thompson's Conference Call made October 24, 2007.
Good afternoon, ladies and gentlemen. And welcome to Oncolytics Biotech’s clinical program update call. At this time, all participants are in listen only mode.
Following the presentation we will conduct a question and answer session for analysts and institutional investors. I’d like to remind everyone that this conference call is being recorded today, Wednesday, October 24 at 2 P.M. eastern time.
I will now turn the conference over to Dr. Brad Thompson, President and Chief Executive Officer of Oncolytics. Dr. Thompson, please go ahead.
Brad Thompson: Thank you Luke.
Good day and welcome to the Oncolytics biotech, Inc. web cast. My intention today is to provide information regarding the cyclophosphamide Reolysin co-therapy trial announced yesterday, and also to provide brief update on our clinical trial and manufacturing program for our lead product Reolysin.
Before I begin, I would remind you that certain matters discussed during this web cast will constitute forward-looking statements that are subject to risk and uncertainties relating to Oncolytics future financial, clinical, or business performance. Actual results could differ materially from those anticipated in these forward-looking statements. Those factors which may are detailed with Canadian and US security commissions which can be accessed at www.sedar.com and www.sec.gov. Please note that Oncolytics is under no obligation to update any forward-looking statements discussed today and investors are cautioned not to put undue reliance on these statements
As a reminder, Reolysin is Oncolytics’ formulation of the reovirus. A naturally occurring virus widely found in the environment. It has not been genetically altered or engineered. Reolysin is neither a gene therapy nor a cancer vaccine.
It is composed of a fully replication competent virus that is able to directly kill tumor cells that have an activated Ras pathways. Approximately two thirds of all cancers and virtually all metastatic disease has an activated Ras pathway. This is very important when you consider the potential of this product in a commercial context. Ras targeted therapeutics have potentially broad applications in cancer therapy.
For the last 18 months we have learned that Reolysin causes the death of cancer cells in two ways:
First, as the results of the normal viral infection of the Ras activated cell. The virus enters these cells then replicates which then causes subsequent cell death. Virus is therefore directly cytotoxic. The second is a result of the first. Various studies conducted by our colleagues in the US and the UK have verified that the viral induced cell death generates a secondary immune response against tumors.
Oncolytics clinical development strategy for Reolysin integrates both clinical and business objectives. Our business objective is to maximize the potential usage and therefore sales of Reolysin. We are developing Reolysin as an appropriate alternative to or addition to the standard of care treatment of a broad range of cancers. This business objective can be achieved however after regulatory approval of Reolysin. Those approvals require a carefully planned and executed clinical program designed to prove safety and efficacy of Reolysin. At the present time, we are examining the use of Reolysin using either a local or intravenous delivery depending on the trial. We are currently studying Reolysin as a monotherapy and in combination with radiation and chemotherapy. To date we have treated 139 patients in our clinical trials. Reolysin has been well-tolerated and anti-tumor activity has been observed in all trials reported on to date.
Results from two separate phase I IV monotherapy studies, one US and one in the UK, have been presented. Several important points from these studies are relevant to future studies.
First is that the product was well tolerated in humans at the highest dose and with multiple administrations. This finding allows us to examine Reolysin in a phase II environment, which we are now doing. Second is that the product is produces specific tumor clinical responses in patients at sites in the body away from the sites of administration. These responses are measured by objective tumor response, tumor marker response, and/or confirmed histopathology. These effects are noted in patients with a functional immune system that respond to in the exposure of the virus. The immune system apparently does not block the virus from reaching the tumor and replicating within it. In other words we use Reolysin on its own, we know that it can navigate past various physical barriers and the body's immune defenses, reaching and infecting tumors in a variety of locations in the body and then replicating in them. As a result we've proceeded to multiple phase II program examining the effects of Reolysin delivered intravenously as a monotherapy, sarcomas, and in conjunction with the National Cancer Institute, melanomas and ovarian cancer. Both of these studies will help us to determine the products future direction as a monotherapy.
Results emerging from our monotherapy program are very exciting, however, some equally exciting basic research conducted in a number of laboratories has indicated that immune modulation may improve response rate in clinical studies rather markedly. The exact mechanism has not yet been determined. A number of studies using cyclosporine or cyclophosphamide in combination with Reovirus in animal models, demonstrated increased tumor response, and/or survival, compared with the virus itself.
Most significantly, in many cases, the animals became tumor free after treatment with the combination. Further animal studies have revealed that the best dosage regime that minimizes toxicity and retains efficacy is when cyclophosphamide is administered before Reolysin administration begins. This indicates that transient immune modulation may work best.
The study announced yesterday follows this dosage regime. The varying doses of cyclophosphamide given and day minus 3 combined with constant IV Reolysin from day 1 to day 5 at 3x10th TCID 50 per day, which is a standard IV dosage.
The primary goal of this study is to measure the minimum dose of cyclophosphamide that cause immunomodulation measured in number of indicators including anti-body levels, T and B cell responses to determine when immunomodulation occurs. This is one of the studies that if successful will be heralded as a major breakthrough.
Turning to our review of our ongoing monotherapy trials, we are continuing to enroll patients in our phase I component of our glioblastoma in the US. The phase II sarcoma in the US is all also actively enrolling.
Enrollment in the NCI sponsored phase II melanoma study should commence in the very near future as NCI filed its protocol with the USFDA this past spring. Our combination therapy studies continue at pace as well, as noted at the AACR meeting today in San Francisco, we have one patient left to treat in our UK-phase Ia/Ib trial testing intratumoural administration of Reolysin in combination with radiation. We issued a news release on September 28th outlining positive interim results of that trial study and further results of that Ia/Ib trial are being presented at the AACR conference as we speak.
UK phase II combination trial testing local delivery of Reolysin in combination with radiation is also ongoing. Enrollment in the dose escalation component of our three drug combination studies in the UK is also continuing. Once the dose escalation components are completed, we’ll move directly into constant dose cohorts for all three studies.
As we said in the past the goals not only to come up the product as efficacy, but one that is commercially viable and can be produce a commercial scale. From this basis we have advanced our manufacturing initiatives parallel to clinical development of the product. Recently we have completed the initial scale up of our manufacturing process to 100 liters, which is for us commercial scale.
Through the exercise we have instituted a number of process improvements that have resulted in increase of total yield. Once we have confirmed this data will be reporting on the specific results of the 100 L scale. That concludes my comments today. I’d like to thank you for your time and attention this afternoon and remind you that this presentation will be archived on our website for 90 days. Operator we are now ready for questions.
Operator Luke: Ladies and gentlemen will now conduct the question and answer session. Your first question comes from David Miller from Biotech Stock Research, please go ahead.
David Miller: Hey good morning guys from the AACR conference. Thanks for having the call and updating us. The first question I have is that with the result that you are seeing in and combination with particularly cyclophosphamide is that… at what impact will that have on the trials are ready have running or what trials you might launch next.
BT: That's a very interesting question, if you can parallel the results we saw animals to humans using cyclophosphamide in combination with Reovirus I think you're going to see a...and I hate to say this because I think it cliché…a major paradigm shift in the viral therapy area.
What we're faced with is a relatively good response rates with the product as a monotherapy. And if we've prove that for this study as a monotherapy it certainly would be more than suitable to carry on and get the product approved. But it would always be less than the theoretical and the use of immune modulators is in our opinion and many other people’s opinion a possible way to push these responses up to the theoretical maximum. If we get that it's going to entail a complete rethinking of this whole viral therapy area. If you are getting response rates up to what like what we are seeing in animals. We have a bit of a conundrum because then you have a new therapy coming through that will be completely competitive with frontline therapies all by its self. I think we'll be a little bit reluctant to combine cyclophosphamide, Reolysin and say anyone of the taxhol in one cocktail. So our plan would be if the results are as we hope they are in the cyclophosphamide study to move directly to a fairly large phase 2 study and then really pin down what a registration path would be with that.
DM: You've done some humans with this combo though haven’t you with Reolysin they’ve got some cyclophosphamide, or no?
BT: No, we have not. In some of our other studies have immune modulation by default, if you want to think of it that way. Certainly radiation co-therapy, sterilization of immune system if you want to call it that in the radiation field. When you look at antibody responses radiation study, which is now out, you don't get nearly the antibody responses with Reolysin combined with radiation than you would with Reolysin alone. Also things like gemzar immune modulator…and we are conducting a study in the UK so we have a number of “immune modulation-ish” components going on in existence. But this one is the first deliberate attempt to directly modulate the immune system at dosages that are clearly sub-clinical for cyclophosphamide as a chemotherapeutic. This is directly interfering with the immune system in a way that should result, again if it mirrors the animal model, in some very interesting clinical responses.
DM: So the key mechanism of action here that you think is that is something as simple that it down regulates the antibody response so you're just not having as many of your viral particles mopped up by the immune system.
BT: I think we have a lot of correlation but no causation in the immune data we have to date. I’m not sure if antibodies are or a non-antibody B-cell subclass or one of those T-cells subclasses that we are down regulating.
As you know, a lot of immune modulators down and up regulate certain classes simultaneously. That certainly the case…it's one of those things that I don’t think we’ll see until we look for it. And for all I know the first signal that we’re getting is that we’re seeing very different clinical responses and we’ll have to backtrack to find out what it is.
This is really groundbreaking work, this particular study, I think it will get us away from the correlation and get us into the causation specifically in the immune system.
DM: You also mentioned that 100L scale up going, congratulations on that, I know that was a big stepping stone for talking to partners. Can you go over again what's next in that process and how soon the manufacturing lots from that we’ll be seeing in the clinical trials.
BT: We’re currently working at the 40L scale with our first clinical lots starting to come through with that…which is, we were working at the 20L scale before. The key for us is for the manufacturing to get up to that level is actually two purposes. One is thinking ahead towards future sales of course. And as you know with biologics a lot of the process look interesting in the clinic, but then people can make them or they cost too much or something like that or they are not reproducible.
So we've spent a lot of time and energy specifically on that for the long term view. The medium term view is to produce enough clinical material to support very large scale studies which are coming right up to the gates now. And one 40L batch, just as an example, is enough to crank out more than 20,000 dosages for our maximum IV dosages. Assuming we near those at the 100L scale we can run a pivotal study on a 100L run. And that’s critical. Critical supply in biologics is often constricting factor in enrollment, and we won't have that.
The third part of course is the partnering. Partners are shy at the biologic processes and they like to see it at a commercial scale. A 100L should be to commercial scale for us a 100L facility would crank up between a million and a million and a half dosages per year just out of a single tank. And that’s certainly enough for a launch of a product.
