CALGARY, AB, --- August 12, 2008 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that the U.S. National Cancer Institute (NCI), part of the National Institutes of Health, has started enrolment in a Phase 2 clinical trial for patients with metastatic melanoma using systemic administration of REOLYSIN®, Oncolytics’ proprietary formulation of the human reovirus. The trial is being carried out by the Mayo Phase 2 Consortium under the NCI’s Clinical Trials Agreement with Oncolytics, while Oncolytics will provide clinical supplies of Reolysin®. The Principal Investigator is Dr. Evanthia Galanis of the Mayo Clinic Cancer Center.
The primary objectives of the study are to assess the antitumour effects of Reolysin® in patients with metastatic malignant melanoma, as well as the safety profile of Reolysin®. Secondary objectives include assessment of progression free survival and overall survival.
Patients will receive systemic administration of REOLYSIN® at a dose of 3x10(10) TCID(50) per day on days 1-5 of each 28 day cycle, and patients may receive up to 12 cycles of treatment. The trial is expected to enroll up to 47 patients with metastatic melanoma.
Approximately 60,000 people are diagnosed with melanoma in the U.S. every year.
Tuesday, August 12, 2008
Wednesday, July 30, 2008
Oncolytics Biotech Inc. Announces 2008 Second Quarter Results
CALGARY, July 29 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced its financial results and highlights for the three and six month periods ended June 30, 2008.
"Oncolytics experienced a strong second quarter with the reporting of durable clinical responses to REOLYSIN® combination therapy treatment in refractory head and neck cancer patients," said Dr. Brad Thompson, President and CEO of Oncolytics. "We are enrolling increasing numbers of patients in our clinical program for REOLYSIN®, and the positive results from these trials are helping us to plan the later-stage development program for REOLYSIN®."
"Oncolytics experienced a strong second quarter with the reporting of durable clinical responses to REOLYSIN® combination therapy treatment in refractory head and neck cancer patients," said Dr. Brad Thompson, President and CEO of Oncolytics. "We are enrolling increasing numbers of patients in our clinical program for REOLYSIN®, and the positive results from these trials are helping us to plan the later-stage development program for REOLYSIN®."
Second Quarter Highlights
Significant Clinical Advances
- Presented positive interim U.S. Phase II sarcoma trial results at the
American Society of Clinical Oncology (ASCO) annual meeting, showing 8
of 16 evaluable patients experienced stable disease for periods
ranging from two to more than ten, 28-day cycles.
- Presented positive interim results from a U.K. combination REOLYSIN®
and paclitaxel/carboplatin trial at the British Society of Gene
Therapy (BSGT) conference in Edinburgh. Three head and neck patients
evaluated at that time had excellent clinical and radiological
responses without appreciable toxicity. The dose escalation portion of
this trial was completed in the second quarter.
- Received approval for U.K. and U.S. Phase II clinical trials
investigating REOLYSIN® in combination with paclitaxel and
carboplatin, and started patient enrolment in the U.K. trial.
- The U.S. National Cancer Institute started patient enrolment in a
Phase I/II ovarian, peritoneal and fallopian tube cancer trial using
systemic and intraperitoneal administration of REOLYSIN®.
- Started patient enrolment in a U.K. combination REOLYSIN® and
cyclophosphamide trial.
- Subsequent to the quarter end, announced that the 200th patient had
been treated with REOLYSIN®.
Preclinical Advances
- Two presentations were delivered at the American Society of Gene
Therapy (ASGT) meeting covering work using the reovirus against
mesothelioma, and also to purge lymph nodes of tumor cells.
- Another two presentations were delivered at the American Association
for Cancer Research (AACR) covering work using the reovirus in
combination with radiation for pediatric sarcomas, and reovirus as a
purging agent for autologous stem cell transplants.
- A paper covering preclinical work demonstrating that reovirus can kill
melanoma cell lines and freshly resected tumour was published in Gene
Therapy.
- A paper covering preclinical work demonstrating that reovirus can
activate dendritic cells to promote innate, antitumor immunity was
published in the Journal of Immunology.
Manufacturing
- Successfully transferred cGMP production of REOLYSIN® at the
40-litre batch size to SAFC Pharma(TM), a Division of Sigma-Aldrich
Corporation. Yields at the 40-litre scale should provide sufficient
doses to support future development plans leading to registration and
also early-stage commercial requirements. Development work at the 100-
litre scale is continuing.
Intellectual Property
- One U.S. patent and one Canadian patent were secured in the second
quarter. Oncolytics has secured more than 180 patents worldwide,
including 27 U.S. patents and 9 Canadian patents.
For the entire text, please go here
Thursday, July 17, 2008
Oncolytics Biotech Inc. Treats 200th Cancer Patient in Clinical Studies with Reolysin
Ok, so this is a few days late, but I think most of you should have known about this already.
Monday July 14, 4:22 pm ET
- Company to Host Conference Call to Update Clinical Program -CALGARY, July 14
Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that it has now enrolled and treated 200 cancer patients in clinical studies with Reolysin®, its proprietary formulation of the human reovirus.
"The clinical program has gained substantial momentum in the past year, culminating in the treatment of our 200th patient this week," said Dr. Brad Thompson, President and CEO of Oncolytics. "Reolysin® has been well tolerated by the patients, and has demonstrated activity in all trials reported on to date. Our current studies will allow us to design our pivotal program based on Phase II data from human clinical studies."
Together with its collaborators, Oncolytics is now recruiting or enrolling patients in ten Phase I/II or Phase II clinical trials with Reolysin® in the U.S. and the U.K., and has permission to begin another Phase II trial in the U.S. These trials include four monotherapy trials using REOLYSIN® alone, and seven trials using Reolysin® in combination with radiation or chemotherapy.
Conference Call Details
Dr. Brad Thompson, President and CEO of Oncolytics, will host a conference call on Wednesday, July 16, 2008 at 11:30 a.m. MST (1:30 p.m. EST) to update investors on the Company's current and future clinical program for Reolysin®.
Tuesday, June 24, 2008
Article: In cancer war, viruses can be good guys
Interesting article worth checking out from McClatchy Newspapers.
Viruses aren't always the bad guys. Sure, they can cause colds, measles, AIDS and other miseries. But with some tinkering, these tiny organisms may become a new and better way to treat cancer.
...researchers are working with a harmless virus that sits in the lungs and intestines of most people. It's called a "reovirus," short for respiratory enteric orphaned virus. A Canadian company, Oncolytics Biotech, fiddles with reovirus genes to produce Reolysin, a virus that attacks a wide variety of cancers.
Read the full article here.
Viruses aren't always the bad guys. Sure, they can cause colds, measles, AIDS and other miseries. But with some tinkering, these tiny organisms may become a new and better way to treat cancer.
...researchers are working with a harmless virus that sits in the lungs and intestines of most people. It's called a "reovirus," short for respiratory enteric orphaned virus. A Canadian company, Oncolytics Biotech, fiddles with reovirus genes to produce Reolysin, a virus that attacks a wide variety of cancers.
Read the full article here.
Thursday, June 19, 2008
Oncolytics Biotech Inc. Announces U.S. Phase 2 Clinical Trial Investigating Reolysin in Combination with Paclitaxel and Carboplatin
CALGARY, June 20 - Oncolytics Biotech Inc. ("Oncolytics") announced today that following U.S. Food and Drug Administration (FDA) review, the Company is initiating a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers. The Principal Investigator is Dr. Monica Mita of the Cancer Therapy and Research Center, University of Texas Health Science Center in San Antonio, Texas (CTRC at UTHSCSA).
"REOLYSIN® is one of the more exciting targeted agents under development in oncology," said Dr. Frank Giles, Director of the Institute for Drug Development. "Our investigators within the CTRC at UTHSCSA are very excited to begin studying potential synergy with standard cytotoxic agents and are eager to expand our studies into other tumor types and utilizing other chemotherapy partner regimens."
This trial is a 14-patient, single arm, open-label, dose-targeted, non-randomized trial of REOLYSIN® given intravenously in combination with a standard dosage of paclitaxel and carboplatin.
Eligible patients include those with advanced or metastatic head and neck cancers that are refractory to standard therapy or for which no curative standard therapy exists. The primary objective of the Phase 2 trial is to measure tumour responses and duration of response, and to describe any evidence of antitumour activity. The secondary objective is to determine the safety and tolerability of REOLYSIN® when administered in combination with paclitaxel and carboplatin to patients with advanced or metastatic head and neck cancers.
"REOLYSIN® is one of the more exciting targeted agents under development in oncology," said Dr. Frank Giles, Director of the Institute for Drug Development. "Our investigators within the CTRC at UTHSCSA are very excited to begin studying potential synergy with standard cytotoxic agents and are eager to expand our studies into other tumor types and utilizing other chemotherapy partner regimens."
This trial is a 14-patient, single arm, open-label, dose-targeted, non-randomized trial of REOLYSIN® given intravenously in combination with a standard dosage of paclitaxel and carboplatin.
Eligible patients include those with advanced or metastatic head and neck cancers that are refractory to standard therapy or for which no curative standard therapy exists. The primary objective of the Phase 2 trial is to measure tumour responses and duration of response, and to describe any evidence of antitumour activity. The secondary objective is to determine the safety and tolerability of REOLYSIN® when administered in combination with paclitaxel and carboplatin to patients with advanced or metastatic head and neck cancers.
Thursday, June 12, 2008
Oncolytics Biotech Inc. to Present at BIO 2008 International Convention
CALGARY, June 12 - Oncolytics Biotech Inc., announced today that Dr. Brad Thompson, President and CEO of Oncolytics, will participate in two separate presentations at the BIO 2008 International Convention.
Dr. Thompson is scheduled to provide a corporate overview of the Company on Tuesday, June 17th at 3:30 p.m. PT at the BIO Business Forum.
On Wednesday, June 18th at 4:00 p.m. PT, Dr. Thompson is also scheduled to participate as an invited speaker as part of a panel discussion entitled "Canada: Your Global Partner for Cancer Research Innovation."
The Conference, which is expected to draw approximately 20,000 attendees, will be held at the San Diego Convention Center June 17th to June 20th, 2008.
Dr. Thompson is scheduled to provide a corporate overview of the Company on Tuesday, June 17th at 3:30 p.m. PT at the BIO Business Forum.
On Wednesday, June 18th at 4:00 p.m. PT, Dr. Thompson is also scheduled to participate as an invited speaker as part of a panel discussion entitled "Canada: Your Global Partner for Cancer Research Innovation."
The Conference, which is expected to draw approximately 20,000 attendees, will be held at the San Diego Convention Center June 17th to June 20th, 2008.
Tuesday, June 10, 2008
Oncolytics Biotech Inc. Announces Start of Enrolment in Phase 1/2 Ovarian Cancer Clinical Trial with Reolysin
CALGARY, June 10 - Oncolytics Biotech Inc. ("Oncolytics") announced today that patient enrolment has started in a Phase 1/2 clinical trial for patients with metastatic ovarian, peritoneal and fallopian tube cancers using concurrent intravenous (IV) and intraperitoneal (IP) administration of REOLYSIN®, Oncolytics' proprietary formulation of the human reovirus. The National Cancer Institute (NCI), part of the National Institutes of Health, is sponsoring the trial under its Clinical Trials Agreement with Oncolytics, while Oncolytics will provide clinical supplies of REOLYSIN®. The Principal Investigator is Dr. David E. Cohn, Associate Professor, Division of Gynecologic Oncology at The Ohio State University College of Medicine in Columbus, Ohio.
"REOLYSIN® is an exciting agent to investigate in patients with ovarian cancer," said Dr. Cohn. "Targeting a specific alteration commonly present in these tumors will hopefully lead to efficacy with minimal toxicity."
"We are looking forward to working closely with the NCI to examine the effects of using REOLYSIN® with two concurrent methods of administration," said Dr. Brad Thompson, President and CEO of Oncolytics. "Our REOLYSIN® clinical program has now expanded to include ten Phase 1/2 or Phase 2 trials in the U.S. and the U.K. using REOLYSIN® as a monotherapy or in combination with radiation or chemotherapy."
