Oncolytics Biotech Inc. Starts Patient Enrolment in U.K. Combination REOLYSIN(R)/Gemcitabine Trial
CALGARY, June 11 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) has commenced patient enrolment in its U.K. clinical trial to evaluate the anti-tumour effects of systemic administration of REOLYSIN(R) in combination with gemcitabine (Gemzar(R)) in patients with advanced cancers including pancreatic, lung and ovarian. The combination of reovirus and gemcitabine has been shown in preclinical studies to be more effective than gemcitabine or reovirus alone at killing certain cancer cell lines.
"Exciting preclinical work conducted in collaboration with Cornell University in New York provided the rationale for this human trial," said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics. "The data gathered in this trial and in our other ongoing trials in the U.K. and the U.S. is expected to further define the optimal path to product registration."
The principal investigators are Dr. Johann de Bono of The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, and Professor Jeff Evans of the University of Glasgow and the Beatson Oncology Centre in Glasgow, Scotland.
The trial (REO 009) has two components. The first is an open-label, dose-escalating, non-randomized study of REOLYSIN(R) given intravenously with gemcitabine every three weeks. A standard dosage of gemcitabine will be delivered with escalating dosages of REOLYSIN(R) intravenously. A maximum of three cohorts will be enrolled in the REOLYSIN(R) dose escalation portion. The second component of the trial will immediately follow and will include the enrolment of a further 12 patients at the maximum dosage of REOLYSIN(R) in combination with a standard dosage of gemcitabine. This trial is one of three expected to begin in 2007 that will examine the role of REOLYSIN(R) in combination with standard chemotherapeutics.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours such as pancreatic, 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(R) when administered in combination with gemcitabine. 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 280,000 people are diagnosed annually with pancreatic, lung and ovarian cancers.
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(R), 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
For more information about gemcitabine (Gemzar(R)) please visit www.gemzar.com
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company's expectations related to the U.K. combination REOLYSIN(R)/gemcitabine clinical trial and the Company's belief as to the potential of REOLYSIN(R) as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN(R) as a cancer treatment, the tolerability of REOLYSIN(R) outside a controlled test, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize REOLYSIN(R), uncertainties related to the research and development of pharmaceuticals and uncertainties related to the regulatory process. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements.
SOURCE Oncolytics Biotech Inc.
Released June 11, 2007