DM: Alright, and just make sure that I’m certain about this, you have produced at the 100L scale?
BT: We’ve done our initial 100L run and we are just re-doing it, because we have to confirm these things. Once does not a process make. Twice does. So later this year will be completing that work and will certainly announce the final data off of that. And to finish off your question (then we’ll transfer over), we’ll do clinical lots, the expectation is we’ll do our first 100L clinical lot in 2008.
DM: Thanks very much for answering my questions.
BT: Thank you.
Luke: Your next questions comes from Joe Pantginis from Canaccord Adams
Joe Pantginis: Hi Brad, good afternoon, thanks for doing the call. A couple of quick question, really sort of tied together, granted pivotal programs, etc., will be driven by the data, and you know, the new cyclophosphamide study, but with that in mind can you give us an idea of what your initial commercialization strategy might look like and just tying into that can you remind us again, what your partnering strategy is up to date right now. Thanks a lot.
BT: As we talked about before, one of the good and bad things about Reolysin is that it’s very broadly active within each cancer indication and is apparently synergistic with virtually everything at least in the lab, which complicates your clinical studies in the early days. Presumably when we get it approved it would be lovely to have that kind of activity. So what we’ve done is set up a clinical program that…basically the two sides of the coin. We’ve picked on the monotherapy side, I would certainly focus time and attention on the registration paths on the sarcoma study. It’s one of the few monotherapy areas where I could believe that we can actually make Reolysin the standard of care for particular indication. Patients with sarcoma that have pulmonary involvement don't have a standard care. So something coming through could be considered that. For the rest of the world, for the rest of things, we have to be looking into being incorporated with existing standards of care. And certainly the results from the three drug combination studies that are ongoing in the UK, plus the radiation combination therapy, will lead toward registrations paths and we believe that probably two of those will be ready to move on to the registration paths. It's really hard to anticipate which of the drug combinations. I’m pretty comfortable that there is a radiation co-therapy registration path. So you’re looking at a monotherapy, probably in a sarcoma, or a related disease. The combination with radiation moving in and one of the drug combinations. Again, as you just said the wild card is the cyclophosphamide study. If it doesn't work I will be glad that we had done it, because then we know that immune modulation at least of that kind doesn’t make a difference. And that’s just important to know. I think it would bother me for the rest of my life if we didn’t try it. It’s too enticing to see what a difference it makes. Because if it looks like it does in the animals then would be very very glad we did it. If it works on up side then all bets are off. It will really change our thinking about everything.
With respect to partnering people that we talk to are being consistent with what they would like to see out of this program from the very start. They want to see that we can make it, the product, they want to see if we can generate an IP base, the want to see that it’s safe in relatively large number of patients and we’ve certainly passed that milestone. And to see a variety of early phase II data, which we’ll have for people starting next year. I would anticipate that once we have that data in hand than then that process will proceed as we all hope it does.
JP: Great. Thanks Brad.
Luke: Your next question is a follow up from David Miller of Biotech Stock Research
DM: What’s the timing and the starting of the cyclophosphamide combo in humans.
BT: Starting from when the first patients enroll?
DM: When will the trial start and when will we see data?
BM: well we actually have more…we’ve paralleled tracked a lot of the approvals that you have to through in the UK, along with MHRA. I think that one or two committees left to go through. We have site initiations scheduled for next month. So, one would hope that we would be in enrolling certainly before Christmas. And I think given the interest sites have expressed in this. I know they are already looking for patients, enrollment should go fairly expeditiously. The big question is at what dosage do you see any modulation at. If you see it in that first cohort it would be done after those three patients. I mean we will enroll more patients at that constant dose but you'll be moving straight into a phase II very quickly. So it really depends on that dosage and I think we’ll be kind of wanting to report on it on a regular basis, in real time, because there is a huge amount of interest in this particular study. I have more were people look over my shoulder for this study that I ever thought possible. It's just a really interesting study and all the other viral companies of course are interested in its outcome too, because if it works out then expect you’ll see this kind of thing incorporated in other people’s therapies as well.
DM: Great thanks.
Luke: Dr. Thompson, there are no further questions at this time please continue.
BT: I’d just like to thank everybody for their time and attention. I know especially for all those people down at AACR down in San Francisco would have to take time out from other meetings to come and listen to the call. Again, if anybody has any comments or questions. They’d like to direct off line. They can contact us at Oncolytics Biotech Inc. would be happy to discuss anything. Thank you for your attendance.
Transcript of Brad Thompson's Conference Call made October 24, 2007.
Good afternoon, ladies and gentlemen. And welcome to Oncolytics Biotech’s clinical program update call. At this time, all participants are in listen only mode.
Following the presentation we will conduct a question and answer session for analysts and institutional investors. I’d like to remind everyone that this conference call is being recorded today, Wednesday, October 24 at 2 P.M. eastern time.
I will now turn the conference over to Dr. Brad Thompson, President and Chief Executive Officer of Oncolytics. Dr. Thompson, please go ahead.
Brad Thompson: Thank you Luke.
Good day and welcome to the Oncolytics biotech, Inc. web cast. My intention today is to provide information regarding the cyclophosphamide Reolysin co-therapy trial announced yesterday, and also to provide brief update on our clinical trial and manufacturing program for our lead product Reolysin.
Before I begin, I would remind you that certain matters discussed during this web cast will constitute forward-looking statements that are subject to risk and uncertainties relating to Oncolytics future financial, clinical, or business performance. Actual results could differ materially from those anticipated in these forward-looking statements. Those factors which may are detailed with Canadian and US security commissions which can be accessed at www.sedar.com and www.sec.gov. Please note that Oncolytics is under no obligation to update any forward-looking statements discussed today and investors are cautioned not to put undue reliance on these statements
As a reminder, Reolysin is Oncolytics’ formulation of the reovirus. A naturally occurring virus widely found in the environment. It has not been genetically altered or engineered. Reolysin is neither a gene therapy nor a cancer vaccine.
It is composed of a fully replication competent virus that is able to directly kill tumor cells that have an activated Ras pathways. Approximately two thirds of all cancers and virtually all metastatic disease has an activated Ras pathway. This is very important when you consider the potential of this product in a commercial context. Ras targeted therapeutics have potentially broad applications in cancer therapy.
For the last 18 months we have learned that Reolysin causes the death of cancer cells in two ways:
First, as the results of the normal viral infection of the Ras activated cell. The virus enters these cells then replicates which then causes subsequent cell death. Virus is therefore directly cytotoxic. The second is a result of the first. Various studies conducted by our colleagues in the US and the UK have verified that the viral induced cell death generates a secondary immune response against tumors.
Oncolytics clinical development strategy for Reolysin integrates both clinical and business objectives. Our business objective is to maximize the potential usage and therefore sales of Reolysin. We are developing Reolysin as an appropriate alternative to or addition to the standard of care treatment of a broad range of cancers. This business objective can be achieved however after regulatory approval of Reolysin. Those approvals require a carefully planned and executed clinical program designed to prove safety and efficacy of Reolysin. At the present time, we are examining the use of Reolysin using either a local or intravenous delivery depending on the trial. We are currently studying Reolysin as a monotherapy and in combination with radiation and chemotherapy. To date we have treated 139 patients in our clinical trials. Reolysin has been well-tolerated and anti-tumor activity has been observed in all trials reported on to date.
Results from two separate phase I IV monotherapy studies, one US and one in the UK, have been presented. Several important points from these studies are relevant to future studies.
First is that the product was well tolerated in humans at the highest dose and with multiple administrations. This finding allows us to examine Reolysin in a phase II environment, which we are now doing. Second is that the product is produces specific tumor clinical responses in patients at sites in the body away from the sites of administration. These responses are measured by objective tumor response, tumor marker response, and/or confirmed histopathology. These effects are noted in patients with a functional immune system that respond to in the exposure of the virus. The immune system apparently does not block the virus from reaching the tumor and replicating within it. In other words we use Reolysin on its own, we know that it can navigate past various physical barriers and the body's immune defenses, reaching and infecting tumors in a variety of locations in the body and then replicating in them. As a result we've proceeded to multiple phase II program examining the effects of Reolysin delivered intravenously as a monotherapy, sarcomas, and in conjunction with the National Cancer Institute, melanomas and ovarian cancer. Both of these studies will help us to determine the products future direction as a monotherapy.
Results emerging from our monotherapy program are very exciting, however, some equally exciting basic research conducted in a number of laboratories has indicated that immune modulation may improve response rate in clinical studies rather markedly. The exact mechanism has not yet been determined. A number of studies using cyclosporine or cyclophosphamide in combination with Reovirus in animal models, demonstrated increased tumor response, and/or survival, compared with the virus itself.
Most significantly, in many cases, the animals became tumor free after treatment with the combination. Further animal studies have revealed that the best dosage regime that minimizes toxicity and retains efficacy is when cyclophosphamide is administered before Reolysin administration begins. This indicates that transient immune modulation may work best.
The study announced yesterday follows this dosage regime. The varying doses of cyclophosphamide given and day minus 3 combined with constant IV Reolysin from day 1 to day 5 at 3x10th TCID 50 per day, which is a standard IV dosage.
The primary goal of this study is to measure the minimum dose of cyclophosphamide that cause immunomodulation measured in number of indicators including anti-body levels, T and B cell responses to determine when immunomodulation occurs. This is one of the studies that if successful will be heralded as a major breakthrough.
Turning to our review of our ongoing monotherapy trials, we are continuing to enroll patients in our phase I component of our glioblastoma in the US. The phase II sarcoma in the US is all also actively enrolling.
Enrollment in the NCI sponsored phase II melanoma study should commence in the very near future as NCI filed its protocol with the USFDA this past spring. Our combination therapy studies continue at pace as well, as noted at the AACR meeting today in San Francisco, we have one patient left to treat in our UK-phase Ia/Ib trial testing intratumoural administration of Reolysin in combination with radiation. We issued a news release on September 28th outlining positive interim results of that trial study and further results of that Ia/Ib trial are being presented at the AACR conference as we speak.
UK phase II combination trial testing local delivery of Reolysin in combination with radiation is also ongoing. Enrollment in the dose escalation component of our three drug combination studies in the UK is also continuing. Once the dose escalation components are completed, we’ll move directly into constant dose cohorts for all three studies.
