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.
Showing posts with label Press Release. Show all posts
Showing posts with label Press Release. Show all posts
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®.
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 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.
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 16, 2008
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.
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