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.
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