As we said in the past the goals not only to come up the product as efficacy, but one that is commercially viable and can be produce a commercial scale. From this basis we have advanced our manufacturing initiatives parallel to clinical development of the product. Recently we have completed the initial scale up of our manufacturing process to 100 liters, which is for us commercial scale.
Through the exercise we have instituted a number of process improvements that have resulted in increase of total yield. Once we have confirmed this data will be reporting on the specific results of the 100 L scale. That concludes my comments today. I’d like to thank you for your time and attention this afternoon and remind you that this presentation will be archived on our website for 90 days. Operator we are now ready for questions.
Operator Luke: Ladies and gentlemen will now conduct the question and answer session. Your first question comes from David Miller from Biotech Stock Research, please go ahead.
David Miller: Hey good morning guys from the AACR conference. Thanks for having the call and updating us. The first question I have is that with the result that you are seeing in and combination with particularly cyclophosphamide is that… at what impact will that have on the trials are ready have running or what trials you might launch next.
BT: That's a very interesting question, if you can parallel the results we saw animals to humans using cyclophosphamide in combination with Reovirus I think you're going to see a...and I hate to say this because I think it cliché…a major paradigm shift in the viral therapy area.
What we're faced with is a relatively good response rates with the product as a monotherapy. And if we've prove that for this study as a monotherapy it certainly would be more than suitable to carry on and get the product approved. But it would always be less than the theoretical and the use of immune modulators is in our opinion and many other people’s opinion a possible way to push these responses up to the theoretical maximum. If we get that it's going to entail a complete rethinking of this whole viral therapy area. If you are getting response rates up to what like what we are seeing in animals. We have a bit of a conundrum because then you have a new therapy coming through that will be completely competitive with frontline therapies all by its self. I think we'll be a little bit reluctant to combine cyclophosphamide, Reolysin and say anyone of the taxhol in one cocktail. So our plan would be if the results are as we hope they are in the cyclophosphamide study to move directly to a fairly large phase 2 study and then really pin down what a registration path would be with that.
DM: You've done some humans with this combo though haven’t you with Reolysin they’ve got some cyclophosphamide, or no?
BT: No, we have not. In some of our other studies have immune modulation by default, if you want to think of it that way. Certainly radiation co-therapy, sterilization of immune system if you want to call it that in the radiation field. When you look at antibody responses radiation study, which is now out, you don't get nearly the antibody responses with Reolysin combined with radiation than you would with Reolysin alone. Also things like gemzar immune modulator…and we are conducting a study in the UK so we have a number of “immune modulation-ish” components going on in existence. But this one is the first deliberate attempt to directly modulate the immune system at dosages that are clearly sub-clinical for cyclophosphamide as a chemotherapeutic. This is directly interfering with the immune system in a way that should result, again if it mirrors the animal model, in some very interesting clinical responses.
DM: So the key mechanism of action here that you think is that is something as simple that it down regulates the antibody response so you're just not having as many of your viral particles mopped up by the immune system.
BT: I think we have a lot of correlation but no causation in the immune data we have to date. I’m not sure if antibodies are or a non-antibody B-cell subclass or one of those T-cells subclasses that we are down regulating.
As you know, a lot of immune modulators down and up regulate certain classes simultaneously. That certainly the case…it's one of those things that I don’t think we’ll see until we look for it. And for all I know the first signal that we’re getting is that we’re seeing very different clinical responses and we’ll have to backtrack to find out what it is.
This is really groundbreaking work, this particular study, I think it will get us away from the correlation and get us into the causation specifically in the immune system.
DM: You also mentioned that 100L scale up going, congratulations on that, I know that was a big stepping stone for talking to partners. Can you go over again what's next in that process and how soon the manufacturing lots from that we’ll be seeing in the clinical trials.
BT: We’re currently working at the 40L scale with our first clinical lots starting to come through with that…which is, we were working at the 20L scale before. The key for us is for the manufacturing to get up to that level is actually two purposes. One is thinking ahead towards future sales of course. And as you know with biologics a lot of the process look interesting in the clinic, but then people can make them or they cost too much or something like that or they are not reproducible.
So we've spent a lot of time and energy specifically on that for the long term view. The medium term view is to produce enough clinical material to support very large scale studies which are coming right up to the gates now. And one 40L batch, just as an example, is enough to crank out more than 20,000 dosages for our maximum IV dosages. Assuming we near those at the 100L scale we can run a pivotal study on a 100L run. And that’s critical. Critical supply in biologics is often constricting factor in enrollment, and we won't have that.
The third part of course is the partnering. Partners are shy at the biologic processes and they like to see it at a commercial scale. A 100L should be to commercial scale for us a 100L facility would crank up between a million and a million and a half dosages per year just out of a single tank. And that’s certainly enough for a launch of a product.
DM: Alright, and just make sure that I’m certain about this, you have produced at the 100L scale?
BT: We’ve done our initial 100L run and we are just re-doing it, because we have to confirm these things. Once does not a process make. Twice does. So later this year will be completing that work and will certainly announce the final data off of that. And to finish off your question (then we’ll transfer over), we’ll do clinical lots, the expectation is we’ll do our first 100L clinical lot in 2008.
DM: Thanks very much for answering my questions.
BT: Thank you.
Luke: Your next questions comes from Joe Pantginis from Canaccord Adams
Joe Pantginis: Hi Brad, good afternoon, thanks for doing the call. A couple of quick question, really sort of tied together, granted pivotal programs, etc., will be driven by the data, and you know, the new cyclophosphamide study, but with that in mind can you give us an idea of what your initial commercialization strategy might look like and just tying into that can you remind us again, what your partnering strategy is up to date right now. Thanks a lot.
BT: As we talked about before, one of the good and bad things about Reolysin is that it’s very broadly active within each cancer indication and is apparently synergistic with virtually everything at least in the lab, which complicates your clinical studies in the early days. Presumably when we get it approved it would be lovely to have that kind of activity. So what we’ve done is set up a clinical program that…basically the two sides of the coin. We’ve picked on the monotherapy side, I would certainly focus time and attention on the registration paths on the sarcoma study. It’s one of the few monotherapy areas where I could believe that we can actually make Reolysin the standard of care for particular indication. Patients with sarcoma that have pulmonary involvement don't have a standard care. So something coming through could be considered that. For the rest of the world, for the rest of things, we have to be looking into being incorporated with existing standards of care. And certainly the results from the three drug combination studies that are ongoing in the UK, plus the radiation combination therapy, will lead toward registrations paths and we believe that probably two of those will be ready to move on to the registration paths. It's really hard to anticipate which of the drug combinations. I’m pretty comfortable that there is a radiation co-therapy registration path. So you’re looking at a monotherapy, probably in a sarcoma, or a related disease. The combination with radiation moving in and one of the drug combinations. Again, as you just said the wild card is the cyclophosphamide study. If it doesn't work I will be glad that we had done it, because then we know that immune modulation at least of that kind doesn’t make a difference. And that’s just important to know. I think it would bother me for the rest of my life if we didn’t try it. It’s too enticing to see what a difference it makes. Because if it looks like it does in the animals then would be very very glad we did it. If it works on up side then all bets are off. It will really change our thinking about everything.
With respect to partnering people that we talk to are being consistent with what they would like to see out of this program from the very start. They want to see that we can make it, the product, they want to see if we can generate an IP base, the want to see that it’s safe in relatively large number of patients and we’ve certainly passed that milestone. And to see a variety of early phase II data, which we’ll have for people starting next year. I would anticipate that once we have that data in hand than then that process will proceed as we all hope it does.
JP: Great. Thanks Brad.
Luke: Your next question is a follow up from David Miller of Biotech Stock Research
DM: What’s the timing and the starting of the cyclophosphamide combo in humans.
BT: Starting from when the first patients enroll?
DM: When will the trial start and when will we see data?
BM: well we actually have more…we’ve paralleled tracked a lot of the approvals that you have to through in the UK, along with MHRA. I think that one or two committees left to go through. We have site initiations scheduled for next month. So, one would hope that we would be in enrolling certainly before Christmas. And I think given the interest sites have expressed in this. I know they are already looking for patients, enrollment should go fairly expeditiously. The big question is at what dosage do you see any modulation at. If you see it in that first cohort it would be done after those three patients. I mean we will enroll more patients at that constant dose but you'll be moving straight into a phase II very quickly. So it really depends on that dosage and I think we’ll be kind of wanting to report on it on a regular basis, in real time, because there is a huge amount of interest in this particular study. I have more were people look over my shoulder for this study that I ever thought possible. It's just a really interesting study and all the other viral companies of course are interested in its outcome too, because if it works out then expect you’ll see this kind of thing incorporated in other people’s therapies as well.
DM: Great thanks.
Luke: Dr. Thompson, there are no further questions at this time please continue.
BT: I’d just like to thank everybody for their time and attention. I know especially for all those people down at AACR down in San Francisco would have to take time out from other meetings to come and listen to the call. Again, if anybody has any comments or questions. They’d like to direct off line. They can contact us at Oncolytics Biotech Inc. would be happy to discuss anything. Thank you for your attendance.
Wednesday, October 24, 2007
Oncolytics Biotech Inc. Collaborators to Present Positive Interim Results of U.K. Phase Ia/Ib Combination REOLYSIN® and Radiation Clinical Trial
From the website.
10/24/2007 2:00:00 AM ET
CALGARY, AB, --- October 24, 2007 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) today announced that a poster presentation covering interim results from a U.K. Phase Ia/Ib combination REOLYSIN®/radiation clinical trial for patients with advanced or metastatic cancers is scheduled to be presented today at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in San Francisco. The conference runs from October 22-26, 2007.
“We are very encouraged with the results of this trial to date,” said Dr. Brad Thompson, President and CEO of Oncolytics. “The data is supportive of our ongoing Phase II REOLYSIN®/radiation cotherapy trial in the U.K.”
The interim results of the Ia/Ib trial demonstrate that intratumoural treatment with REOLYSIN® and radiation is well tolerated and results in both local and remote anti-tumour activity in patients with a variety of advanced cancers. Oncolytics continues to enroll patients in the Ib portion of this trial, and is also actively enrolling patients in a Phase II trial examining this treatment combination.
The presentation, entitled “A Phase I study to evaluate the feasibility, safety and biological effects of intratumoural administration of wild-type Reovirus (REOLYSIN®) in combination with radiation in patients with advanced malignancies” will be delivered by Dr. Dean Harris of The Institute of Cancer Research, London.
