CALGARY, Feb. 27 /PRNewswire-FirstCall/ -- Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) provided a final update today on its technical clinical study evaluating the efficacy and safety of REOLYSIN(R) for the treatment of T2 prostate cancer.
"This clinical trial has met its histopathological objective of showing that REOLYSIN(R) selectively infects and kills tumour cells in humans without damaging adjacent healthy tissue," said Dr. Brad Thompson, Oncolytics' President and CEO. "The data generated was helpful in gaining approval to commence systemic administration studies. Our clinical program for REOLYSIN(R) will focus on the initiation of a systemic delivery clinical trial, our collaborative program with the US National Cancer Institute and our other local delivery studies."
Oncolytics previously reported results from an interim assessment of this clinical study (March 31, 2003). There was evidence of viral activity in five of six patients and there were no safety concerns, from either a clinical or histopathological perspective, in all six patients. The preliminary data showed clear histopathological evidence of apoptotic tumour cell death, one measure of viral activity, in four of the six patients. In a fifth patient, the PSA level dropped by 53% and the prostate gland shrank by 67% from just prior to treatment to the time of surgical removal. There was no evidence of viral activity in the sixth patient. In all six patients, there was no histopathological evidence of any viral effect on healthy prostatic tissue. Additional histopathological analysis has demonstrated immune cell infiltration (B and T cells) into virus infected tumour mass. This infiltration was not noted in adjacent normal tissue. Further histopathological analysis including microarray (a measure of gene expression) is currently being conducted. Information obtained in these studies is intended to be utilized in future systemic studies to assess optimal dosing and response.
The T2 prostate cancer trial was intended to evaluate the safety and histopathological efficacy of intra-tumoural administration of REOLYSIN(R) for the treatment of cancer that is restricted to the prostate gland. Patients received a single injection of REOLYSIN(R) and were monitored for approximately three weeks, at which time the prostate was surgically removed. The primary efficacy endpoint was the response rate as measured by pathological examination of the tumour.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN(R), its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics' researchers have demonstrated that the reovirus is able to selectively kill human cancer cells in vitro that are derived from many types of cancer, including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that there were no toxicology-related issues with the administration of the reovirus, and that the reovirus demonstrated activity in tumours injected with REOLYSIN(R).
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 statements regarding the Company's belief as to the implications of the results of the prostate study as they relate to the outcome of future clinical trials and the Company's expectations 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 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, uncertainties related to the regulatory process and general changes to the economic environment. 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.
Oncolytics Biotech Inc.CONTACT: For Canada: Oncolytics Biotech Inc., Dr. Brad Thompson,210, 1167 Kensington Cr NW, Calgary, Alberta, T2N 1X7, Tel: (403) 670-7377,Fax: (403) 283-0858, http://www.oncolyticsbiotech.com/; For Canada: The Equicom Group,Joanna Longo, 20 Toronto Street, Toronto, Ontario, M5C 2B8,Tel: (416) 815-0700 ext. 233, Fax: (416) 815-0080, jlongo@equicomgroup.com;For United States: The Investor Relations Group, Gino De Jesus or DianGriesel, Ph.D., 11 Stone St, 3rd Floor, New York, NY 10004, T: (212) 825-3210,F: (212) 825-3229, mail@investorrelationsgroup.com