In the Phase 1 portion of the trial, patients will receive a constant dose of IV REOLYSIN® on days 1-5 every 28 days, as well as an escalating dose of IP REOLYSIN® on days 1-2 every 28 days. In the Phase 2 portion of the study, patients will receive a constant dose of IV REOLYSIN® on days 1-5 every 28 days as well as the Maximum Tolerated Dose (MTD) of IP REOLYSIN® from the Phase 1 portion.
The primary objectives of the Phase 1 trial are to determine the safety and tolerability of intravenous and intraperitoneal administration of REOLYSIN®, and the MTD of IP REOLYSIN® when used with a fixed dose of IV REOLYSIN®. The primary objective of the Phase 2 trial is to determine the objective response rate of treatment with IV and IP REOLYSIN® in patients with recurrent, platinum-refractory ovarian, peritoneal and tubal carcinomas. The Phase 1/2 trial is expected to enroll up to 70 patients.
The American Cancer Society estimates that more than 22,000 women will be diagnosed with ovarian cancer in the U.S. in 2008, and more than 15,000 will die from it.
"REOLYSIN® is an exciting agent to investigate in patients with ovarian cancer," said Dr. Cohn. "Targeting a specific alteration commonly present in these tumors will hopefully lead to efficacy with minimal toxicity."
"We are looking forward to working closely with the NCI to examine the effects of using REOLYSIN® with two concurrent methods of administration," said Dr. Brad Thompson, President and CEO of Oncolytics. "Our REOLYSIN® clinical program has now expanded to include ten Phase 1/2 or Phase 2 trials in the U.S. and the U.K. using REOLYSIN® as a monotherapy or in combination with radiation or chemotherapy."
In the Phase 1 portion of the trial, patients will receive a constant dose of IV REOLYSIN® on days 1-5 every 28 days, as well as an escalating dose of IP REOLYSIN® on days 1-2 every 28 days. In the Phase 2 portion of the study, patients will receive a constant dose of IV REOLYSIN® on days 1-5 every 28 days as well as the Maximum Tolerated Dose (MTD) of IP REOLYSIN® from the Phase 1 portion.
The primary objectives of the Phase 1 trial are to determine the safety and tolerability of intravenous and intraperitoneal administration of REOLYSIN®, and the MTD of IP REOLYSIN® when used with a fixed dose of IV REOLYSIN®. The primary objective of the Phase 2 trial is to determine the objective response rate of treatment with IV and IP REOLYSIN® in patients with recurrent, platinum-refractory ovarian, peritoneal and tubal carcinomas. The Phase 1/2 trial is expected to enroll up to 70 patients.
The American Cancer Society estimates that more than 22,000 women will be diagnosed with ovarian cancer in the U.S. in 2008, and more than 15,000 will die from it.
Monday, June 9, 2008
Oncolytics Biotech, Inc. Files Form F-10
Oncolytics Biotech, Inc. filed Form F-10 with the United States Securities and Exchange Commision. See the text here.
Oncolytics Biotech Starts Patient Enrolment in U.K. Phase II Clinical Trial Investigating Reolysin in Combination With Paclitaxel and Carboplatin
CALGARY, Canada, June 5 -- Oncolytics Biotech Inc. ("Oncolytics") announced today that that it has started patient enrolment in a Phase II clinical trial using intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers. The principal investigator is Dr. Kevin Harrington of The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust. This trial is a 14-patient, single arm, open-label, dose-targeted, non-randomized trial of REOLYSIN® given intravenously in combination with a standard dosage of paclitaxel and carboplatin. Eligible patients include those with advanced or metastatic head and neck cancers that are refractory to standard therapy or for which no curative standard therapy exists. The primary objective of the Phase II trial is to measure tumour responses and duration of response, and to describe any evidence of antitumour activity. The secondary objective is to determine the safety and tolerability of REOLYSIN® when administered in combination with paclitaxel and carboplatin to patients with advanced or metastatic head and neck cancer.
Monday, June 2, 2008
Oncolytics Biotech Inc. Collaborators Present Positive Phase II Sarcoma Trial Results at ASCO Annual Meeting
CALGARY, Canada, June 2/Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) announced that interim results of a Phase II study of intravenous REOLYSIN® in patients with sarcomas metastatic to the lung were presented yesterday at the American Society of Clinical Oncology (ASCO) annual meeting. The presentation, entitled "A Phase II Study of Intravenous REOLYSIN (Wild-type Reovirus) in the Treatment of Patients with Bone and Soft Tissue Sarcomas Metastatic to the Lung" was delivered by Dr. Monica Mita, the study principal investigator and her team at the Institute of Drug Development (IDD), the Cancer Therapy and Research Center at the University of Texas Health Science Center, (UTHSC), San Antonio, Texas.
The interim results demonstrate that the treatment has been well tolerated to date, with 8 of 16 evaluable patients experiencing stable disease for periods ranging from two to more than ten, 28-day cycles. As previously announced by Oncolytics, the third patient treated in the study was demonstrated to have stable disease by RECIST criteria for more than six months as measured by CT scan. A PET scan taken at the same time showed that any residual mass was metabolically inert.
"These very encouraging data have increased our commitment to the thorough investigation of this exciting, unique, truly targeted agent," said Dr Francis Giles, Director of the IDD at UTHSC.
"We feel privileged to participate in this study and to be able to offer this therapeutic option to our patients," said Dr. Mita. "Patients have tolerated the treatment well and seem to have disease control up to several months, which is encouraging for patients with advanced refractory sarcoma." A copy of the poster will be available on the Oncolytics' website today.
The interim results demonstrate that the treatment has been well tolerated to date, with 8 of 16 evaluable patients experiencing stable disease for periods ranging from two to more than ten, 28-day cycles. As previously announced by Oncolytics, the third patient treated in the study was demonstrated to have stable disease by RECIST criteria for more than six months as measured by CT scan. A PET scan taken at the same time showed that any residual mass was metabolically inert.
"These very encouraging data have increased our commitment to the thorough investigation of this exciting, unique, truly targeted agent," said Dr Francis Giles, Director of the IDD at UTHSC.
"We feel privileged to participate in this study and to be able to offer this therapeutic option to our patients," said Dr. Mita. "Patients have tolerated the treatment well and seem to have disease control up to several months, which is encouraging for patients with advanced refractory sarcoma." A copy of the poster will be available on the Oncolytics' website today.
Wednesday, May 28, 2008
Oncolytics Biotech Inc. to Present at Gene Therapy and Vaccines Symposium
CALGARY, May 26/Dr. Matt Coffey, Chief Scientific Officer of Oncolytics Biotech Inc. will present an update on the clinical development of Reolysin at the 4th Canadian Gene Therapy and Vaccines Symposium on Tuesday, May 27 at 10:00 a.m. (ET). The symposium is being held at the National Research Council's Biotechnology Research Institute in Montreal, Quebec on May 26th and 27th, 2008.
Oncolytics Biotech Inc. Announces Issuance of 9th Canadian Patent
CALGARY, May 23/Oncolytics Biotech Inc. today announced it has been granted Canadian Patent 2,360,833 entitled "Reovirus for the Treatment of Cellular Proliferative Disorders." The claims describe the use of one or more recombinant reoviruses to treat Ras-mediated proliferative disorders.
"This patent provides the Company with additional patent protection for the use of reovirus compositions for cancers and other cellular proliferative disorders in Canada," said Mary Ann Dillahunty, Vice President of Intellectual Property for Oncolytics.
"This patent provides the Company with additional patent protection for the use of reovirus compositions for cancers and other cellular proliferative disorders in Canada," said Mary Ann Dillahunty, Vice President of Intellectual Property for Oncolytics.
Oncolytics Biotech Inc. Transfers 40-Litre cGMP Manufacturing Process for Reolysin
CALGARY, May 22/Oncolytics Biotech Inc. announced today that it has successfully transferred cGMP production for REOLYSIN® at the 40-litre batch size to SAFC Pharma(TM), a Division of Sigma-Aldrich Corporation. This follows the successful scale-up from 20 litres to 40 litres announced by the Company last year.
Yields at the 40-litre scale should provide sufficient doses to support future development plans leading to registration and also anticipated early stage commercial requirements. Development work to support further scale-up to the 100-litre level is currently underway.
"Manufacturing at a commercial scale is an integral part of our development plans for REOLYSIN®," said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics. "We have built a solid relationship with SAFC Pharma through numerous projects ranging from media optimization to scale up efforts, and we are very pleased to be working with an international leader with a proven track record in biologic manufacturing."
"We are very proud to be Oncolytics' chosen partner for cGMP production of REOLYSIN®. Consistent with our previous announcement of a $12 million expansion of capacity, we will be in a position to support commercial production of REOLYSIN®," said Jeffrey L. Strobel, Ph.D., Site Director at SAFC Pharma's Carlsbad operation. The Carlsbad operation of SAFC Pharma supports the viral vector and vaccine community with its process development and analytical laboratory expertise, as well as its cGMP capability (cell and virus banks, bulk virus manufacturing, and formulated, filled, and finished drug).
About SAFC: SAFC® is the custom manufacturing and services group within Sigma-Aldrich that focuses on high-purity inorganics for high technology applications, cell culture products and services for biopharmaceutical manufacturing, biochemical production and the manufacturing of complex, multi-step organic synthesis of APIs and key intermediates. SAFC has manufacturing facilities around the world dedicated to providing manufacturing services for companies requiring a reliable partner to produce their custom manufactured materials. SAFC has four focus areas - SAFC Pharma, SAFC Supply Solutions®, SAFC Biosciences(TM), and SAFC Hitech(TM) - and had annual sales of nearly $600 million in 2007. SAFC is one of the world's 10 largest fine chemical businesses. For more information about SAFC, visit www.safcglobal.com.
About Sigma-Aldrich: Sigma-Aldrich is a leading Life Science and High Technology company. Its biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical and other high technology manufacturing. The Company has customers in life science companies, university and government institutions, hospitals, and in industry. Over one million scientists and technologists use its products. Sigma-Aldrich operates in 36 countries and has 7,900 employees providing excellent service worldwide. Sigma-Aldrich is committed to Accelerating Customer Success through Leadership in Life Science, High Technology and Service. For more information about Sigma-Aldrich, please visit its award-winning Web site at http://www.sigma-aldrich.com.
Yields at the 40-litre scale should provide sufficient doses to support future development plans leading to registration and also anticipated early stage commercial requirements. Development work to support further scale-up to the 100-litre level is currently underway.
"Manufacturing at a commercial scale is an integral part of our development plans for REOLYSIN®," said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics. "We have built a solid relationship with SAFC Pharma through numerous projects ranging from media optimization to scale up efforts, and we are very pleased to be working with an international leader with a proven track record in biologic manufacturing."
"We are very proud to be Oncolytics' chosen partner for cGMP production of REOLYSIN®. Consistent with our previous announcement of a $12 million expansion of capacity, we will be in a position to support commercial production of REOLYSIN®," said Jeffrey L. Strobel, Ph.D., Site Director at SAFC Pharma's Carlsbad operation. The Carlsbad operation of SAFC Pharma supports the viral vector and vaccine community with its process development and analytical laboratory expertise, as well as its cGMP capability (cell and virus banks, bulk virus manufacturing, and formulated, filled, and finished drug).
About SAFC: SAFC® is the custom manufacturing and services group within Sigma-Aldrich that focuses on high-purity inorganics for high technology applications, cell culture products and services for biopharmaceutical manufacturing, biochemical production and the manufacturing of complex, multi-step organic synthesis of APIs and key intermediates. SAFC has manufacturing facilities around the world dedicated to providing manufacturing services for companies requiring a reliable partner to produce their custom manufactured materials. SAFC has four focus areas - SAFC Pharma, SAFC Supply Solutions®, SAFC Biosciences(TM), and SAFC Hitech(TM) - and had annual sales of nearly $600 million in 2007. SAFC is one of the world's 10 largest fine chemical businesses. For more information about SAFC, visit www.safcglobal.com.
About Sigma-Aldrich: Sigma-Aldrich is a leading Life Science and High Technology company. Its biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical and other high technology manufacturing. The Company has customers in life science companies, university and government institutions, hospitals, and in industry. Over one million scientists and technologists use its products. Sigma-Aldrich operates in 36 countries and has 7,900 employees providing excellent service worldwide. Sigma-Aldrich is committed to Accelerating Customer Success through Leadership in Life Science, High Technology and Service. For more information about Sigma-Aldrich, please visit its award-winning Web site at http://www.sigma-aldrich.com.