These interim results were also presented in early October at the National Cancer Research Institute (NCRI) Cancer Conference in Birmingham, U.K.The poster presentation will be posted on the Oncolytics website today at www.oncolyticsbiotech.com.
10/24/2007 2:00:00 AM ET
CALGARY, AB, --- October 24, 2007 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) today announced that a poster presentation covering interim results from a U.K. Phase Ia/Ib combination REOLYSIN®/radiation clinical trial for patients with advanced or metastatic cancers is scheduled to be presented today at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in San Francisco. The conference runs from October 22-26, 2007.
“We are very encouraged with the results of this trial to date,” said Dr. Brad Thompson, President and CEO of Oncolytics. “The data is supportive of our ongoing Phase II REOLYSIN®/radiation cotherapy trial in the U.K.”
The interim results of the Ia/Ib trial demonstrate that intratumoural treatment with REOLYSIN® and radiation is well tolerated and results in both local and remote anti-tumour activity in patients with a variety of advanced cancers. Oncolytics continues to enroll patients in the Ib portion of this trial, and is also actively enrolling patients in a Phase II trial examining this treatment combination.
The presentation, entitled “A Phase I study to evaluate the feasibility, safety and biological effects of intratumoural administration of wild-type Reovirus (REOLYSIN®) in combination with radiation in patients with advanced malignancies” will be delivered by Dr. Dean Harris of The Institute of Cancer Research, London.
These interim results were also presented in early October at the National Cancer Research Institute (NCRI) Cancer Conference in Birmingham, U.K.The poster presentation will be posted on the Oncolytics website today at www.oncolyticsbiotech.com.
Tuesday, October 23, 2007
NEWS RELEASE
From the website.
10/23/2007
5:13:16 PM ET
Oncolytics Biotech Inc. Announces Approval for U.K. Clinical Trial Investigating REOLYSIN® in Combination with Cyclophosphamide
CALGARY, AB, --- October 23, 2007 -
Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that it has received a letter of approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for its Clinical Trial Application (CTA) to begin a clinical trial using intravenous administration of REOLYSIN® in combination with cyclophosphamide, a chemotherapeutic agent as well as immune modulator, in patients with advanced cancers.
The Principal Investigators are Dr. James Spicer of King’s College in London, Dr. Johann de Bono and Dr. Kevin Harrington of The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, and Professor Hardev Pandha of the Royal Surrey County Hospital NHS Trust, Surrey and Mount Alvernia Hospitals.
The Company also intends to host a conference call Wednesday, October 24, 2007 to provide an update on its expanding clinical program. The dial-in details appear below.
“We are really looking forward to treating patients in this trial,” said Principal Investigator Dr. James Spicer. “The hope is that it will provide valuable information about the relationship between oncolytic viral therapy and the immune response of the patient.”
The trial (REO 012) is an open-label, dose-escalating, non-randomized trial of REOLYSIN® given intravenously with escalating doses of cyclophosphamide. A standard dose of REOLYSIN® is administered intravenously over five consecutive days, while an intravenous dose of cyclophosphamide is administered three days before REOLYSIN® treatment and continues through the course of the treatment cycle. The total number of patients studied will depend on the number of dose levels tested, but it is anticipated to be approximately 30 patients.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours including pancreatic, lung and ovarian cancers that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists.
The primary objectives of the trial include determining the Minimum Effective Immunomodulatory Dose (MED) of cyclophosphamide to obtain successful immune modulation. Secondary objectives include the safety profile of the combination and gathering any evidence of anti-tumour activity.
Conference Call Details
Oncolytics will host a conference call at 2:00 p.m. EST on Wednesday, October 24, 2007, to provide a general update on its ongoing clinical trial program.
To access the conference call by telephone, dial 1-416-644-3414 or 1-800-731-5319. A live audio webcast will be available at: http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=2054580 or through the Company’s website at http://www.oncolyticsbiotech.com/.
Please connect at least 15 minutes prior to the webcast to ensure adequate time for any software download that may be needed. A replay of the webcast will be available at www.oncolyticsbiotech.com and will also be available by telephone through October 31, 2007. To access the telephone replay, dial 1-416-640-1917 or 1-877-289-8525 and enter reservation number 21251367#.
10/23/2007
5:13:16 PM ET
Oncolytics Biotech Inc. Announces Approval for U.K. Clinical Trial Investigating REOLYSIN® in Combination with Cyclophosphamide
CALGARY, AB, --- October 23, 2007 -
Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that it has received a letter of approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for its Clinical Trial Application (CTA) to begin a clinical trial using intravenous administration of REOLYSIN® in combination with cyclophosphamide, a chemotherapeutic agent as well as immune modulator, in patients with advanced cancers.
The Principal Investigators are Dr. James Spicer of King’s College in London, Dr. Johann de Bono and Dr. Kevin Harrington of The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, and Professor Hardev Pandha of the Royal Surrey County Hospital NHS Trust, Surrey and Mount Alvernia Hospitals.
The Company also intends to host a conference call Wednesday, October 24, 2007 to provide an update on its expanding clinical program. The dial-in details appear below.
“We are really looking forward to treating patients in this trial,” said Principal Investigator Dr. James Spicer. “The hope is that it will provide valuable information about the relationship between oncolytic viral therapy and the immune response of the patient.”
The trial (REO 012) is an open-label, dose-escalating, non-randomized trial of REOLYSIN® given intravenously with escalating doses of cyclophosphamide. A standard dose of REOLYSIN® is administered intravenously over five consecutive days, while an intravenous dose of cyclophosphamide is administered three days before REOLYSIN® treatment and continues through the course of the treatment cycle. The total number of patients studied will depend on the number of dose levels tested, but it is anticipated to be approximately 30 patients.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours including pancreatic, lung and ovarian cancers that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists.
The primary objectives of the trial include determining the Minimum Effective Immunomodulatory Dose (MED) of cyclophosphamide to obtain successful immune modulation. Secondary objectives include the safety profile of the combination and gathering any evidence of anti-tumour activity.
Conference Call Details
Oncolytics will host a conference call at 2:00 p.m. EST on Wednesday, October 24, 2007, to provide a general update on its ongoing clinical trial program.
To access the conference call by telephone, dial 1-416-644-3414 or 1-800-731-5319. A live audio webcast will be available at: http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=2054580 or through the Company’s website at http://www.oncolyticsbiotech.com/.
Please connect at least 15 minutes prior to the webcast to ensure adequate time for any software download that may be needed. A replay of the webcast will be available at www.oncolyticsbiotech.com and will also be available by telephone through October 31, 2007. To access the telephone replay, dial 1-416-640-1917 or 1-877-289-8525 and enter reservation number 21251367#.
Monday, October 22, 2007
Abstract from AACR-NCI-EORTC Conference
The AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics gets underway in a few hours. Abstracts were released this morning, the following is the abstract in interest to Oncolytics Biotech followers:
B81 A Phase I study to evaluate the feasibility, safety and biological effects of intratumoural administration of wild-type Reovirus (REOLYSIN®) in combination with radiation in patients with advanced malignancies.
Dean Harris1, Laura Vidal1, Alan Melcher2, Kate Newbold1, Alan Anthony2, Vasilios Karavasilis1, Roshan Agarwal1, Chris White3, Katie Twigger3, Matt Coffey4, Karl Mettinger4, Brad Thompson4, Hardev Pandha5, Johann De-Bono1, Kevin Harrington1.
1Royal Marsden Hospital, Sutton, Surrey, United Kingdom; 2St James Hospital, Leeds, United Kingdom; 3Institue of Cancer Research, Sutton, Surrey, United Kingdom; 4Oncolytics, Calgary, Alberta, Canada; 5University of Surrey, Guildford, Surrey, United Kingdom.
Background: Wild-type reovirus (REOLYSIN®) is a dsRNA virus which results in asymptomatic infection in humans and has been demonstrated to replicate in and prove cytopathic to Ras activated cells, while sparing
normal cells.
Methods: An open label, dose escalating, multicentre phase I study of intratumoural injections of REOLYSIN with concurrent fractionated radiotherapy in patients with advanced solid tumours. The primary objectives are to determine the feasibility and safety of this intervention as well as assessing the antitumour activity, viral replication and the development of immune response. Patients were treated in sequential 3-patient cohorts. The treatment plan initially involved local irradiation of 20Gy in 5 consecutive daily fractions in combination with two intratumour injections of REOLYSIN (108 TCID50 on days 2 and 4 in week 1) with successive cohorts receiving escalating doses of virus to a maximum 1010TCID50 . As no dose-limiting toxicity (DLT) was encountered the radiotherapy dose was increased up to 36Gy in 12 fractions. The number of REOLYSIN injections were escalated in conjunction from two doses of 1010TCID50 (days 2 and 4 in week 1) for the first cohort then four doses of 1010TCID50 (days 2 and 4 in week 1 and days 9 and 11 week 2) and finally 6 doses of 1010TCID50 (days 2 and 4 in week 1 and days 9 and 11 week 2 and days 16 and 18 in week 3).
Tumour evaluation using imaging(RECIST criteria) or clinical examination was performed at days 33 and 61 in the 20Gy cohorts and days 29 and 59 in the 36Gy cohorts. Blood was collected for assessment of T cell subsets, T cell proliferation and cytokine production in association response to tumour associated antigens.
Results: 24 patients have been enrolled to date with 15 having completed the study (7 withdrawals/replacements and 2 patients still on study) with one patient required to complete the study. Treatment has been well tolerated with grade 3 toxicities of fatigue(4), hypokalaemia(3), tumour pain(1), tumour necrosis(1), diarrhoea(1), dysphagia(1), cellulitis(1) and anorexia(1) seen. Common grade 1 and 2 toxicities include lymphopenia, fatigue, vomiting, fever, rash and neutropenia. In the low dose cohort two pts (oesophageal and skin squamous carcinoma) had significant partial responses (PR) (70% and 50%) and stable disease(SD) of treated site was seen in 8 of 11 evaluable patients with disease progression noted at non treatment lesion sites in 2 of those with stable disease. Of note the patient with oesophageal cancer had a PR in nonirradiated mediastinal disease. In the high dose cohort 1 partial response(PR) (in colorectal cancer) in the 7 evaluable patients, and 6 SD were seen with one showing progression at non-treated sites.
Conclusion: The use of intratumoural injections of REOLYSIN combined with radiotherapy is tolerated without significant toxicity. The administration of multiple injections in association with radiotherapy is
feasible in selected patients. The data on immune response and viral replication is ongoing at present with the study nearing planned completion.
