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.
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