Tuesday, May 20, 2008
Oncolytics Biotech Inc. Announces Issuance of 27th U.S. Patent
Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) ("Oncolytics") today announced that it has been granted U.S. Patent 7,374,752 entitled "Reovirus for the Treatment of Cellular Proliferative Disorders." The claims cover pharmaceutical compositions which comprise various recombinant reoviruses.
"This patent provides the Company with additional patent protection for reovirus compositions in the United States," said Mary Ann Dillahunty, Vice President of Intellectual Property for Oncolytics.
"This patent provides the Company with additional patent protection for reovirus compositions in the United States," said Mary Ann Dillahunty, Vice President of Intellectual Property for Oncolytics.
Friday, May 16, 2008
Oncolytics Biotech Inc. Collaborators to Present Phase II Sarcoma Trial Results at ASCO Annual Meeting
Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) announced today that an abstract covering interim results of a Phase II study of intravenous REOLYSIN® in patients with sarcomas metastatic to the lung is available on the American Society of Clinical Oncology (ASCO) website at www.asco.org and on the Oncolytics website at www.oncolyticsbiotech.com. The abstract is entitled "A Phase II Study of Intravenous REOLYSIN (Wild-type reovirus) in the Treatment of Patients with Bone and Soft Tissue Sarcomas Metastatic to the Lung." The abstract discusses results of this study up to early January, 2008.
Dr. Monica Mita, Principal Investigator at the Cancer Therapy and Research Center at the University of Texas Health Science Center (CTRC at UTHSC), San Antonio, Texas and her team are scheduled to deliver a poster presentation providing updated information on the trial at the 44th ASCO annual meeting, which runs from May 30 to June 3, 2008 in Chicago, Illinois.
Dr. Monica Mita, Principal Investigator at the Cancer Therapy and Research Center at the University of Texas Health Science Center (CTRC at UTHSC), San Antonio, Texas and her team are scheduled to deliver a poster presentation providing updated information on the trial at the 44th ASCO annual meeting, which runs from May 30 to June 3, 2008 in Chicago, Illinois.
Wednesday, May 14, 2008
Oncolytics Biotech Inc. Announces U.K. Phase II Clinical Trial Investigating REOLYSIN® in Combination with Paclitaxel and Carboplatin
CALGARY, AB, --- May 14, 2008 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that 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 Phase II clinical trial using intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers. The principal investigator is Dr. Kevin Harrington of The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust.
“Interim data recently presented from our U.K. Phase I dose escalation trial of REOLYSIN® in combination with paclitaxel and carboplatin indicated strong and durable responses in patients with advanced head and neck cancers,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We believe it is important to further explore these findings by conducting a Phase II trial in this specific patient population.”
This trial is a 14 patient, single arm, open-label, dose-targeted, non-randomized, multi-centre trial of REOLYSIN® given intravenously in combination with a standard dosage of paclitaxel and carboplatin. Patients with a variety of advanced cancers, including head and neck cancers, will continue to be treated in the ongoing U.K. combination paclitaxel and carboplatin trial.
Eligible patients include those with advanced or metastatic head and neck cancer that are refractory to standard therapy or for which no curative standard therapy exists. The primary objective of the Phase II trial is to measure tumour responses and duration of response, and to describe any evidence of antitumour activity. The secondary objective is to determine the safety and tolerability of REOLYSIN® when administered in combination with paclitaxel and carboplatin to patients with advanced or metastatic head and neck cancer.
“Interim data recently presented from our U.K. Phase I dose escalation trial of REOLYSIN® in combination with paclitaxel and carboplatin indicated strong and durable responses in patients with advanced head and neck cancers,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We believe it is important to further explore these findings by conducting a Phase II trial in this specific patient population.”
This trial is a 14 patient, single arm, open-label, dose-targeted, non-randomized, multi-centre trial of REOLYSIN® given intravenously in combination with a standard dosage of paclitaxel and carboplatin. Patients with a variety of advanced cancers, including head and neck cancers, will continue to be treated in the ongoing U.K. combination paclitaxel and carboplatin trial.
Eligible patients include those with advanced or metastatic head and neck cancer that are refractory to standard therapy or for which no curative standard therapy exists. The primary objective of the Phase II trial is to measure tumour responses and duration of response, and to describe any evidence of antitumour activity. The secondary objective is to determine the safety and tolerability of REOLYSIN® when administered in combination with paclitaxel and carboplatin to patients with advanced or metastatic head and neck cancer.
Friday, May 9, 2008
Oncolytics Biotech Inc. Starts Patient Enrolment in U.K. Combination REOLYSIN(R)/Cyclophosphamide Trial
CALGARY, May 9 - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that it has begun patient enrolment in 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.
"We are hopeful that this trial will provide more information on how we might improve the effectiveness of this promising new approach to treating cancer," said Dr. Spicer.
"In animal models, pretreatment with low-dose immune modulators has been shown to significantly enhance the antitumour activity of REOLYSIN®(ref.)," added Dr. Brad Thompson, President and CEO of Oncolytics. "This study will help confirm if this can also be achieved in humans. If it can, it could lead to exciting opportunities to expand the use of REOLYSIN® for cancer treatment."
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 determining the safety profile of the combination and gathering any evidence of anti-tumour activity.
"We are hopeful that this trial will provide more information on how we might improve the effectiveness of this promising new approach to treating cancer," said Dr. Spicer.
"In animal models, pretreatment with low-dose immune modulators has been shown to significantly enhance the antitumour activity of REOLYSIN®(ref.)," added Dr. Brad Thompson, President and CEO of Oncolytics. "This study will help confirm if this can also be achieved in humans. If it can, it could lead to exciting opportunities to expand the use of REOLYSIN® for cancer treatment."
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 determining the safety profile of the combination and gathering any evidence of anti-tumour activity.
Monday, May 5, 2008
Oncolytics Biotech Inc. Announces Details of 2008 Annual Shareholder Meeting
Oncolytics Biotech Inc. announced today that its 2008 Annual and Special Meeting of the Shareholders will be held on Wednesday, May 7, 2008 at 9:00 a.m. (ET) at the Yale Club of New York City, 50 Vanderbilt Ave, New York.
Following the business portion of the meeting, Dr. Brad Thompson, President and CEO of Oncolytics, will discuss recent progress in developing REOLYSIN® as a potential cancer therapeutic.
A live audio webcast of the presentation will begin at approximately 9:15 a.m. (ET) at:
http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=2266660 or 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.
An audio replay will be accessible following the presentation at www.oncolyticsbiotech.com.
Saturday, May 3, 2008
AGM Webcast
The 2008 Annual and Special Meeting webcast will be held this Wednesday, May 7th at 9:30 am ET. Listen to the webcast here.
Wednesday, April 30, 2008
Oncolytics Biotech Inc. Announces 2008 First Quarter Results
Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) today announced its financial results and highlights for the three month period ended March 31, 2008.
“We are currently enrolling or recruiting patients in a total of nine clinical trials, four exploring the use of REOLYSIN® as a monotherapy, and five exploring the use of REOLYSIN® in combination with a variety of chemotherapies, immune modulation and radiotherapy, ” said Dr. Brad Thompson, President and CEO of Oncolytics. “In 2008, we expect to report interim or final results on a number of our ongoing clinical trials. We are rapidly moving toward the point where we can expect to make pivotal clinical trial decisions about REOLYSIN®. It is an exciting time for Oncolytics and our shareholders.”
First Quarter Highlights
Significant Clinical Advances
“We are currently enrolling or recruiting patients in a total of nine clinical trials, four exploring the use of REOLYSIN® as a monotherapy, and five exploring the use of REOLYSIN® in combination with a variety of chemotherapies, immune modulation and radiotherapy, ” said Dr. Brad Thompson, President and CEO of Oncolytics. “In 2008, we expect to report interim or final results on a number of our ongoing clinical trials. We are rapidly moving toward the point where we can expect to make pivotal clinical trial decisions about REOLYSIN®. It is an exciting time for Oncolytics and our shareholders.”
First Quarter Highlights
Significant Clinical Advances
- Met the criteria to expand to full enrolment of 52 patients in our U.S. Phase II sarcoma trial after the third patient treated in the trial experienced stable disease by RECIST criteria for more than six months.
- In early April, our collaborators presented positive interim results from our U.K. combination REOLYSIN® and paclitaxel/carboplatin trial at the British Society of Gene Therapy conference in Edinburgh. Three head and neck patients evaluated to date have had excellent clinical and radiological responses without appreciable toxicity.
- The U.S. National Cancer Institute filed a protocol with the U.S. FDA to conduct a Phase I/II ovarian, peritoneal and fallopian tube cancer trial. The trial is currently recruiting patients.
- Research characterizing immune system responses to REOLYSIN® in our U.K. Phase I systemic administration trial was published in the March 6 issue of Gene Therapy.
- Two papers were published in Clinical Cancer Research covering preclinical work with reovirus in combination with radiation, and reovirus administration following cyclophosphamide.
- In April, two presentations were made at the American Association for Cancer Research (AACR) covering work using the reovirus in combination with radiation for pediatric sarcomas, and reovirus as a purging agent for autologous stem cell transplants.
- In April, a paper covering preclinical work demonstrating that reovirus can kill melanoma cell lines and freshly resected tumour was published in Gene Therapy.
- Two Canadian patents and one U.S. patent were secured in the quarter.
Wednesday, April 23, 2008
New Article Published in the Journal of Immunology on Reovirus Activation of Dendritic Cells
Oncolytics Biotech announced the publication of the first study that shows that the reovirus directly activates human dendritic cells, and that reovirus-activated dendritic cells stimulate innate killing by natural killer cells and T cells. This suggests a new potential role for T cells in oncolytic virus-induced local tumor cell death.
Read the press release here or below.
Oncolytics Biotech Inc. Announces Journal of Immunology Publication on Reovirus Activation of Dendritic Cells
Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that Prof. Alan Melcher and his research group at St. James’s University Hospital in Leeds, U.K. published the results of their work with reovirus in the May 1, 2008 online issue of The Journal of Immunology. The paper is entitled “Reovirus Activates Human Dendritic Cells to Promote Innate Antitumor Immunity.”
The researchers studied the ability of reovirus to activate human dendritic cells (DC), key regulators of both innate and adaptive immune responses. The data demonstrated that reovirus directly activates human DC, which in turn stimulate innate killing of cancer cells by natural killer (NK) and T cells, suggesting a novel potential role for T cells in oncolytic virus-induced local tumor cell death. Combined with the virus’s ability to directly kill cancer cells, the researchers concluded that reovirus recognition by DC may enhance the efficacy of reovirus as a therapeutic agent.
“This research provides additional insight into how reovirus interacts with the immune system, and expands our understanding of its multiple roles in the killing of cancer cells,” said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics.
To read the journal abstract click here.
Read the press release here or below.
Oncolytics Biotech Inc. Announces Journal of Immunology Publication on Reovirus Activation of Dendritic Cells
Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that Prof. Alan Melcher and his research group at St. James’s University Hospital in Leeds, U.K. published the results of their work with reovirus in the May 1, 2008 online issue of The Journal of Immunology. The paper is entitled “Reovirus Activates Human Dendritic Cells to Promote Innate Antitumor Immunity.”
The researchers studied the ability of reovirus to activate human dendritic cells (DC), key regulators of both innate and adaptive immune responses. The data demonstrated that reovirus directly activates human DC, which in turn stimulate innate killing of cancer cells by natural killer (NK) and T cells, suggesting a novel potential role for T cells in oncolytic virus-induced local tumor cell death. Combined with the virus’s ability to directly kill cancer cells, the researchers concluded that reovirus recognition by DC may enhance the efficacy of reovirus as a therapeutic agent.
“This research provides additional insight into how reovirus interacts with the immune system, and expands our understanding of its multiple roles in the killing of cancer cells,” said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics.
To read the journal abstract click here.