Friday, October 19, 2007
End of week two
What a day and what a perfect close to two straight weeks of high volume and stock appreciation. Looks like somebody really wanted to get a hold of some ONCY before the start of the AACR-NCI-EORTC International Conference. Looking forward to the news.
Thursday, October 18, 2007
AACR-NCI-EORTC Confrence Begins October 22, 2007
The AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics will begin this Monday, October 22, 2007 at the Moscone Convention Center in San Francisco, California. Scheduled to be presented at the conference, which runs through October 26th, will be interim results of the combination Reolysin and radiation trial.
View the program here.
View the program here.
Wednesday, October 17, 2007
Transcript: BIO InvestorForum 2007, Mary Ann Dillahunty
The following is posted for informational purposes only and so that the text can be searched and referenced. Although I have made every effort to ensure accuracy, no warranties are made or implied. I encourage everyone to listen to the presentation here.
BIO InvestorForum 2007
Ms. Mary Anne Dillahunty
Vice President, Intellectual Property
Oncolytics Biotech Inc.
October 11, 2007.
(Slide 1)Thank you. Good afternoon. Thank you for coming.
(Slide 2) I would like to draw your attention first of all to these forward-looking statements. We are a public company, so we are required to say this.
(Slide 3) Okay, Oncolytics' lead product is Reolysin which is a targeted anticancer therapy. It is a therapy based on a reovirus. And we have a broad-based phase II program, clinical trial program that is ongoing in the US and in the UK. In the clinical trials that we have done and we are doing, Reolysin has an excellent safety profile and its mechanism of action is actually directly cytotoxic in that we have seen tumour responses in a variety of cancers. With just single therapy with Reolysin itself, without any co-therapy. In addition, we have found that there are synergistic effects with the common chemotherapeutics and the conventional chemotherapies, and also with radiotherapy. Reolysin potentiates most cytotoxics that it has been tried in combination with. And we are now exploring that further with three combination trials that are enrolling patients.
And addition it has been shown to synergistically potentiate radiotherapy, and we are also enrolling patients in a phase II combination radiotherapy and local Reolysin program.
(Slide 4) So, this slide just gives an overview of what I plan to talk about today. I'll tell you a little bit about the mode of action of Reolysin, something about our intellectual property portfolio, our manufacturing, and the safety of Reolysin, and then go into a little bit of detail on our clinical trial program.
(Slide 5) Oncolytics Biotech Inc. is a Calgary Alberta Canada based company whose corporate focus is on the development of Oncolytic viruses for the treatment of cancer. We have what we think is a comprehensive and ongoing clinical program with our lead product Reolysin. And in addition to having the program planned, we have the funding in place to support the phase II clinical trials that we have planned.
Again our lead product is Reolysin.
(Slide 6) This slide and on the left panel of this side you can see, the sort of schematic of how reovirus and Reolysin lyse cancer cells. Reolysin contains naturally occurring reovirus. This is replication competent virus; it's not genetically modified to carry any heterologous genes. Reovirus itself is asymptomatic in humans, although many people have been exposed to reovirus it doesn't cause disease generally, and part of the reason is that reovirus selectively replicates only in RAS activated cells. And it turns out that RAS activated cancers comprise about two thirds of all cancers, so it is very broad-based. We have estimated that at least 5 million new patients a year are going to develop cancers with RAS involvement and therefore would be targets for Reolysin therapy.
(Slide 7) This is sort of a quick and I have a couple of slides here to show you what happens when reovirus invades a non-RAS active cell vs. a RAS activated cell. Reovirus actually infects both normal and RAS active cells it is just unable to reproduce, to replicate in normal cells, such as this non-RAS active cell which schematically presented here. When RAS is inactive the active PKR prevents translation of the viral mRNA and the virus can't replicate.
(Slide 8) Whereas in a RAS activated cell. The RAS blocks PKR and the virus is able to replicate.
So that's the selective mode of action of Reovirus and Reolysin.
(Slide 9) Now, this slide is a depiction of the two modes of action that we believe Reolysin uses to inhibit tumour growth and regress tumours. Primary mode of action of course is that the reovirus selectively invades tumour cells, replicates, makes more virus particles, which go out and invade more tumour cells and cause lyses of the tumour. In addition, we believe and we have some evidence that I'll discuss a little later that would to lead us to believe that when these tumour cells lyse the tumour antigens are released and the immune system of the patient then is able to form antibodies against the tumour antigens. So that's thesecondary mode
of killing the tumour cells.
(Slide 10)Oncolytics Biotech has a very large intellectual property portfolio. We have over 150 issued patents worldwide. That includes a couple dozen in the US, six in Canada, we have issued patents in Europe, allowed claims in Japan. And with respect to our Reovirus patent portfolio those claims cover composition of matter, both of reovirus and reovirus in combination with other treatments, and also methods of treatments and methods of manufacturer.
In addition to our Reovirus IP portfolio, we have patents to other viruses which are oncolytic to RAS activated tumour. And we have issued patents directed to adenovirus and herpes virus therapies as well. These viruses are genetically engineered.
We have in addition to our 150 issued patents, we have more than 180 pending patent applications worldwide, and those patterns are in 30 families, very broad, and we continue to file new patent applications that cover our commercial products.
(Slide 11) Manufacturing of Reolysin was we believe a key factor in the success of the product and we are very proud of the success we've had there. Its obviously critical to be able to have products to use in our clinical trials and commercially and we have been able to successfully develop proprietary cell growth medium, and we have GNP material produced at the 20 liter scale and we just completed a 40 liter scale up which provided more than 20,000 doses of Reolysin at three 3x10 to the 10th TCID50 and that's per 40 liter run. So that's pretty good, we are at the hundred liter scale up work right now and we are comfortably able to provide virus for all of our ongoing and planned phase II clinical trials.
To give you an idea, I've been told that in the picture that's 9 L of the virus and if we were selling the virus at what we anticipate we will be selling it at, that's $50 to $100 million worth of virus in that glass.
(Slide 12) Reolysin as far as we know in all the studies that we have done, with over 130 patients, has a very good safety profile. These patients have received Reolysin either intratumourally, intracerebrally, or systemically IV at a doses of high as 3x10 to the 10th. And we have not reached the maximum tolerated dose to date. The toxicities that we have seen have generally been mild. The patients on our studies have described them by and large as pre-flu like symptoms. What it feel like when you are about to come down with the flu. They are reversible and we've been able to manage them with something like a Tylenol.
(Slide 13) This slide, which is a very busy slide, gives an overview of our clinical trial program, as of right now you can see that it's in four separate areas and I will be describing each of those as we go on.
(Slide 14) Okay, so there are really two branches in our clinical trial program. One is monotherapy and that is treating cancers with single agent, mainly Reolysin, without any co-therapies and the other arm is co-therapy.
In the single agent activity, in the monotherapy, again there are two branches: local delivery, intratumourally; and then systemic delivery, IV. The cotherapy which is what we believe is probably the anticipated way we are going to get to commercial use has again a local and systemic aspect to it. The local delivery being used intratumourally in conjunction with radiotherapy, and systemic delivery with systemic chemotherapy.
(Slide 15) Just to give you an idea, I know you probably can't read all the places on this map. But this is a map to show you how extensive our clinical trial sites are. They are all over the world: Asia, Europe, and the U.S. The orange dots are the sites that Oncolytics has trials going and the yellow dots are sites where we are plan to work with NCI on. So you can see that we have extensive clinical trials throughout the world.
(Slide 16) I'm going to tell you a little bit more about some of those. We have some results from a phase I/II intratumoural recurrent malignant glioma study that is currently enrolling in the phase I portion. This is a single product infusion, in other words, a single dose of Reolysin in patients with recurrent malignant glioma. This is a dose escalation study and then we expect that as we reach the MTD there will be a treatment arm. The product Reolysin is infusion delivered. It's not local, it’s systemic, and we have done three previous studies, phase I glioma studies, and one of those studies we have had 12 patients and six of those 12 patients actually lived more than six months, three of them lived longer than a year, and one patient (we believe) as far as we know is still alive. And certainly we know that the patient has survived longer than five years, so we were very heartened by those results.
(Slide 17) Another study that we are looking into is the phase IIa combination of Reolysin and radiotherapy. And this study is also going to focus on patients that have head/neck/oesophageal cancer. This will involve intratumoural administration of Reolysin with 20 Gy radiation and this will be in patients with advanced or metastatic solid tumours refractory to standard therapy. So we started enrollment in December of last year of the phase IIa study and the study is expected to be 40 patients with half of them in the head/neck/oesophageal cancer area. Part of the reason we designed the study the way did is that in preclinical studies we saw that there was a synergistic effect of radiation and Reolysin and we also had some clinical results in a phase Ia/Ib study that we did in the UK we were very excited, because even though we had local dosing of Reolysin, and of course we got local responses, we also got some remote responses, and the next couple slides will discuss that.
(Slide 18) This slide has three panels. It shows a patient who had supraclavicular lymph node cancer. This panel on the left is at the time of treatment. And you can see the tumour, which is shown in green, was quite enlarged, has moved to the esophagus, which is the dark space, aside. The patient was having trouble swallowing, etc. This middle panel is actually two months after the single course of treatment with intratumoural Reolysin and radiation. And by the way 20 Gy radiation is not curative but palliative, so you can see there was tumour regression and the esophagus was moving back into place. Most remarkably to our mind was the far right panel, which was taken seven months after the single course of treatment ,and you can see that tumour regression continues to occur and so there was clearly continued activity after there was no longer any reovirus in the body.
(Slide 19) And very excitingly, this is the same patient from the previous slide; we also saw a response outside the radiation field. This was a metastatic node in the same patient the panel of on the left is at the time a treatment panel the right to seven months later. So clearly either the reovirus was able to systemically be delivered to a remote cancer, this metastatic node and lyse the cancel cells there, or the secondary mode of action that I showed on the slide where the tumour antigens stimulated the body to mount an immune response against tumour antigens wherever they were found happened. So we got some remote response.
(Slide 20) Now systemic administration is really what we believe is going to be the largest potential patient population for Reolysin, and so many of our clinical trials are using systemic administration both in monotherapy and in combination therapy. So far in over 50 patients, systemic administration of Reolysin has been very well tolerated and we have two completed phase I studies, and that was found. In addition, we have had demonstrable tumour regression in a number of different cancer indications. So it's been very promising.
