CALGARY, Alberta, January 24, 2002 -- Oncolytics Biotech Inc. (TSE: ONC, NASDAQ: ONCY) (‘Oncolytics’) has filed a Clinical Trial Application (CTA) with Health Canada to initiate a Phase I/II clinical trial investigating the use of REOLYSIN® to treat patients with recurrent malignant glioma, the most aggressive form of brain cancer. Oncolytics also intends to file an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) and conduct this study at centers in both Canada and the US.
“We believe that REOLYSIN® has the potential to be an important component of the treatment for this extremely aggressive cancer,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We have not seen any severe adverse effects after direct administration of REOLYSIN® into the brains of two animal species. In addition to this excellent safety profile, tumour regression and survival benefits have been demonstrated in animal models from a single intracerebral injection of REOLYSIN®.”
The final design of this clinical program evaluating the safety and efficacy of intracerebral administration of REOLYSIN® will be disclosed after it has been discussed with and approved by Health Canada and the FDA. In the dose escalation or Phase I portion of the study, patients with a variety of recurrent malignant gliomas will be enrolled. In the Phase II portion of the program, patients with recurrent glioblastoma multiforme, the most aggressive glioma, will be treated at the dose selected on the basis of the dose escalation study.
Dr. Peter Forsyth and his research group with the Alberta Cancer Board and the University of Calgary published the results of their research in the June 20, 2001 issue of the Journal of the National Cancer Institute (see Oncolytics press release dated June 19, 2001). Mice with brain tumours were treated with a single injection of REOLYSIN®. Benefits included complete tumour regression in 20 of 23 treated animals, a statistically significant increase in survival, an increase in body weight and no impairment of their cognitive functions. REOLYSIN® killed cancer cells from 19 of 24 established glioma cell lines and from all nine glioma surgical specimens.
The annual incidences of malignant brain tumours in North American and Europe is approximately 40,000 patients per year. The standard treatment for patients with newly diagnosed malignant gliomas is surgery, followed by radiation therapy and sometimes systemic chemotherapy. Because the surgery must be delicate and the tumours are invasive, local tumour recurrence is almost inevitable. The treatment options for patients with recurrent disease are limited, including additional surgery that may be combined with local chemotherapy.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of the human reovirus (REOLYSIN®) as a potential cancer therapeutic. Oncolytics’ researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells derived from many types of cancer including breast, prostate, pancreatic and brain tumours. Research has also yielded successful cancer treatment results in a number of animal models. Interim 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®.
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 intention to file an Investigational New Drug (IND) application, the Company’s belief as to the potential of REOLYSIN® as a component of the treatment for recurrent malignant Glioma and other cancers, the belief that the Ras pathway has broad potential in the treatment of many cancers; and the Company’s expectations as to the timing and outcomes of the malignant glioma trial, 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® as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize REOLYSIN®, 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.
FOR FURTHER INFORMATION PLEASE 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
www.oncolyticsbiotech.com
For Canada:
The Equicom Group Inc.
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 Dian Griesel, Ph.D.
50 Pine Street, 6th Floor
New York, NY 10005
Tel: 212.825.3210
Fax: 212.825.3229
theproteam@aol.com
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