Thursday, April 17, 2008
ClinicalTrials.gov Updated: Now Recruiting Viral Therapy in Treating Patients With Metastatic Melanoma
Viral Therapy in Treating Patients With Metastatic Melanoma
RATIONALE: Viral therapy may be able to kill tumor cells without damaging normal cells.
PURPOSE: This phase II trial is studying the side effects and how well viral therapy works in treating patients with metastatic melanoma.
OBJECTIVES:
Primary
To assess the toxicity profile of Reolysin® in these patients.
RATIONALE: Viral therapy may be able to kill tumor cells without damaging normal cells.
PURPOSE: This phase II trial is studying the side effects and how well viral therapy works in treating patients with metastatic melanoma.
OBJECTIVES:
Primary
To assess the toxicity profile of Reolysin® in these patients.
Secondary
To assess the progression-free survival and overall survival of these patients.
To assess viral replication in metastatic melanoma deposits after intravenous administration of Reolysin®.
To assess the impact of pre-existing anti-reoviral immunity (as represented by p38 expression in pretreatment tumor specimens) on the efficacy and toxicity of Reolysin®.
To measure the effect of Reolysin® on the immune system, in terms of dendritic cell activation, T-cell activation, presence of Treg cells in tumor specimens, and the frequency of T cells, B cells, NK cells, and peptide specific cytotoxic T lymphocytes reactive against melanoma differentiation antigen peptides (gp100, MART-1, and tyrosinase).
To assess the induction of melanoma specific immune response, in terms of the presence of melanoma differentiation antigens (gp100, MART-1, and tyrosinase) in tumor specimens.
OUTLINE:
This is a multicenter study.
Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples are collected at baseline and at 1 week after initiation of treatment for correlative laboratory studies. Tissue samples are analyzed for p38/MAPK activation status by IHC; reoviral replication in metastatic deposits by electron microscopy; and immunologic parameters by IHC. Blood samples are collected at baseline, at 4 weeks after initiation of treatment, and then every 2 months thereafter. Blood samples are analyzed for immunologic parameters by tetramer and ELISPOT technology and for neutralizing antibodies against reovirus.
After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 5 years
Wednesday, April 16, 2008
Article: Cedars-Sinai Medical Center opens patient trial of virus that attacks brain cancer cells
LOS ANGELES (April 15, 2008) – A common, naturally occurring virus that attacks cancer cells but appears to be harmless to normal cells is being studied as a possible treatment for malignant, highly aggressive and deadly brain tumors called gliomas. Researchers at Cedars-Sinai Medical Center are among a few in the United States evaluating this experimental therapy.
Read more here.
For more information on the glioma study, which is offered through the Johnnie L. Cochran, Jr. Brain Tumor Center, patients may contact Cedars-Sinai Medical Center at 1-800-CEDARS-1 or at www.csmc.edu under “Clinical Trials.”
Oncolytics Biotech Inc. Announces Gene Therapy Publication on Reovirus Treatment for Melanoma
Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that Prof. Alan Melcher and his research group at St. James's University Hospital in Leeds, U.K. published the results of their work in the April 10 online issue of Gene Therapy. The paper is entitled "Inflammatory Tumour Cell Killing by Oncolytic Reovirus for the Treatment of Melanoma."
The investigators showed that reovirus effectively kills and replicates in both human melanoma cell lines and freshly resected tumour. They demonstrated that reovirus melanoma killing is more potent than, and distinct from, chemotherapy or radiotherapy-induced cell death. They concluded that reovirus is suitable for clinical testing in melanoma.
"Our ongoing preclinical work indicates that reovirus has a number of mechanisms by which it kills melanoma cell lines and tumours," said Dr. Brad Thompson, President and CEO of Oncolytics. "This most recent work provides additional support to our upcoming Phase II melanoma clinical trial with the U.S. National Cancer Institute."
The investigators showed that reovirus effectively kills and replicates in both human melanoma cell lines and freshly resected tumour. They demonstrated that reovirus melanoma killing is more potent than, and distinct from, chemotherapy or radiotherapy-induced cell death. They concluded that reovirus is suitable for clinical testing in melanoma.
"Our ongoing preclinical work indicates that reovirus has a number of mechanisms by which it kills melanoma cell lines and tumours," said Dr. Brad Thompson, President and CEO of Oncolytics. "This most recent work provides additional support to our upcoming Phase II melanoma clinical trial with the U.S. National Cancer Institute."
Tuesday, April 15, 2008
Oncolytics Biotech Inc. Collaborators Present Reovirus Research for Multiple Myeloma at AACR Annual Meeting
Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) announced that an oral presentation by Dr. Chandini Thirukkumaran of the Tom Baker Cancer Centre, Calgary, entitled "Targeting Multiple Myeloma with Oncolytic Viral Therapy" was presented today at the American Association for Cancer Research (AACR) Annual Meeting. The meeting is being held in San Diego, California from April 12-16, 2008.
The presentation covered preclinical work using reovirus as a purging agent during autologous (harvested from the patient themselves) hematopoietic stem cell transplants for multiple myeloma. The results demonstrated that up to 70% of multiple myeloma cell lines tested showed reovirus sensitivity and reovirus induced cell death mediated through apoptosis.
The investigators concluded that this preclinical data supports initiating a Phase I purging trial using reovirus against multiple myeloma.
Oncolytics Biotech Inc. Collaborators Present Reovirus Research for Pediatric Sarcomas at AACR Annual Meeting
Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) announced that a poster presentation by Dr. Anders Kolb of the Nemours Center for Childhood Cancer Research entitled “Radiation in Combination with Reolysin for Pediatric Sarcomas” was presented today at the American Association for Cancer Research (AACR) Annual Meeting. The meeting is being held in San Diego, California from April 12-16, 2008.
“The combination of REOLYSIN® with radiation is certainly favourable,” said Dr. Kolb. “Statistically significant improvements in event-free survival are seen in mice treated with the combination when compared to either therapy alone.”
The poster covers preclinical work using reovirus in combination with radiation in mice implanted with pediatric rhabdomyosarcoma and Ewing’s sarcoma tumours. The results demonstrated that the combination of reovirus and radiation significantly enhanced efficacy compared to either treatment alone in terms of tumour regression and event-free survival.
“We are very pleased to be working with investigators such as Dr. Kolb,” said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics. “The work completed by Dr. Kolb and his team supports our ongoing efforts in our human trials with REOLYSIN®.”
The poster will be available on the Oncolytics website today at www.oncolyticsbiotech.com
Click here to go to the poster.
“The combination of REOLYSIN® with radiation is certainly favourable,” said Dr. Kolb. “Statistically significant improvements in event-free survival are seen in mice treated with the combination when compared to either therapy alone.”
The poster covers preclinical work using reovirus in combination with radiation in mice implanted with pediatric rhabdomyosarcoma and Ewing’s sarcoma tumours. The results demonstrated that the combination of reovirus and radiation significantly enhanced efficacy compared to either treatment alone in terms of tumour regression and event-free survival.
“We are very pleased to be working with investigators such as Dr. Kolb,” said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics. “The work completed by Dr. Kolb and his team supports our ongoing efforts in our human trials with REOLYSIN®.”
The poster will be available on the Oncolytics website today at www.oncolyticsbiotech.com
Click here to go to the poster.
Monday, April 14, 2008
Oncolytics Biotech Inc. Completes Dose Escalation in Combination Reolysin/Paclitaxel and Carboplatin Trial
Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) has completed patient enrolment in the dose escalation portion of its U.K. clinical trial to evaluate the anti-tumour effects of systemic administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with advanced cancers including head and neck, melanoma, lung and ovarian.
"The preliminary results from this combination trial are very encouraging," said Dr. Brad Thompson, President and CEO of Oncolytics. "This study was the first to begin examining the use of REOLYSIN® with drug combinations that are used in first or second line therapy.
The principal investigators are Dr. Kevin Harrington of The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, and Dr. Geoff Hall of St. James's Hospital in Leeds, U.K.
The trial (REO 011) has two components. The first is an open-label, dose-escalating, non-randomized study of REOLYSIN® given intravenously with paclitaxel and carboplatin every three weeks. Standard dosages of paclitaxel and carboplatin were delivered to patients with escalating dosages of REOLYSIN® intravenously. The second component of the trial includes the enrolment of a further 12 patients at the maximum dosage of REOLYSIN® in combination with a standard dosage of paclitaxel and carboplatin.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours such as head and neck, melanoma, lung and ovarian cancers that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists. The primary objective of the trial is to determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), recommended dose and dosing schedule and safety profile of REOLYSIN® when administered in combination with paclitaxel and carboplatin. 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.
In the U.K. and the U.S., approximately 350,000 people are diagnosed annually with head & neck, melanoma, lung and ovarian cancers.
Friday, April 11, 2008
Viral Therapy in Treating Patients With Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Did Not Respond
This study is currently recruiting participants.
RATIONALE: Viral therapy may be able to kill tumor cells without damaging normal cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of viral therapy in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that did not respond to platinum chemotherapy.
OBJECTIVES:
Primary
- To determine the safety and tolerability of intravenous (IV) and intraperitoneal (IP) administration of wild-type reovirus (REOLYSIN®). (Phase I)
- To determine the maximum tolerated dose of IP REOLYSIN® when used with a fixed dose of IV REOLYSIN®. (Phase I)
- To determine the objective response rate (complete response and partial response per RECIST criteria) of treatment with IV and IP REOLYSIN® in patients with recurrent, platinum-refractory ovarian epithelial, peritoneal, or fallopian tube carcinoma. (Phase II)
Secondary
- To identify viral replication in tumor following IV reovirus.
- To identify anti-reovirus antibodies in patients being treated with IV and IP REOLYSIN® therapy.
- To identify viral replication in the abdominal washings of patients undergoing IV and IP REOLYSIN® therapy.
- To correlate response to therapy with Ras oncogene status.
- To evaluate double-stranded RNA-activated protein kinase activity in tumors.
- To correlate molecular predictors of response to REOLYSIN® therapy.
OUTLINE: This is a phase I, dose-escalation study of intraperitoneal (IP) wild-type reovirus when administered with fixed dose IV wild-type reovirus followed by a phase II study.
Phase I: Patients receive wild-type reovirus IV over 60 minutes on days 1-5 in course 1, followed by insertion of an IP access port. Beginning in course 2, patients receive wild-type reovirus IV over 60 minutes on days 1-5 and wild-type reovirus IP over 10 minutes on days 1 and 2*. Treatment with IV and IP wild-type reovirus repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Phase II: Patients undergo IP access port insertion before beginning treatment. Patients receive wild-type reovirus IV over 60 minutes on days 1-5 and IP (at the maximum tolerated dose determined in phase I) over 10 minutes on days 1 and 2*. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients receive IP wild-type reovirus on days 2 and 3 in course 3.
Prior to each IP wild-type reovirus administration, normal saline is administered through the IP catheter and withdrawn for correlative studies in courses 2 and 3 (phase I) or courses 1 and 2 (phase II). Patients also undergo a CT-guided percutaneous tumor biopsy on day 2 of course 3 (phase I or II). Samples are analyzed by immunohistochemistry, RT-PCR, and electron microscopy for the relevant molecular effects of wild-type reovirus on tumor and normal tissue.
After completion of study treatment, patients are followed for up to 12 weeks.
PROJECTED ACCRUAL: A total of 70 patients (up to 30 for phase I and 40 for phase II) will be accrued for this study.
For more information go here.
Wednesday, April 9, 2008
Oncolytics Biotech Inc. Reports Positive Interim Results of U.K. Combination REOLYSIN® and Carboplatin/Paclitaxel Trial
CALGARY, AB, --- April 9, 2008 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) today announced positive interim results from its U.K. combination REOLYSIN® and carboplatin/paclitaxel trial. Dr. Kevin Harrington of The Institute of Cancer Research, London, and the principal investigator for the trial, presented the results today at The 5th Annual Conference of the British Society for Gene Therapy (BSGT) in Edinburgh, Scotland.
Four of the first eight patients treated in the study to date have a diagnosis of carcinoma of the head and neck. All three head and neck patients evaluated to date have had excellent clinical and radiological responses without appreciable toxicity. Preliminary assessment after recruitment of the first two cohorts has suggested that patients with head and neck carcinomas may represent a group of patients in whom the combination of carboplatin/paclitaxel and REOLYSIN® is active.