(Slide 21) We have some results from our phase I monotherapy with Reolysin can only systemic administration trials for both the UK and the US. In the UK we had the reovirus that was delivered IV. And was able to infect, stabilize, or regress tumours in a variety of different locations and tumour types. And in addition, we took tumour biopsies in some of the patients, and we were able to isolate live virus from the biopsy showing that systemic administration was able to deliver a virus to the tumour and the virus is able to replicate there.
In the phase I US results, we had 18 patients treated. And 8 of those 18 of those patients demonstrated stable disease or better including one partial response in a breast cancer patient. Again the toxicities related to treatment were very mild and very manageable.
(Slide 22) So this is a scan a CT scan from a patient in the UK study: Metastatic Prostate Cancer. You can see the two arrows in the left panel are taken pretreatment show enlarged lymph nodes to the left and to right of the bladder. You can see the color is very uniform. In contrast, if you look on the right side of the panel, if you look in the two arrows, there in the area of the lymph nodes (while there is some regression in size) you can see that the colors shows, there is necrosis of the tumour tissue. In addition to, and not shown on this slide, the PSA level in this patient went from about 100 pretreatment to 50 after Reolysin treatment.
(Slide 23) This is an electron micrograph of a tissue biopsy from the same patient and it's hard to tell because it's so close in, but there was widespread necrosis of the tumour tissue. So there was tumour cell death after Reolysin treatment systemically. In addition you can see by the arrows and the circled area that the virus is able to deliver to and infect the tumour cells and also that there was factory formation which is indicated by the circles. So the virus was able to not just infect him but replicate. As I said we did tumour biopsies and we were able to isolate up to 10 to the 7th infectious virus particles per gram of tumour tissue after the systemic administration.
(Slide 24) So, we are enrolling patients right now in a phase II sarcoma study. We are going to be treating those patients' IV with 3x10 to the 10th TCID50 for five days with re-treatment on a monthly basis. Enrollment has started. In addition, we have a couple other phase I/II monotherapy studies planned or in various stages. The phase II the melanoma study which will be done in conjunction with NCI should enroll 50 patients, and they'll have received Reolysin IV the protocol has to be submitted to the FDA for this study.
The phase I/II ovarian cancer clinical trial has been planned will enroll approximately 64 patients. This again will be done in conjunction with NCI and those patients will receive Reolysin both IV and IP.
(Slide 25) So right now we are also enrolling patients in three phase II systemic administration studies where Reolysin is being administered in combination with standard chemotherapeutics. And right now patients are being enrolled and you can see that we are using Reolysin in conjunction with docetaxel, paclitaxel, carboplatin, and gemcitabine. These drugs which are actually manufactured and sold by different companies have combined or have and had combined peak sales of about $7 billion per year. So we believe that if we can develop Reolysin and show how efficacious it is, how synergistic it is with these products. We'll really have a large market potential for Reolysin.
(Slide 26) Now part of the reason, and part of the rationale the kind of study design of these combination clinical studies was because we had evidence from preclinical studies that Reolysin was synergistic with a variety of different chemotherapeutic agents and a variety of cancers. This slide shows just how many chemotherapeutic has been tried with and been shown to be synergistic. You can see there is quite a range. Cisplatin, 5-FU, doxorubicin, docetaxel, and others. And this work has been done by collaborators all over the world with the same results. And the list of collaborators is also on this slide. And I want to point out that of course is synergistic with the common chemotherapeutic. But in addition, we have also shown that it's efficacious as a monotherapy all by itself.
(Slide 27) This slide presents some animal preclinical data that we're very excited about which is also a combination therapy. This slide, the study was done in mice with a human colon cancer cell line. The Green line on the top shows the tumour grows without any treatment, and then the red line shows treatments with Reolysin on its own. The Orange line is treatment with gemcitabine and the blue line down on the bottom is combined treatments with both Reolysin and gemcitabine and as you can see the tumour was completely cured...I'd hate to...you know...that's dicey to say, but we believe it really was, not just inhibited. But if you look at the right-hand arrows, the left hand arrow is the beginning of treatment, the right-hand arrows is the end of treatment and you can see that even days and days and days after treatment ended with these two agents there was no recurrence of tumours. This is very excited were looking forward to seeing the clinical trial results.
(Slide 28) This slide is just a general overview of our market and capital data. We are public company traded on both NASDAQ and the Toronto Stock exchange we have as of June 30th, 41 and 49-1/2 (approximately) million shares outstanding. As of June 30th we had 31-1/2 million dollars Canadian with a monthly burn rate of 1.4 million and that gives us cash well into 2009.
So in summary, we have found that Reolysin is a very broadly active novel cancer therapy, and we have engaged in and are continuing to progress through a focused clinical program. We have finished six clinical trials and have seven ongoing. And we expect that the enrollment will conclude in several of the phase II studies next year. And all of the interim and final data we have show that there are very positive results. We have a growing intellectual property portfolio with broad patent coverage all over the world, and especially in US, Europe and Canada. Solid balance sheets with enough funding to get us through our planned phase II clinical program. And we able to manufacture a product at commercial scale. So. Thank you very much, if anybody has any questions I will be upfront. Thank you.
BIO InvestorForum 2007
Ms. Mary Anne Dillahunty
Vice President, Intellectual Property
Oncolytics Biotech Inc.
October 11, 2007.
(Slide 1)Thank you. Good afternoon. Thank you for coming.
(Slide 2) I would like to draw your attention first of all to these forward-looking statements. We are a public company, so we are required to say this.
(Slide 3) Okay, Oncolytics' lead product is Reolysin which is a targeted anticancer therapy. It is a therapy based on a reovirus. And we have a broad-based phase II program, clinical trial program that is ongoing in the US and in the UK. In the clinical trials that we have done and we are doing, Reolysin has an excellent safety profile and its mechanism of action is actually directly cytotoxic in that we have seen tumour responses in a variety of cancers. With just single therapy with Reolysin itself, without any co-therapy. In addition, we have found that there are synergistic effects with the common chemotherapeutics and the conventional chemotherapies, and also with radiotherapy. Reolysin potentiates most cytotoxics that it has been tried in combination with. And we are now exploring that further with three combination trials that are enrolling patients.And addition it has been shown to synergistically potentiate radiotherapy, and we are also enrolling patients in a phase II combination radiotherapy and local Reolysin program.
(Slide 4) So, this slide just gives an overview of what I plan to talk about today. I'll tell you a little bit about the mode of action of Reolysin, something about our intellectual property portfolio, our manufacturing, and the safety of Reolysin, and then go into a little bit of detail on our clinical trial program.
(Slide 5) Oncolytics Biotech Inc. is a Calgary Alberta Canada based company whose corporate focus is on the development of Oncolytic viruses for the treatment of cancer. We have what we think is a comprehensive and ongoing clinical program with our lead product Reolysin. And in addition to having the program planned, we have the funding in place to support the phase II clinical trials that we have planned.Again our lead product is Reolysin.
(Slide 6) This slide and on the left panel of this side you can see, the sort of schematic of how reovirus and Reolysin lyse cancer cells. Reolysin contains naturally occurring reovirus. This is replication competent virus; it's not genetically modified to carry any heterologous genes. Reovirus itself is asymptomatic in humans, although many people have been exposed to reovirus it doesn't cause disease generally, and part of the reason is that reovirus selectively replicates only in RAS activated cells. And it turns out that RAS activated cancers comprise about two thirds of all cancers, so it is very broad-based. We have estimated that at least 5 million new patients a year are going to develop cancers with RAS involvement and therefore would be targets for Reolysin therapy.
(Slide 7) This is sort of a quick and I have a couple of slides here to show you what happens when reovirus invades a non-RAS active cell vs. a RAS activated cell. Reovirus actually infects both normal and RAS active cells it is just unable to reproduce, to replicate in normal cells, such as this non-RAS active cell which schematically presented here. When RAS is inactive the active PKR prevents translation of the viral mRNA and the virus can't replicate.
(Slide 8) Whereas in a RAS activated cell. The RAS blocks PKR and the virus is able to replicate.So that's the selective mode of action of Reovirus and Reolysin.
(Slide 9) Now, this slide is a depiction of the two modes of action that we believe Reolysin uses to inhibit tumour growth and regress tumours. Primary mode of action of course is that the reovirus selectively invades tumour cells, replicates, makes more virus particles, which go out and invade more tumour cells and cause lyses of the tumour. In addition, we believe and we have some evidence that I'll discuss a little later that would to lead us to believe that when these tumour cells lyse the tumour antigens are released and the immune system of the patient then is able to form antibodies against the tumour antigens. So that's thesecondary modeof killing the tumour cells.
(Slide 10)Oncolytics Biotech has a very large intellectual property portfolio. We have over 150 issued patents worldwide. That includes a couple dozen in the US, six in Canada, we have issued patents in Europe, allowed claims in Japan. And with respect to our Reovirus patent portfolio those claims cover composition of matter, both of reovirus and reovirus in combination with other treatments, and also methods of treatments and methods of manufacturer.In addition to our Reovirus IP portfolio, we have patents to other viruses which are oncolytic to RAS activated tumour. And we have issued patents directed to adenovirus and herpes virus therapies as well. These viruses are genetically engineered.
We have in addition to our 150 issued patents, we have more than 180 pending patent applications worldwide, and those patterns are in 30 families, very broad, and we continue to file new patent applications that cover our commercial products.
(Slide 11) Manufacturing of Reolysin was we believe a key factor in the success of the product and we are very proud of the success we've had there. Its obviously critical to be able to have products to use in our clinical trials and commercially and we have been able to successfully develop proprietary cell growth medium, and we have GNP material produced at the 20 liter scale and we just completed a 40 liter scale up which provided more than 20,000 doses of Reolysin at three 3x10 to the 10th TCID50 and that's per 40 liter run. So that's pretty good, we are at the hundred liter scale up work right now and we are comfortably able to provide virus for all of our ongoing and planned phase II clinical trials.To give you an idea, I've been told that in the picture that's 9 L of the virus and if we were selling the virus at what we anticipate we will be selling it at, that's $50 to $100 million worth of virus in that glass.
(Slide 12) Reolysin as far as we know in all the studies that we have done, with over 130 patients, has a very good safety profile. These patients have received Reolysin either intratumourally, intracerebrally, or systemically IV at a doses of high as 3x10 to the 10th. And we have not reached the maximum tolerated dose to date. The toxicities that we have seen have generally been mild. The patients on our studies have described them by and large as pre-flu like symptoms. What it feel like when you are about to come down with the flu. They are reversible and we've been able to manage them with something like a Tylenol.
(Slide 13) This slide, which is a very busy slide, gives an overview of our clinical trial program, as of right now you can see that it's in four separate areas and I will be describing each of those as we go on.
(Slide 14) Okay, so there are really two branches in our clinical trial program. One is monotherapy and that is treating cancers with single agent, mainly Reolysin, without any co-therapies and the other arm is co-therapy.In the single agent activity, in the monotherapy, again there are two branches: local delivery, intratumourally; and then systemic delivery, IV. The cotherapy which is what we believe is probably the anticipated way we are going to get to commercial use has again a local and systemic aspect to it. The local delivery being used intratumourally in conjunction with radiotherapy, and systemic delivery with systemic chemotherapy.
(Slide 15) Just to give you an idea, I know you probably can't read all the places on this map. But this is a map to show you how extensive our clinical trial sites are. They are all over the world: Asia, Europe, and the U.S. The orange dots are the sites that Oncolytics has trials going and the yellow dots are sites where we are plan to work with NCI on. So you can see that we have extensive clinical trials throughout the world.
(Slide 16) I'm going to tell you a little bit more about some of those. We have some results from a phase I/II intratumoural recurrent malignant glioma study that is currently enrolling in the phase I portion. This is a single product infusion, in other words, a single dose of Reolysin in patients with recurrent malignant glioma. This is a dose escalation study and then we expect that as we reach the MTD there will be a treatment arm. The product Reolysin is infusion delivered. It's not local, it’s systemic, and we have done three previous studies, phase I glioma studies, and one of those studies we have had 12 patients and six of those 12 patients actually lived more than six months, three of them lived longer than a year, and one patient (we believe) as far as we know is still alive. And certainly we know that the patient has survived longer than five years, so we were very heartened by those results.
(Slide 17) Another study that we are looking into is the phase IIa combination of Reolysin and radiotherapy. And this study is also going to focus on patients that have head/neck/oesophageal cancer. This will involve intratumoural administration of Reolysin with 20 Gy radiation and this will be in patients with advanced or metastatic solid tumours refractory to standard therapy. So we started enrollment in December of last year of the phase IIa study and the study is expected to be 40 patients with half of them in the head/neck/oesophageal cancer area. Part of the reason we designed the study the way did is that in preclinical studies we saw that there was a synergistic effect of radiation and Reolysin and we also had some clinical results in a phase Ia/Ib study that we did in the UK we were very excited, because even though we had local dosing of Reolysin, and of course we got local responses, we also got some remote responses, and the next couple slides will discuss that.
(Slide 18) This slide has three panels. It shows a patient who had supraclavicular lymph node cancer. This panel on the left is at the time of treatment. And you can see the tumour, which is shown in green, was quite enlarged, has moved to the esophagus, which is the dark space, aside. The patient was having trouble swallowing, etc. This middle panel is actually two months after the single course of treatment with intratumoural Reolysin and radiation. And by the way 20 Gy radiation is not curative but palliative, so you can see there was tumour regression and the esophagus was moving back into place. Most remarkably to our mind was the far right panel, which was taken seven months after the single course of treatment ,and you can see that tumour regression continues to occur and so there was clearly continued activity after there was no longer any reovirus in the body.
(Slide 19) And very excitingly, this is the same patient from the previous slide; we also saw a response outside the radiation field. This was a metastatic node in the same patient the panel of on the left is at the time a treatment panel the right to seven months later. So clearly either the reovirus was able to systemically be delivered to a remote cancer, this metastatic node and lyse the cancel cells there, or the secondary mode of action that I showed on the slide where the tumour antigens stimulated the body to mount an immune response against tumour antigens wherever they were found happened. So we got some remote response.
(Slide 20) Now systemic administration is really what we believe is going to be the largest potential patient population for Reolysin, and so many of our clinical trials are using systemic administration both in monotherapy and in combination therapy. So far in over 50 patients, systemic administration of Reolysin has been very well tolerated and we have two completed phase I studies, and that was found. In addition, we have had demonstrable tumour regression in a number of different cancer indications. So it's been very promising.
(Slide 21) We have some results from our phase I monotherapy with Reolysin can only systemic administration trials for both the UK and the US. In the UK we had the reovirus that was delivered IV. And was able to infect, stabilize, or regress tumours in a variety of different locations and tumour types. And in addition, we took tumour biopsies in some of the patients, and we were able to isolate live virus from the biopsy showing that systemic administration was able to deliver a virus to the tumour and the virus is able to replicate there.In the phase I US results, we had 18 patients treated. And 8 of those 18 of those patients demonstrated stable disease or better including one partial response in a breast cancer patient. Again the toxicities related to treatment were very mild and very manageable.
(Slide 22) So this is a scan a CT scan from a patient in the UK study: Metastatic Prostate Cancer. You can see the two arrows in the left panel are taken pretreatment show enlarged lymph nodes to the left and to right of the bladder. You can see the color is very uniform. In contrast, if you look on the right side of the panel, if you look in the two arrows, there in the area of the lymph nodes (while there is some regression in size) you can see that the colors shows, there is necrosis of the tumour tissue. In addition to, and not shown on this slide, the PSA level in this patient went from about 100 pretreatment to 50 after Reolysin treatment.
(Slide 23) This is an electron micrograph of a tissue biopsy from the same patient and it's hard to tell because it's so close in, but there was widespread necrosis of the tumour tissue. So there was tumour cell death after Reolysin treatment systemically. In addition you can see by the arrows and the circled area that the virus is able to deliver to and infect the tumour cells and also that there was factory formation which is indicated by the circles. So the virus was able to not just infect him but replicate. As I said we did tumour biopsies and we were able to isolate up to 10 to the 7th infectious virus particles per gram of tumour tissue after the systemic administration.
(Slide 24) So, we are enrolling patients right now in a phase II sarcoma study. We are going to be treating those patients' IV with 3x10 to the 10th TCID50 for five days with re-treatment on a monthly basis. Enrollment has started. In addition, we have a couple other phase I/II monotherapy studies planned or in various stages. The phase II the melanoma study which will be done in conjunction with NCI should enroll 50 patients, and they'll have received Reolysin IV the protocol has to be submitted to the FDA for this study.The phase I/II ovarian cancer clinical trial has been planned will enroll approximately 64 patients. This again will be done in conjunction with NCI and those patients will receive Reolysin both IV and IP.
(Slide 25) So right now we are also enrolling patients in three phase II systemic administration studies where Reolysin is being administered in combination with standard chemotherapeutics. And right now patients are being enrolled and you can see that we are using Reolysin in conjunction with docetaxel, paclitaxel, carboplatin, and gemcitabine. These drugs which are actually manufactured and sold by different companies have combined or have and had combined peak sales of about $7 billion per year. So we believe that if we can develop Reolysin and show how efficacious it is, how synergistic it is with these products. We'll really have a large market potential for Reolysin.
(Slide 26) Now part of the reason, and part of the rationale the kind of study design of these combination clinical studies was because we had evidence from preclinical studies that Reolysin was synergistic with a variety of different chemotherapeutic agents and a variety of cancers. This slide shows just how many chemotherapeutic has been tried with and been shown to be synergistic. You can see there is quite a range. Cisplatin, 5-FU, doxorubicin, docetaxel, and others. And this work has been done by collaborators all over the world with the same results. And the list of collaborators is also on this slide. And I want to point out that of course is synergistic with the common chemotherapeutic. But in addition, we have also shown that it's efficacious as a monotherapy all by itself.
(Slide 27) This slide presents some animal preclinical data that we're very excited about which is also a combination therapy. This slide, the study was done in mice with a human colon cancer cell line. The Green line on the top shows the tumour grows without any treatment, and then the red line shows treatments with Reolysin on its own. The Orange line is treatment with gemcitabine and the blue line down on the bottom is combined treatments with both Reolysin and gemcitabine and as you can see the tumour was completely cured...I'd hate to...you know...that's dicey to say, but we believe it really was, not just inhibited. But if you look at the right-hand arrows, the left hand arrow is the beginning of treatment, the right-hand arrows is the end of treatment and you can see that even days and days and days after treatment ended with these two agents there was no recurrence of tumours. This is very excited were looking forward to seeing the clinical trial results.
(Slide 28) This slide is just a general overview of our market and capital data. We are public company traded on both NASDAQ and the Toronto Stock exchange we have as of June 30th, 41 and 49-1/2 (approximately) million shares outstanding. As of June 30th we had 31-1/2 million dollars Canadian with a monthly burn rate of 1.4 million and that gives us cash well into 2009.
So in summary, we have found that Reolysin is a very broadly active novel cancer therapy, and we have engaged in and are continuing to progress through a focused clinical program. We have finished six clinical trials and have seven ongoing. And we expect that the enrollment will conclude in several of the phase II studies next year. And all of the interim and final data we have show that there are very positive results. We have a growing intellectual property portfolio with broad patent coverage all over the world, and especially in US, Europe and Canada. Solid balance sheets with enough funding to get us through our planned phase II clinical program. And we able to manufacture a product at commercial scale. So. Thank you very much, if anybody has any questions I will be upfront. Thank you.
Monday, October 15, 2007
Ottawa family donates $1M to help find cure for cancer
Regional facility hopes to attract top minds
By William Lin
The Ottawa Citizen
Monday, October 15, 2007
An Ottawa family has donated $1 million to the Ottawa Regional Cancer Foundation, a windfall it hopes will help attract three leading researchers and advance the testing of cancer-killing viruses.
The money will streamline clinical trials for a cutting-edge cancer therapy using oncolytic viruses, which attack cancer cells, but leave healthy ones alone, said John Bell, a senior scientist at the Ottawa Health Research Institute's Centre for Cancer Therapeutics.
It will also help attract three researchers -- from Montreal, Florida and Finland -- to Ottawa, Mr. Bell said.
The funding announcement is to be made this afternoon by the foundation.
"One of the things we're trying to do is provide them with access to funds so that the lack of money doesn't end up bottlenecking the work that they're doing," said Linda Eagen, president and CEO of the foundation, which acts as a conduit for cancer-related fundraising and donations.
The Ottawa family, at this point, wishes to remain anonymous, Ms. Eagen said.
"They're not flashy with their wealth," Mr. Bell said.
"They're very humble people. I think they like the idea that they can contribute to an innovative new therapy that can actually have a chance to make a big impact on society."
Ms. Eagen called the anonymous donors "visionary."