“These early results in head and neck patients are remarkable, considering the prognosis for refractory patients is generally poor,” said Dr. Karl Mettinger, Chief Medical Officer for Oncolytics.
In the first cohort, the patient with head and neck cancer received 8 cycles of treatment (the maximum allowed) and achieved a clinical complete response. In the second cohort, the two patients with head and neck cancers with widespread disseminated disease have each received six cycles of treatment to date and both have achieved significant partial responses. Two of the three patients, including the patient with the clinical complete response, had previously received cisplatin/5-FU treatment and all three had previously received radiotherapy.
More information about this clinical trial, including CT scans from selected patients enrolled on the trial, can be found on the Oncolytics website at www.oncolyticsbiotech.com.
The primary objective of the trial is to determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), recommended dose and dosing schedule and safety profile of REOLYSIN® when administered in combination with paclitaxel and carboplatin. 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.
The principal investigators are Dr. Kevin Harrington of The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, and Dr. Geoff Hall of St. James’s Hospital in Leeds, U.K.
Four of the first eight patients treated in the study to date have a diagnosis of carcinoma of the head and neck. All three head and neck patients evaluated to date have had excellent clinical and radiological responses without appreciable toxicity. Preliminary assessment after recruitment of the first two cohorts has suggested that patients with head and neck carcinomas may represent a group of patients in whom the combination of carboplatin/paclitaxel and REOLYSIN® is active.
“These early results in head and neck patients are remarkable, considering the prognosis for refractory patients is generally poor,” said Dr. Karl Mettinger, Chief Medical Officer for Oncolytics.
In the first cohort, the patient with head and neck cancer received 8 cycles of treatment (the maximum allowed) and achieved a clinical complete response. In the second cohort, the two patients with head and neck cancers with widespread disseminated disease have each received six cycles of treatment to date and both have achieved significant partial responses. Two of the three patients, including the patient with the clinical complete response, had previously received cisplatin/5-FU treatment and all three had previously received radiotherapy.
More information about this clinical trial, including CT scans from selected patients enrolled on the trial, can be found on the Oncolytics website at www.oncolyticsbiotech.com.
The primary objective of the trial is to determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), recommended dose and dosing schedule and safety profile of REOLYSIN® when administered in combination with paclitaxel and carboplatin. 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.
The principal investigators are Dr. Kevin Harrington of The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, and Dr. Geoff Hall of St. James’s Hospital in Leeds, U.K.
Wednesday, March 26, 2008
2008 AACR Annual Meeting Presentation Information
Some of you may have already seen this, but here is the schedule for the Oncolytics Biotech related presentations with excerpts from the abstracts.
Abstract Number: 906
Session Title: Therapeutic Implications of Oncogenic Pathways 1
Presentation Title: Replication of mutant strains of oncolytic reovirus in different cell lines
Presentation Start/End Time: Sunday, Apr 13, 2008, 1:00 PM - 5:00 PM
Location: Exhibit Hall B-F, San Diego Convention Center
Poster Section: 5
Poster Board Number: 17
Author Block: Guy Lemay. Universite de Montreal, Montreal, QC, Canada
Murine NIH-3T3 cells are poorly infected by mammalian reovirus but support productive infection upon cell transformation by H-Ras(G12V), leading to the idea that reovirus could be used as an “oncolytic” virus.
Altogether, our data thus support the idea that cellular factors affecting reovirus replication are complex and linked to pathways leading to cellular transformation. We further suggest that viral strains should be chosen or manipulated to optimize their oncolytic potential. The σ3 protein appears as the most likely viral factor to be involved in modulating the virus’ ability to replicate in different normal or transformed cell types.
See the original page here.
Abstract Number: 3751
Session Title: Pediatric Cancer 3
Presentation Title: Radiation in combination with Reolysin for pediatric sarcomas
Presentation Start/End Time: Tuesday, Apr 15, 2008, 8:00 AM -12:00 PM
Location: Exhibit Hall B-F, San Diego Convention Center
Poster Section: 15
Poster Board Number: 12
Author Block: Pooja Gidwani, Wendong Zhang, Laibin Liu, Chandan Guha, E Anders Kolb. Albert Einstein College of Medicine, Bronx, NY, A I duPont Children's Hospital, Wilmington, DE
With advances in the scientific knowledge of molecular mechanisms of cancer and viral replication, oncolytic viruses have emerged as an interesting potential therapeutic strategy for several human cancers.
Conclusions: Our data suggests that the combination of reovirus and radiation therapy has enhanced efficacy than either of the individual treatments alone in pediatric sarcomas. This is especially interesting since reovirus was administered systemically instead of intratumorally suggesting the potential use of this treatment modality even in metastatic and hard to reach tumors. Our data warrants further testing of this combination in clinical trials.
See the original page here.
Abstract Number: 4971
Session Title: Novel Genomic Approaches, Drugs, Targets, and Strategies
Presentation Title: Targeting multiple myeloma with oncolytic viral therapy
Presentation Start/End Time: Tuesday, Apr 15, 2008, 4:40 PM - 4:55 PM
Location: Room 30A-C, San Diego Convention Center
Author Block: Chandini M. Thirukkumaran, Zhong-Qiao Shi, Jason Spurell, Douglas Stewart, Joanne Luider, Don Morris. Tom Baker Cancer Centre, Calgary, AB, Canada, Calgary Laboratory Services, Calgary, AB, Canada
In the present study we investigate 1) The oncolytic ability of reovirus against a larger number of MM cell lines and ex vivo patient specimens in order to assess MM sensitivity to reovirus in a community population, 2) Reovirus purging efficacy in a murine model of transplantation.
Conclusions: The sensitivity of reovirus towards MM and its lack of effect human stem cells highlight the potential of reovirus as a purging agent during autologous hematopoietic stem cell transplants for MM. The SCID/NOD model system used in the present study appears suitable for evaluating reovirus purging efficacy in vivo. Currently, we are in the process of studying reovirus purging efficacy in vivo and its purging capacity of ex vivo MM patient tumor in order to generate data for a future phase I clinical trial.
See the original page here.
Abstract Number: 906
Session Title: Therapeutic Implications of Oncogenic Pathways 1
Presentation Title: Replication of mutant strains of oncolytic reovirus in different cell lines
Presentation Start/End Time: Sunday, Apr 13, 2008, 1:00 PM - 5:00 PM
Location: Exhibit Hall B-F, San Diego Convention Center
Poster Section: 5
Poster Board Number: 17
Author Block: Guy Lemay. Universite de Montreal, Montreal, QC, Canada
Murine NIH-3T3 cells are poorly infected by mammalian reovirus but support productive infection upon cell transformation by H-Ras(G12V), leading to the idea that reovirus could be used as an “oncolytic” virus.
Altogether, our data thus support the idea that cellular factors affecting reovirus replication are complex and linked to pathways leading to cellular transformation. We further suggest that viral strains should be chosen or manipulated to optimize their oncolytic potential. The σ3 protein appears as the most likely viral factor to be involved in modulating the virus’ ability to replicate in different normal or transformed cell types.
See the original page here.
Abstract Number: 3751
Session Title: Pediatric Cancer 3
Presentation Title: Radiation in combination with Reolysin for pediatric sarcomas
Presentation Start/End Time: Tuesday, Apr 15, 2008, 8:00 AM -12:00 PM
Location: Exhibit Hall B-F, San Diego Convention Center
Poster Section: 15
Poster Board Number: 12
Author Block: Pooja Gidwani, Wendong Zhang, Laibin Liu, Chandan Guha, E Anders Kolb. Albert Einstein College of Medicine, Bronx, NY, A I duPont Children's Hospital, Wilmington, DE
With advances in the scientific knowledge of molecular mechanisms of cancer and viral replication, oncolytic viruses have emerged as an interesting potential therapeutic strategy for several human cancers.
Conclusions: Our data suggests that the combination of reovirus and radiation therapy has enhanced efficacy than either of the individual treatments alone in pediatric sarcomas. This is especially interesting since reovirus was administered systemically instead of intratumorally suggesting the potential use of this treatment modality even in metastatic and hard to reach tumors. Our data warrants further testing of this combination in clinical trials.
See the original page here.
Abstract Number: 4971
Session Title: Novel Genomic Approaches, Drugs, Targets, and Strategies
Presentation Title: Targeting multiple myeloma with oncolytic viral therapy
Presentation Start/End Time: Tuesday, Apr 15, 2008, 4:40 PM - 4:55 PM
Location: Room 30A-C, San Diego Convention Center
Author Block: Chandini M. Thirukkumaran, Zhong-Qiao Shi, Jason Spurell, Douglas Stewart, Joanne Luider, Don Morris. Tom Baker Cancer Centre, Calgary, AB, Canada, Calgary Laboratory Services, Calgary, AB, Canada
In the present study we investigate 1) The oncolytic ability of reovirus against a larger number of MM cell lines and ex vivo patient specimens in order to assess MM sensitivity to reovirus in a community population, 2) Reovirus purging efficacy in a murine model of transplantation.
Conclusions: The sensitivity of reovirus towards MM and its lack of effect human stem cells highlight the potential of reovirus as a purging agent during autologous hematopoietic stem cell transplants for MM. The SCID/NOD model system used in the present study appears suitable for evaluating reovirus purging efficacy in vivo. Currently, we are in the process of studying reovirus purging efficacy in vivo and its purging capacity of ex vivo MM patient tumor in order to generate data for a future phase I clinical trial.
See the original page here.
Wednesday, March 19, 2008
Dr. Francis J. Giles receives Irish Medical Science Award
Article from the UT Health Science Center website detailing the honor awarded Dr. Giles which was mentioned in my previous post.
SAN ANTONIO — The Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center at San Antonio announced today that Francis J. Giles, M.D., M.B., F.R.C.P.I., F.R.C.Path, received the Medtronic Award at the National University of Ireland Galway Alumni Awards Gala. The Medtronic Award for Healthcare and Medical Science acknowledges Dr. Giles’ contributions to the field of health care and medical science.
Dr. Giles is the deputy director of the CTRC and director of The Institute for Drug Development, CTRC’s internationally acclaimed oncology drug development program. He also serves concurrently as the chief of the Division of Hematology and Medical Oncology at the Health Science Center. Dr. Giles, who received his medical training at the National University of Ireland Galway, has focused his clinical and research efforts on providing therapy for patients suffering from treatment-resistant or refractory cancer. His interests include lymphomas, multiple myeloma, developmental therapeutics, stem cell transplantation and leukemias. He has pioneered the use of many agents that are now in regular use as targeted therapies for patients with cancer.
“I am delighted and honored to be a recipient of this award,” Dr. Giles said. “I am grateful to accept this award on behalf of the enormous number of people in a wide variety of preclinical and clinical disciplines who are working so hard around the world to eliminate cancer.”The N.U.I. Galway’s ninth annual gala banquet took place at the Radisson SAS Hotel in Galway, Ireland, on Saturday, March 1, 2008.
The Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio, located in San Antonio, Texas, is one of the nation’s leading academic research and treatment centers, serving more than 4.4 million people in the high-growth corridor of Central and South Texas including Austin, San Antonio, Laredo and the Rio Grande Valley. CTRC is one of a few elite cancer centers in the country to be named a National Cancer Institute-Designated Cancer Center and is one of only three in Texas. CTRC handles more than 120,000 patient visits each year and is a world leader in developing new drugs to treat cancer. The CTRC Institute for Drug Development is internationally recognized for conducting the largest oncology Phase I clinical drug trials program in the world, and participated in the clinical and/or preclinical development of many of the cancer drugs approved by the U.S. Food & Drug Administration. For more information, visit www.ctrc.uthscsa.edu.
To see the original article go here.
SAN ANTONIO — The Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center at San Antonio announced today that Francis J. Giles, M.D., M.B., F.R.C.P.I., F.R.C.Path, received the Medtronic Award at the National University of Ireland Galway Alumni Awards Gala. The Medtronic Award for Healthcare and Medical Science acknowledges Dr. Giles’ contributions to the field of health care and medical science.
Dr. Giles is the deputy director of the CTRC and director of The Institute for Drug Development, CTRC’s internationally acclaimed oncology drug development program. He also serves concurrently as the chief of the Division of Hematology and Medical Oncology at the Health Science Center. Dr. Giles, who received his medical training at the National University of Ireland Galway, has focused his clinical and research efforts on providing therapy for patients suffering from treatment-resistant or refractory cancer. His interests include lymphomas, multiple myeloma, developmental therapeutics, stem cell transplantation and leukemias. He has pioneered the use of many agents that are now in regular use as targeted therapies for patients with cancer.
“I am delighted and honored to be a recipient of this award,” Dr. Giles said. “I am grateful to accept this award on behalf of the enormous number of people in a wide variety of preclinical and clinical disciplines who are working so hard around the world to eliminate cancer.”The N.U.I. Galway’s ninth annual gala banquet took place at the Radisson SAS Hotel in Galway, Ireland, on Saturday, March 1, 2008.
The Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio, located in San Antonio, Texas, is one of the nation’s leading academic research and treatment centers, serving more than 4.4 million people in the high-growth corridor of Central and South Texas including Austin, San Antonio, Laredo and the Rio Grande Valley. CTRC is one of a few elite cancer centers in the country to be named a National Cancer Institute-Designated Cancer Center and is one of only three in Texas. CTRC handles more than 120,000 patient visits each year and is a world leader in developing new drugs to treat cancer. The CTRC Institute for Drug Development is internationally recognized for conducting the largest oncology Phase I clinical drug trials program in the world, and participated in the clinical and/or preclinical development of many of the cancer drugs approved by the U.S. Food & Drug Administration. For more information, visit www.ctrc.uthscsa.edu.
To see the original article go here.
Article: Viruses set to 'kill' cancer
Interview with Doctor Frank Giles
From the Irish Medical Times
http://www.imt.ie/news/2008/03/viruses_set_to_kill_cancer.html
by Gary Culliton
Galway-born Dr Frank Giles is responsible for cancer care in a much larger population than the entire island of Ireland. He heads up functional clinical cancer services for many millions of people in Texas as Chief of the Division of Haematology and Medical Oncology at the San Antonio Cancer Institute. These include radiation oncology and surgical oncology.
“To me, the concept of Ireland as discrete units, rather than one functioning medical complex, doesn’t bear any approximation of the reality of the world now,” he told Irish Medical Times before receiving the Medtronic Award for Healthcare & Medical Science from NUI Galway recently.
Viruses are hard to kill and for this reason, Dr Giles’ team is working towards targeting them at cancer. Part of the reason a virus attacks in particular places in our body at certain times, depends on the metabolic state of the cells.
“If a virus likes to infect cells that have a specific kinase pattern, maybe we can find cancers that preferentially have that profile. We now have administered a virus to humans as an anti-cancer agent,” Dr Giles said. “There have been sufficient responses in the first cohort of 12 people to expand the study.” Dr Giles is working on three anti-cancer viruses: GT-111, Reolysin and SVV-001.
Kinase activation
Dr Giles’ team will be publishing a paper on the subject shortly. The fairly benign virus reolysin likes to infect and kill the cells of one difficult-to-treat sarcoma – a nasty solid tumour with a particular kinase activation. Dr Giles’ team in San Antonio has treated an initial 12 people with this virus.
“At least one is responding and some others have stable disease, so we’re expanding the study. It’s very early, we don’t even know how much is a good dose of the virus to administer. But it’s a whole new world. In this new century, we may be able to turn these traditional enemies of ours to our advantage,” he said. Another virus is designed to switch off or kill the new blood supply which metastatic tumours subtend to themselves.
Dr Giles is also the Director of the Experimental Therapeutics Program at the San Antonio Cancer Institute. He has pioneered the use of many agents that are now in regular use as targeted therapies for patients with cancer. He has focused his clinical and research efforts on providing therapy for patients suffering from treatment-resistant or refractory cancer. His interests include lymphomas, multiple myeloma, developmental therapeutics, stem cell transplantation and leukaemias.
Cell population needed
Even in tumours where there is very high percentage cell ‘kill’ following therapy, that does not equate to cure. “We know that there is a very small percentage of cancer cells that are capable of propagating and keeping the tumour alive,” Dr Giles said. “That is the cell population which you need to eliminate. Quite often, they have subtle but important differences from their progeny.”
In the next ten years, it is thought that we will see cancer treatment move away from long-term remission to targeted cures. Hard-to-access cancer stem cells are the final barrier to a very significant increase in the cure rate. These cells are the last grouping which needs to be understood, in order to cure a lot more people. The impact of Dr Giles’ work in this area will be felt in general clinics within five years.
Following his work in the areas of leukaemia, lymphoma and myeloma, Dr Giles is now focused more on the solid tumours like sarcoma and ovarian cancer. “As the therapy changes, the old divides between histology – what a solid lump of tumour looks like versus a leukaemia – are becoming much less important than what actually drives the cancer,” Dr Giles said.
Chronic myeloid leukaemia and a gastro-intestinal solid tumour (GIST) look as different as night and day. However, both are driven by molecular abnormalities that are sensitive to the same drug Gleevec (imatinib) that Dr Giles was involved in developing. Pathology is as important as ever, but disorders which may not be remotely alike may be susceptible to a common mode of attack. Agents can target kinase cell-proliferating enzymes. These are modulated in normal tissue. Genetically, these are driven hyper-active in a tumour.
Dr Giles left Galway, where he had worked, almost 20 years ago. He went to St James’s Hospital in Dublin, then to London, to Chapel Hill in North Carolina and then to UCLA in California. He has been in Texas for 11 years.
“We can do much of the feasibility work in getting a drug to switch off a receptor before the drug is even found. In my days in Galway, I would not have imagined that in a medical career, I would regularly be in contact with crystalographers. Somebody has to design a target and ask if it is drugable, if we can get a drug in there. The more sophisticated the drugs become, the less experimental we are. There is much more targeting,” Dr Giles said.
Returning to Ireland
“Returning to Ireland and contributing to Irish medicine at this level is something that is very important to me,” said Dr Giles, who is likely in the future to take up a university position based between Dublin and Galway. “In the process of doing these things, we do generate a lot of intellectual property (IP) patents. It is time for Ireland to advance to the more revenue-rich environment of generating the IP and developing the compounds themselves,” he added.
From the Irish Medical Times
http://www.imt.ie/news/2008/03/viruses_set_to_kill_cancer.html
by Gary Culliton
Galway-born Dr Frank Giles is responsible for cancer care in a much larger population than the entire island of Ireland. He heads up functional clinical cancer services for many millions of people in Texas as Chief of the Division of Haematology and Medical Oncology at the San Antonio Cancer Institute. These include radiation oncology and surgical oncology.
“To me, the concept of Ireland as discrete units, rather than one functioning medical complex, doesn’t bear any approximation of the reality of the world now,” he told Irish Medical Times before receiving the Medtronic Award for Healthcare & Medical Science from NUI Galway recently.
Viruses are hard to kill and for this reason, Dr Giles’ team is working towards targeting them at cancer. Part of the reason a virus attacks in particular places in our body at certain times, depends on the metabolic state of the cells.
“If a virus likes to infect cells that have a specific kinase pattern, maybe we can find cancers that preferentially have that profile. We now have administered a virus to humans as an anti-cancer agent,” Dr Giles said. “There have been sufficient responses in the first cohort of 12 people to expand the study.” Dr Giles is working on three anti-cancer viruses: GT-111, Reolysin and SVV-001.
Kinase activation
Dr Giles’ team will be publishing a paper on the subject shortly. The fairly benign virus reolysin likes to infect and kill the cells of one difficult-to-treat sarcoma – a nasty solid tumour with a particular kinase activation. Dr Giles’ team in San Antonio has treated an initial 12 people with this virus.
“At least one is responding and some others have stable disease, so we’re expanding the study. It’s very early, we don’t even know how much is a good dose of the virus to administer. But it’s a whole new world. In this new century, we may be able to turn these traditional enemies of ours to our advantage,” he said. Another virus is designed to switch off or kill the new blood supply which metastatic tumours subtend to themselves.
Dr Giles is also the Director of the Experimental Therapeutics Program at the San Antonio Cancer Institute. He has pioneered the use of many agents that are now in regular use as targeted therapies for patients with cancer. He has focused his clinical and research efforts on providing therapy for patients suffering from treatment-resistant or refractory cancer. His interests include lymphomas, multiple myeloma, developmental therapeutics, stem cell transplantation and leukaemias.
Cell population needed
Even in tumours where there is very high percentage cell ‘kill’ following therapy, that does not equate to cure. “We know that there is a very small percentage of cancer cells that are capable of propagating and keeping the tumour alive,” Dr Giles said. “That is the cell population which you need to eliminate. Quite often, they have subtle but important differences from their progeny.”
In the next ten years, it is thought that we will see cancer treatment move away from long-term remission to targeted cures. Hard-to-access cancer stem cells are the final barrier to a very significant increase in the cure rate. These cells are the last grouping which needs to be understood, in order to cure a lot more people. The impact of Dr Giles’ work in this area will be felt in general clinics within five years.
Following his work in the areas of leukaemia, lymphoma and myeloma, Dr Giles is now focused more on the solid tumours like sarcoma and ovarian cancer. “As the therapy changes, the old divides between histology – what a solid lump of tumour looks like versus a leukaemia – are becoming much less important than what actually drives the cancer,” Dr Giles said.
Chronic myeloid leukaemia and a gastro-intestinal solid tumour (GIST) look as different as night and day. However, both are driven by molecular abnormalities that are sensitive to the same drug Gleevec (imatinib) that Dr Giles was involved in developing. Pathology is as important as ever, but disorders which may not be remotely alike may be susceptible to a common mode of attack. Agents can target kinase cell-proliferating enzymes. These are modulated in normal tissue. Genetically, these are driven hyper-active in a tumour.
Dr Giles left Galway, where he had worked, almost 20 years ago. He went to St James’s Hospital in Dublin, then to London, to Chapel Hill in North Carolina and then to UCLA in California. He has been in Texas for 11 years.
“We can do much of the feasibility work in getting a drug to switch off a receptor before the drug is even found. In my days in Galway, I would not have imagined that in a medical career, I would regularly be in contact with crystalographers. Somebody has to design a target and ask if it is drugable, if we can get a drug in there. The more sophisticated the drugs become, the less experimental we are. There is much more targeting,” Dr Giles said.
Returning to Ireland
“Returning to Ireland and contributing to Irish medicine at this level is something that is very important to me,” said Dr Giles, who is likely in the future to take up a university position based between Dublin and Galway. “In the process of doing these things, we do generate a lot of intellectual property (IP) patents. It is time for Ireland to advance to the more revenue-rich environment of generating the IP and developing the compounds themselves,” he added.
Tuesday, March 18, 2008
Oncolytics Biotech Inc. Announces Issuance of 26th U.S. Patent
CALGARY, March 18 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) ("Oncolytics") today announced that it has been granted U.S. Patent 7,344,711 entitled "Use of Adenoviruses Mutated in the VA Genes for Cancer Treatment." The claims describe methods of treating cancer using adenoviruses that are modified to selectively replicate in cancer cells that have an activated Ras pathway.
"This patent expands our adenovirus portfolio both geographically and with respect to which adenovirus variants can be used," said Mary Ann Dillahunty, Vice President of Intellectual Property for Oncolytics.
Monday, March 17, 2008
Oncolytics Biotech Inc. Announces Publication of Research on Immune Response to REOLYSIN(R) during a Phase I Clinical Trial
CALGARY, March 17 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) ('Oncolytics') reported today that Dr. Kevin Harrington and his research group at The Institute of Cancer Research, London, U.K. published the results of their work characterizing immune system responses to administration of intravenous REOLYSIN® in a Phase I clinical trial. The paper, entitled "Characterization of the Adaptive and Innate Immune Response to Intravenous Oncolytic Reovirus (Dearing Type 3) during a Phase I Clinical Trial" appears online in the March 6, 2008 issue of Gene Therapy.
"This important work further defines the relationship between viral therapy and human immune response, and supports the development of our ongoing Phase II clinical trial program," said Dr. Brad Thompson, President and CEO of Oncolytics.