"It's the calibre of research that has been done here locally that was of interest to them and, in particular, John's potential in moving closer to a cure," she said.
The promising aspect of the cancer therapy is that the oncolytic viruses will attack tumours, but leave normal tissues alone, unlike many existing conventional treatments, Mr. Bell said.
"(With) many other kinds of conventional cancer therapy, the therapy attacks not only the tumour, but also the normal tissues. And that's why it gets to the point where we can't treat patients anymore, because it becomes too toxic," he said.
Evidence also suggests the viruses could stimulate a person's immune system, allowing it to battle the cancer as well, Mr. Bell added.
Until now, testing has almost all been done on animals, although a few trials have been made on patients. The donation will help push testing further to clinical trials, hopefully starting by early 2008, Mr. Bell said.
One researcher they plan to bring to Ottawa is Markus Vaha-Koskela of Finland, who has looked at an understudied virus that targets brain cancer, Mr. Bell said.
"I was quite excited to bring him over, but I didn't have a way to do it, and now this will pave the way for that to happen," Mr. Bell said.
The other two researchers are Marianne Stanford from Florida, who has studied the myxoma virus, part of the family of viruses that they plan to test next year, and Jean-Simon Diallo from Montreal, according to Mr. Bell.
"It's quite an honour to receive something like this," Mr. Bell said. "What I think is really special about this donation is that (the donors) said, 'We want something really innovative done with this money,' not just carrying on with the 'same old, same old.' So we feel a real responsibility that we use it wisely."
Although there are several teams in the United States and Europe working on similar research, this donation will help OHRI's Centre for Cancer Therapeutics "keep at the front of the herd," Mr. Bell said.
"He is just an amazing scientist and at the verge (of making) a big difference in opportunities to cure cancer," Ms. Eagen said of the senior scientist, adding that the foundation has supported Mr. Bell's work for years.
In the last three years, the foundation increasingly saw more donors give six- and seven-figure gifts, Ms. Eagen said.
Although Mr. Bell hesitates to tout the oncolytic viral therapy as a cure for cancer, that's their ultimate goal.
"We have our dreams and hopes, but at this time, until we do more testing on people, we can't say for sure what it's going to be."
But he added: "I feel there's enough information to say that this is going to have an important change in the way cancer is treated. I could potentially improve the outcomes for patients."
They hope that one day, with enough research, cancer patients can be told they have a 100-per-cent survival rate.
"Then we're out of business. And you know what? I would just be delighted to look for another job," Ms. Eagen said.
Posted from here
By William Lin
The Ottawa Citizen
Monday, October 15, 2007
An Ottawa family has donated $1 million to the Ottawa Regional Cancer Foundation, a windfall it hopes will help attract three leading researchers and advance the testing of cancer-killing viruses.
The money will streamline clinical trials for a cutting-edge cancer therapy using oncolytic viruses, which attack cancer cells, but leave healthy ones alone, said John Bell, a senior scientist at the Ottawa Health Research Institute's Centre for Cancer Therapeutics.
It will also help attract three researchers -- from Montreal, Florida and Finland -- to Ottawa, Mr. Bell said.
The funding announcement is to be made this afternoon by the foundation.
"One of the things we're trying to do is provide them with access to funds so that the lack of money doesn't end up bottlenecking the work that they're doing," said Linda Eagen, president and CEO of the foundation, which acts as a conduit for cancer-related fundraising and donations.
The Ottawa family, at this point, wishes to remain anonymous, Ms. Eagen said.
"They're not flashy with their wealth," Mr. Bell said.
"They're very humble people. I think they like the idea that they can contribute to an innovative new therapy that can actually have a chance to make a big impact on society."
Ms. Eagen called the anonymous donors "visionary."
"It's the calibre of research that has been done here locally that was of interest to them and, in particular, John's potential in moving closer to a cure," she said.
The promising aspect of the cancer therapy is that the oncolytic viruses will attack tumours, but leave normal tissues alone, unlike many existing conventional treatments, Mr. Bell said.
"(With) many other kinds of conventional cancer therapy, the therapy attacks not only the tumour, but also the normal tissues. And that's why it gets to the point where we can't treat patients anymore, because it becomes too toxic," he said.
Evidence also suggests the viruses could stimulate a person's immune system, allowing it to battle the cancer as well, Mr. Bell added.
Until now, testing has almost all been done on animals, although a few trials have been made on patients. The donation will help push testing further to clinical trials, hopefully starting by early 2008, Mr. Bell said.
One researcher they plan to bring to Ottawa is Markus Vaha-Koskela of Finland, who has looked at an understudied virus that targets brain cancer, Mr. Bell said.
"I was quite excited to bring him over, but I didn't have a way to do it, and now this will pave the way for that to happen," Mr. Bell said.
The other two researchers are Marianne Stanford from Florida, who has studied the myxoma virus, part of the family of viruses that they plan to test next year, and Jean-Simon Diallo from Montreal, according to Mr. Bell.
"It's quite an honour to receive something like this," Mr. Bell said. "What I think is really special about this donation is that (the donors) said, 'We want something really innovative done with this money,' not just carrying on with the 'same old, same old.' So we feel a real responsibility that we use it wisely."
Although there are several teams in the United States and Europe working on similar research, this donation will help OHRI's Centre for Cancer Therapeutics "keep at the front of the herd," Mr. Bell said.
"He is just an amazing scientist and at the verge (of making) a big difference in opportunities to cure cancer," Ms. Eagen said of the senior scientist, adding that the foundation has supported Mr. Bell's work for years.
In the last three years, the foundation increasingly saw more donors give six- and seven-figure gifts, Ms. Eagen said.
Although Mr. Bell hesitates to tout the oncolytic viral therapy as a cure for cancer, that's their ultimate goal.
"We have our dreams and hopes, but at this time, until we do more testing on people, we can't say for sure what it's going to be."
But he added: "I feel there's enough information to say that this is going to have an important change in the way cancer is treated. I could potentially improve the outcomes for patients."
They hope that one day, with enough research, cancer patients can be told they have a 100-per-cent survival rate.
"Then we're out of business. And you know what? I would just be delighted to look for another job," Ms. Eagen said.
Posted from here
Thanks everybody for visiting my site. I am more than just a little surprised to see how many people stop by everyday. By the report that I receive, Oncolytics.blogspot.com is one of my most popular blogs, and I guess there's a lot more interest in Oncolytics than I thought. I was away for most of last week, which turned out to be an interesting one for ONCY. We saw some significant volume spikes, which leads one to think that we should be getting some news shortly. As I said, I was away last week and thus unable to prepare anything new for the page. Hopefully I'll have something new in the next couple days.
Here is an article not related to Oncolytics, but nonetheless newsworthy.
Cancer death rates are dropping faster than ever
oncy.man
Here is an article not related to Oncolytics, but nonetheless newsworthy.
Cancer death rates are dropping faster than ever
oncy.man
Monday, October 8, 2007
Interesting Article
Another old article, but some might have missed it before due to bizjournals subscription requirements.
Friday, September 21, 2007
Twice so far, Kenneth Scott has had something most people try to avoid injected into his veins -- a virus.
But while the virus gives Scott a headache, a stomach ache, fever and chills for a few days, it offers him some hope that it will stabilize or shrink the tumors in his lung.
"I think the possibility of this drug is really amazing," says Scott, a 51-year-old Big Springs resident. "We were pretty excited about it. Our faith is in God. We really believe what happens is going to be for the best."
The viral agent, a reovirus formulated by Calgary, Alberta-based Oncolytics Biotech Inc., is the first virus to undergo a clinical trial at the Cancer Therapy and Research Center's Institute for Drug Development. And for its director, Dr. Frank Giles, it too offers excitement. It puts the research facility on the road to testing a new wave of potential treatments in the field of oncology -- viruses
Find more information about the Institute for Drug Development here.
Thursday, October 4, 2007
Oncolytics Biotech Inc. to Present at BIO InvestorForum 2007
CALGARY, AB, October 4, 2007 --- Ms. Mary Ann Dillahunty, Vice President, Intellectual Property of Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY), will present a corporate overview of the Company at BIO InvestorForum 2007 on Thursday, October 11 at 12 p.m. PT. The conference will be held at the Palace Hotel in San Francisco from October 9-11, 2007. A live audio link to the webcast presentation is available on the company’s website at www.oncolyticsbiotech.com.
It is recommended that listeners log on 15 minutes in advance of the presentation to register and download any necessary software.
The BIO InvestorForum explores investment trends and opportunities in life sciences, with a focus on public and venture-stage growth companies as well as those poised to join the growth “watch list” in 2008. With a target audience of public and private equity investors, research analysts, investment bankers and senior-level industry executives focused on investment trends and business development opportunities in life sciences.
Find more information here
It is recommended that listeners log on 15 minutes in advance of the presentation to register and download any necessary software.
The BIO InvestorForum explores investment trends and opportunities in life sciences, with a focus on public and venture-stage growth companies as well as those poised to join the growth “watch list” in 2008. With a target audience of public and private equity investors, research analysts, investment bankers and senior-level industry executives focused on investment trends and business development opportunities in life sciences.
Find more information here
Wednesday, October 3, 2007
Oncolytics Biotech Inc. to Present at BioPartnering Europe
CALGARY, AB, October 3, 2007 --- Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY), will present a corporate overview of the Company at the 15th annual BioPartnering Europe conference in London, U.K. on Tuesday, October 9 at 9 a.m. The conference will be held at the Queen Elizabeth II Conference Centre from October 7-9, 2007.
See the full release here.
BioPartnering Europe began as a partnership between the U.S. Commercial Service and Technology Vision Group LLC to bring about closer ties between American and European biotechnology companies. Each year BioPartnering Europe showcases a number of young companies from North America, Europe and other parts of the world based on the recommendation of leading bioinvestors. This year 30 companies will offer a 14-minute podium presentation in the main plenary hall. Each company will then be available for private meetings directly afterwards. In the past, BPE has featured many young companies that have gone on to become the industry's most important players.
See the list of presenters here
See the full release here.
BioPartnering Europe began as a partnership between the U.S. Commercial Service and Technology Vision Group LLC to bring about closer ties between American and European biotechnology companies. Each year BioPartnering Europe showcases a number of young companies from North America, Europe and other parts of the world based on the recommendation of leading bioinvestors. This year 30 companies will offer a 14-minute podium presentation in the main plenary hall. Each company will then be available for private meetings directly afterwards. In the past, BPE has featured many young companies that have gone on to become the industry's most important players.
See the list of presenters here
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