The investigators conducted a detailed analysis of the immune effects of intravenous viral therapy by collecting and analyzing immune response to the presence of the virus. The results suggest that reovirus may stimulate the immune system to mount a dynamic immune response to the presence of virus, increasing the potential to significantly enhance the efficacy of oncolytic virotherapy. About a third of those patients also showed increases in NK (natural killer) cells following therapy. The data support the development of interventions aimed at blunting the patient's immune response, although preclinical data also suggest that maintaining a baseline level is necessary to restrict systemic spread/toxicity of the virus.
Read the abstract here.
"This important work further defines the relationship between viral therapy and human immune response, and supports the development of our ongoing Phase II clinical trial program," said Dr. Brad Thompson, President and CEO of Oncolytics.
The investigators conducted a detailed analysis of the immune effects of intravenous viral therapy by collecting and analyzing immune response to the presence of the virus. The results suggest that reovirus may stimulate the immune system to mount a dynamic immune response to the presence of virus, increasing the potential to significantly enhance the efficacy of oncolytic virotherapy. About a third of those patients also showed increases in NK (natural killer) cells following therapy. The data support the development of interventions aimed at blunting the patient's immune response, although preclinical data also suggest that maintaining a baseline level is necessary to restrict systemic spread/toxicity of the virus.
Read the abstract here.
Thursday, March 13, 2008
Oncolytics Biotech Inc. Collaborators to Present Reovirus Research at AACR Annual Meeting
CALGARY, AB, --- March 13, 2008 -Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) announced that two abstracts covering preclinical work with reovirus are available today on the American Association for Cancer Research (AACR) website at www.aacr.org, and on the Oncolytics website at www.oncolyticsbiotech.com. Both presentations are scheduled to be delivered at the AACR Annual Meeting in San Diego, California April 12-16, 2008.
The first abstract, entitled "Targeting Multiple Myeloma with Oncolytic Viral Therapy" covers preclinical work using reovirus as a purging agent during autologous (harvested from the patient themselves) hematopoietic stem cell transplants for multiple myeloma. The results demonstrated that up to 70% of multiple myeloma cell lines tested showed reovirus sensitivity and reovirus induced cell death mediated through apoptosis. An oral presentation is scheduled to be delivered by Dr. Chandini Thirukkumaran of the Tom Baker Cancer Centre, Calgary, AB on Tuesday, April 15, 2008.
The second abstract, entitled "Radiation in Combination with Reolysin for Pediatric Sarcomas" covers preclinical work using reovirus in combination with radiation in mice implanted with pediatric rhabdomyosarcoma and Ewing's sarcoma tumours. The results demonstrated that the combination of reovirus and radiation significantly enhanced efficacy compared to either treatment alone in terms of tumour regression and event free survival. A poster presentation is scheduled to be delivered by Dr. Pooja Gidwani of the Albert Einstein College of Medicine, Bronx, New York on Tuesday, April 15, 2008.
"This exciting work highlights the potential of expanding the use of the reovirus to include being used as a purging agent during autologous blood stem cell transplants, as well as a treatment for childhood sarcomas," said Dr, Matt Coffey, Chief Scientific Officer of Oncolytics.
A direct link to the abstracts can be found by going here and searching for reovirus.
The first abstract, entitled "Targeting Multiple Myeloma with Oncolytic Viral Therapy" covers preclinical work using reovirus as a purging agent during autologous (harvested from the patient themselves) hematopoietic stem cell transplants for multiple myeloma. The results demonstrated that up to 70% of multiple myeloma cell lines tested showed reovirus sensitivity and reovirus induced cell death mediated through apoptosis. An oral presentation is scheduled to be delivered by Dr. Chandini Thirukkumaran of the Tom Baker Cancer Centre, Calgary, AB on Tuesday, April 15, 2008.
The second abstract, entitled "Radiation in Combination with Reolysin for Pediatric Sarcomas" covers preclinical work using reovirus in combination with radiation in mice implanted with pediatric rhabdomyosarcoma and Ewing's sarcoma tumours. The results demonstrated that the combination of reovirus and radiation significantly enhanced efficacy compared to either treatment alone in terms of tumour regression and event free survival. A poster presentation is scheduled to be delivered by Dr. Pooja Gidwani of the Albert Einstein College of Medicine, Bronx, New York on Tuesday, April 15, 2008.
"This exciting work highlights the potential of expanding the use of the reovirus to include being used as a purging agent during autologous blood stem cell transplants, as well as a treatment for childhood sarcomas," said Dr, Matt Coffey, Chief Scientific Officer of Oncolytics.
A direct link to the abstracts can be found by going here and searching for reovirus.
Tuesday, March 11, 2008
Oncology Biologics Development Primer Materials Released
Oncolytics Biotech Inc. to Present at BioSquare 2008
CALGARY, AB, --- March 10, 2008--- Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY), will present a corporate overview of the Company at the BioSquare 2008 Conference on Thursday, March 13, 2008. The event is being held at the Congress Center in Basel, Switzerland from March 12-14, 2008.
For more information on BioSquare go here.
For more information on BioSquare go here.
Sunday, March 9, 2008
Update on Kenny
Check out Deborah Foster's "When the Family has Cancer" page for an update on Kenny, a patient in Oncolytics Biotech's phase II program.
Saturday, March 8, 2008
Oncolytics Biotech Inc. Reports Highlights and Financial Results for 2007
CALGARY, AB, March 6, 2008 --- Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today reported its financial results for the year ended December 31, 2007.
“2007 was our most productive year to date, marking a significant expansion of the Company’s clinical trial program for REOLYSIN® with Phase II studies and combination drug therapy studies being expanded and initiated,” said Dr. Brad Thompson, President and CEO of Oncolytics. “This activity was supported by further advances in our preclinical development program, manufacturing, and intellectual property.”
“2007 was our most productive year to date, marking a significant expansion of the Company’s clinical trial program for REOLYSIN® with Phase II studies and combination drug therapy studies being expanded and initiated,” said Dr. Brad Thompson, President and CEO of Oncolytics. “This activity was supported by further advances in our preclinical development program, manufacturing, and intellectual property.”
Selected Highlights:
Clinical Trial Results Presented
- Final results from our Phase I U.K. systemic administration trial, and our U.S. Phase I systemic administration trial at ASCO;
- Positive interim results from our U.K. Phase Ia/Ib combination REOLYSIN® and radiation trial;
Clinical Trial Progress
- Commenced patient enrolment in three combination REOLYSIN® and chemotherapy trials in the U.K.;
- Commenced patient enrolment in a U.S. Phase II trial for patients with various sarcomas that have metastasized to the lung;
- U.S. National Cancer Institute (NCI) filed a protocol with the U.S. Food and Drug Administration (FDA) to conduct a Phase II melanoma trial with REOLYSIN®;
- Approval to begin a Phase I combination REOLYSIN® and cyclophosphamide trial in the U.K.;
- In January 2008, the NCI filed a protocol with the U.S. FDA to conduct a Phase I/II ovarian, peritoneal and fallopian tube cancer trial;
- In January 2008, met the criteria to expand to full enrolment of 52 patients in our U.S. Phase II sarcoma trial;
Manufacturing
- Completed scale up of our manufacturing process to the 40-litre level and investigated further increases in scale to the 100-litre level;
Financial and Intellectual Property
- Completed a public offering that added gross proceeds of $13.8 million to our financial reserves; and,
- Secured an additional eight U.S, patents and one Canadian patent, bringing our current total to more than 165 patents issued worldwide;
“We expect 2008 to be an outstanding year as we move ahead with our Phase II program and begin to focus our efforts in the clinical program in key indications,” said Thompson. “With solid preclinical and Phase I results, a scalable manufacturing process, a comprehensive intellectual property portfolio and the financial resources to support our Phase II program, we are well positioned for an exciting and productive 2008.”
View the complete report here.
Saturday, February 23, 2008
Oncolytics Biotech Inc. to Present at Oncology Biologics Development Primer
CALGARY, Alberta, --- February 21, 2008 – Dr. Matt Coffey, Chief Scientific Officer of Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY), will participate as an invited speaker in a session entitled “Case Studies in Gene Therapies” at the Oncology Biologics Development Primer (OBDP) conference on Friday, February 29, 2008. The OBDP was developed by the International Society for Biological Therapy of Cancer (iSBTc) to explore and discuss best practices for worldwide biologics development. The conference runs from February 28-29, 2008 in Gaithersburg, MD.
For more information about the conference, please visit www.isbtc.org and click on “Oncology Biologics Development Primer.”
For more information about the conference, please visit www.isbtc.org and click on “Oncology Biologics Development Primer.”
Tuesday, February 19, 2008
Virus as Viable Drug
"Coincidence or phenomena? The reovirus is Mother Nature's own cancer-killer." Provocative headlines from PharmExec.com.
Read the full article here.
Read the full article here.
Saturday, February 9, 2008
Latest update on Kenny
Kenny, a patient in the San Antonio trials, checks in with some new information:
...this last time, I also had a PET scan (my first one). The results showed “no metabolic activity”, which “suggests” that there may not be any active cancer cells anywhere. Medically speaking, there seems to be little evidence that I have cancer any more...
Exciting indeed. I encourage everyone to keep Kenny in your prayers.
Read the full article here.
...this last time, I also had a PET scan (my first one). The results showed “no metabolic activity”, which “suggests” that there may not be any active cancer cells anywhere. Medically speaking, there seems to be little evidence that I have cancer any more...
Exciting indeed. I encourage everyone to keep Kenny in your prayers.
Read the full article here.
Wednesday, February 6, 2008
Oncolytics Biotech Inc. to Present at Bio CEO & Investor Conference
CALGARY, Alberta, --- February 6, 2008
Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY), will participate as an invited speaker as part of a panel discussion entitled “Breaking Down the Barriers to New Neuro-Oncology Drugs” at the 10th Annual Bio CEO & Investor Conference 2008 on Monday, February 11 at 9:30 a.m. (ET). The conference, which is expected to draw more than 1,000 biotechnology and life sciences investors, will be held at the Waldorf-Astoria Hotel in New York City on February 11-13, 2008.
Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY), will participate as an invited speaker as part of a panel discussion entitled “Breaking Down the Barriers to New Neuro-Oncology Drugs” at the 10th Annual Bio CEO & Investor Conference 2008 on Monday, February 11 at 9:30 a.m. (ET). The conference, which is expected to draw more than 1,000 biotechnology and life sciences investors, will be held at the Waldorf-Astoria Hotel in New York City on February 11-13, 2008.
Monday, February 4, 2008
Oncolytics Biotech Inc. Announces Publication of Research on Combination Reovirus and Radiation Therapy
CALGARY, Canada, February 4 /PRNewswire/
Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) ('Oncolytics') reported today that Dr. Kevin Harrington and his research group at The Institute of Cancer Research, London, U.K. published the results of their work testing combination treatment schedules of reovirus and radiation in human and murine tumour cells in vitro and in vivo. The paper, entitled "Enhanced In vitro and In vivo Cytotoxicity of Combined Reovirus and Radiotherapy" appears online in the February 1, 2008 issue of Clinical Cancer Research.
The effect of different schedules of reovirus and radiotherapy on viral replication and cytotoxicity was tested in vitro and the combination was assessed in three tumour models in vivo. The results demonstrated that combining reovirus and radiotherapy significantly increased cancer cell killing both in vitro and in vivo, particularly in cell lines with moderate susceptibility to reovirus alone.
"Dr. Harrington's work demonstrates convincingly that REOLYSIN® works to enhance the effects of radiation therapy," said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics. "The results of this preclinical research provided strong support for the combination REOLYSIN® and radiation clinical trials we are conducting in the U.K. To date, we have successfully completed enrolment in a Phase Ia/Ib combination REOLYSIN® and radiation trial and are currently enrolling patients in a Phase II trial using this combination".
From the abstract:
Results: Characterization of reovirus cytotoxicity in a panel of cell lines yielded a range of sensitivities. Combined reovirus and radiotherapy yielded statistically significantly increased cytotoxicity, particularly in cell lines with moderate susceptibility to reovirus alone. The enhanced cytotoxicity of the combination occurred independently of treatment sequence or schedule. Radiation did not affect viral replication and only reduced reoviral cytotoxicity after clinically irrelevant single doses (>50 Gy). Combination index analysis revealed synergy between radiation (3-10 Gy) and reovirus at multiplicities of infection between 0.001 and 1. Combination treatment significantly increased apoptosis in tumor cells relative to either single-agent treatment. In vivo studies using xenograft and syngeneic tumors showed enhanced activity of the combination relative to reovirus or radiation alone (P <>
View the complete abstract here.
Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) ('Oncolytics') reported today that Dr. Kevin Harrington and his research group at The Institute of Cancer Research, London, U.K. published the results of their work testing combination treatment schedules of reovirus and radiation in human and murine tumour cells in vitro and in vivo. The paper, entitled "Enhanced In vitro and In vivo Cytotoxicity of Combined Reovirus and Radiotherapy" appears online in the February 1, 2008 issue of Clinical Cancer Research.
The effect of different schedules of reovirus and radiotherapy on viral replication and cytotoxicity was tested in vitro and the combination was assessed in three tumour models in vivo. The results demonstrated that combining reovirus and radiotherapy significantly increased cancer cell killing both in vitro and in vivo, particularly in cell lines with moderate susceptibility to reovirus alone.
"Dr. Harrington's work demonstrates convincingly that REOLYSIN® works to enhance the effects of radiation therapy," said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics. "The results of this preclinical research provided strong support for the combination REOLYSIN® and radiation clinical trials we are conducting in the U.K. To date, we have successfully completed enrolment in a Phase Ia/Ib combination REOLYSIN® and radiation trial and are currently enrolling patients in a Phase II trial using this combination".
From the abstract:
Results: Characterization of reovirus cytotoxicity in a panel of cell lines yielded a range of sensitivities. Combined reovirus and radiotherapy yielded statistically significantly increased cytotoxicity, particularly in cell lines with moderate susceptibility to reovirus alone. The enhanced cytotoxicity of the combination occurred independently of treatment sequence or schedule. Radiation did not affect viral replication and only reduced reoviral cytotoxicity after clinically irrelevant single doses (>50 Gy). Combination index analysis revealed synergy between radiation (3-10 Gy) and reovirus at multiplicities of infection between 0.001 and 1. Combination treatment significantly increased apoptosis in tumor cells relative to either single-agent treatment. In vivo studies using xenograft and syngeneic tumors showed enhanced activity of the combination relative to reovirus or radiation alone (P <>
View the complete abstract here.
Thursday, January 31, 2008
Oncolytics Biotech Inc. Proceeds to Full Enrolment in U.S. Phase II Sarcoma Clinical Trial
CALGARY, AB, --- January 31, 2008 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that it has met the initial criteria to proceed to full enrolment in its U.S. Phase II trial to evaluate the intravenous administration of REOLYSIN® in patients with various sarcomas that have metastasized to the lung.
According to the trial protocol, to proceed to full enrolment of 52 patients, Oncolytics had to demonstrate that at least one patient in the first 38 patients treated experienced a complete or partial response, or stable disease for greater than six months. The third patient treated in the study was demonstrated to have stable disease by RECIST criteria for more than six months as measured by CT scan. A PET scan taken at the same time showed that any residual mass was metabolically inert.
A total of 12 patients have received REOLYSIN® treatment to date, with five remaining on study. All 12 patients have been treated at the Cancer Therapy and Research Center, University of Texas Health Science Center in San Antonio, Texas (CTRC at UTHSCSA).
“We are very pleased to proceed to the second stage of the REOLYSIN® study,” said Dr. Monica Mita, Principal Investigator at CTRC at UTHSCSA. “This unique targeted compound has met our expectations so far in terms of both tolerability and efficacy endpoints and we feel it is very important to continue to offer this agent to our patients.”
“While still early, these are very encouraging results,” said Dr. Karl Mettinger, Chief Medical Officer of Oncolytics. “There are few treatment options for patients with bone or soft tissue cancers, and we are pleased that the trial participants appear to be benefiting from REOLYSIN® treatment.”
Patients are expected to be enrolled at three additional sites, which include the Montefiore Medical Center/Albert Einstein College of Medicine in the Bronx, New York, the University of Michigan Comprehensive Cancer Center in Ann Arbor, Michigan, and the Mayo Clinic in Rochester, Minnesota.
The trial (REO 014) is a Phase II, open-label, single agent study whose primary objective is to measure tumour responses and duration of response, and to describe any evidence of antitumour activity of intravenous, multiple dose REOLYSIN® in patients with bone and soft tissue sarcomas metastatic to the lung. REOLYSIN® is delivered intravenously to patients at a dose of 3x1010 TCID50 for five consecutive days. Patients may receive additional five-day cycles of therapy every four weeks for a maximum of eight cycles. Up to 52 patients will be enrolled in the study.
Eligible patients must have a bone or soft tissue sarcoma metastatic to the lung deemed by their physician to be unresponsive to or untreatable by standard therapies. These include patients with osteosarcoma, Ewing sarcoma family tumours, malignant fibrous histiocytoma, synovial sarcoma, fibrosarcoma and leiomyosarcoma.
According to the trial protocol, to proceed to full enrolment of 52 patients, Oncolytics had to demonstrate that at least one patient in the first 38 patients treated experienced a complete or partial response, or stable disease for greater than six months. The third patient treated in the study was demonstrated to have stable disease by RECIST criteria for more than six months as measured by CT scan. A PET scan taken at the same time showed that any residual mass was metabolically inert.
A total of 12 patients have received REOLYSIN® treatment to date, with five remaining on study. All 12 patients have been treated at the Cancer Therapy and Research Center, University of Texas Health Science Center in San Antonio, Texas (CTRC at UTHSCSA).
“We are very pleased to proceed to the second stage of the REOLYSIN® study,” said Dr. Monica Mita, Principal Investigator at CTRC at UTHSCSA. “This unique targeted compound has met our expectations so far in terms of both tolerability and efficacy endpoints and we feel it is very important to continue to offer this agent to our patients.”
“While still early, these are very encouraging results,” said Dr. Karl Mettinger, Chief Medical Officer of Oncolytics. “There are few treatment options for patients with bone or soft tissue cancers, and we are pleased that the trial participants appear to be benefiting from REOLYSIN® treatment.”
Patients are expected to be enrolled at three additional sites, which include the Montefiore Medical Center/Albert Einstein College of Medicine in the Bronx, New York, the University of Michigan Comprehensive Cancer Center in Ann Arbor, Michigan, and the Mayo Clinic in Rochester, Minnesota.
The trial (REO 014) is a Phase II, open-label, single agent study whose primary objective is to measure tumour responses and duration of response, and to describe any evidence of antitumour activity of intravenous, multiple dose REOLYSIN® in patients with bone and soft tissue sarcomas metastatic to the lung. REOLYSIN® is delivered intravenously to patients at a dose of 3x1010 TCID50 for five consecutive days. Patients may receive additional five-day cycles of therapy every four weeks for a maximum of eight cycles. Up to 52 patients will be enrolled in the study.
Eligible patients must have a bone or soft tissue sarcoma metastatic to the lung deemed by their physician to be unresponsive to or untreatable by standard therapies. These include patients with osteosarcoma, Ewing sarcoma family tumours, malignant fibrous histiocytoma, synovial sarcoma, fibrosarcoma and leiomyosarcoma.
Tuesday, January 29, 2008
Oncolytics Biotech Inc. Announces Issuance of 8th Canadian Patent
CALGARY, AB --- January 29, 2008 - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) (“Oncolytics”) has been granted Canadian Patent 2,408,251 entitled “Clearance of Neoplastic Cells from Mixed Cellular Compositions using Viruses.” The claims describe methods of selectively removing cancer cells ex vivo from blood stem cells and other organs using various viruses including modified vaccinia viruses, herpes simplex viruses, parapoxviruses and adenoviruses.
“This patent broadens coverage in the area of using other modified oncolytic viruses to purge contaminating cancer cells from stem cell preparations used for transplants,” said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics.
Monday, January 28, 2008
Oncolytics Biotech in Business Week Magazine
Siccing a Virus on the Deadliest Cancers
The February 4th edition of BusinessWeek magazine includes a feature on Oncolytics Biotech, Inc. and the NCI ovarian trials called: Siccing a Virus on the Deadliest Cancers.
I think a mention in such a high profile magazine speaks to the importance of these trials and the investigation of Reolysin with ovarian cancer.
Read the article here.
The February 4th edition of BusinessWeek magazine includes a feature on Oncolytics Biotech, Inc. and the NCI ovarian trials called: Siccing a Virus on the Deadliest Cancers.
I think a mention in such a high profile magazine speaks to the importance of these trials and the investigation of Reolysin with ovarian cancer.
Read the article here.
Wednesday, January 23, 2008
Article: Harmless Reovirus is a Cancer Killer
For those of you who missed this like I did, read the article from business week here regarding the NCI Phase I/II. I think of all the trials thus far this is the one I'm most personally interested in following.
Don't forget to scroll down for this morning's press release.
Don't forget to scroll down for this morning's press release.
Oncolytics Biotech Inc. Announces Issuance of 7th Canadian Patent
1/23/2008 9:43:18 AM ET
CALGARY, AB --- January 23, 2008 -
Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) (“Oncolytics”) has been granted Canadian Patent 2,508,238 entitled “Reovirus for the Treatment of Neoplasia.” The claims describe using various human reoviruses to treat cancers that have inactivated or deleted PKR, a host cellular protein responsible for preventing virus replication within a cell.
“This is a broad patent that expands our coverage in Canada in the area of cancers with inactivated PKR,” said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics. “Oncolytics secured a similar patent in the U.S. in late 2007.”
About Oncolytics Biotech Inc.Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics’ clinical program includes a variety of Phase I and Phase II human trials using REOLYSIN®, its proprietary formulation of the human reovirus, alone and in combination with radiation or chemotherapy. For further information about Oncolytics please visit www.oncolyticsbiotech.com
CALGARY, AB --- January 23, 2008 -
Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) (“Oncolytics”) has been granted Canadian Patent 2,508,238 entitled “Reovirus for the Treatment of Neoplasia.” The claims describe using various human reoviruses to treat cancers that have inactivated or deleted PKR, a host cellular protein responsible for preventing virus replication within a cell.
“This is a broad patent that expands our coverage in Canada in the area of cancers with inactivated PKR,” said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics. “Oncolytics secured a similar patent in the U.S. in late 2007.”
About Oncolytics Biotech Inc.Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics’ clinical program includes a variety of Phase I and Phase II human trials using REOLYSIN®, its proprietary formulation of the human reovirus, alone and in combination with radiation or chemotherapy. For further information about Oncolytics please visit www.oncolyticsbiotech.com
Thursday, January 3, 2008
Oncolytics Biotech Inc. Announces Filing of Phase 1/2 Clinical Trial with REOLYSIN®
CALGARY, AB, --- January 3, 2008 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that the U.S. National Cancer Institute (NCI) has filed a protocol with the U.S. Food and Drug Administration (FDA) for a Phase 1/2 clinical trial for patients with metastatic ovarian, peritoneal or fallopian tube cancers using concurrent systemic and intraperitoneal administration of REOLYSIN®, Oncolytics’ proprietary formulation of the human reovirus. The NCI is sponsoring the trial under its Clinical Trials Agreement with Oncolytics, while Oncolytics will provide clinical supplies of REOLYSIN®.
The trial, which is being carried out at The Ohio State University Comprehensive Cancer Center, is expected to enroll up to 70 patients with metastatic ovarian, peritoneal or fallopian tube cancers.
These cancer indications were selected after comprehensive preclinical studies carried out by the NCI indicated the reovirus can kill ovarian cancer cells.
The American Cancer Society estimates that more than 22,000 women will be diagnosed with ovarian cancer in the U.S. in 2007, and more than 15,000 will die from it.
The trial, which is being carried out at The Ohio State University Comprehensive Cancer Center, is expected to enroll up to 70 patients with metastatic ovarian, peritoneal or fallopian tube cancers.
These cancer indications were selected after comprehensive preclinical studies carried out by the NCI indicated the reovirus can kill ovarian cancer cells.
The American Cancer Society estimates that more than 22,000 women will be diagnosed with ovarian cancer in the U.S. in 2007, and more than 15,000 will die from it.
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