Oncolytics Biotech Inc.'s Reolysin Exceeds Primary Statistical Endpoint in U.S. Phase 2 Sarcoma Study

CALGARY, Dec. 11 - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that it has exceeded the primary statistical endpoint in its multi-centre Phase 2 clinical trial to evaluate the intravenous administration of REOLYSIN(R) in patients with various sarcomas that have metastasized to the lung.

   

"The proportion of patients on study with significant, durable, clinically meaningful responses is highly encouraging," said Dr. Frank Giles, Director of the Institute of Drug Development, the Cancer Therapy and Research Center at the University of Texas Health Science Center, San Antonio, Texas. "This very novel agent has delivered a positive answer to its first critical

efficacy question."

   

To meet the statistical endpoint, at least three out of 52 patients had to experience stabilization of disease or better for more than six months. Of 33 evaluable patients treated to date, five have experienced stable disease for periods greater than six months, including one patient who has maintained stable disease for more than 16 months. An additional 10 patients have experienced stable disease for periods ranging from three to six cycles (cycle = 28 days). Twelve patients are continuing on study, including the five patients who have been stable for more than six months.

 

Tumour Type                

Months on Study        

Best Response

Synovial sarcoma           

16(*)                  

SD

Ewing's sarcoma             

9(*)                  

SD

Osteosarcoma 

9(*)                   

SD (tumour resection after cycle 4)

Chordoma 

6(*)                  

SD

Unspecified Spindle Cell    

6(*)                  

SD

(*) patients still on study

  

"We are very pleased to have met the statistical endpoint in our first U.S. Phase 2 study, particularly in such a difficult-to-treat form of cancer," said Dr. Brad Thompson, President and CEO of Oncolytics. "The interim data indicate that REOLYSIN(R) is active in various types of metastatic sarcoma, and that late-stage clinical trials are justified."

   

Sarcomas are malignant tumors growing from connective tissues, such as cartilage, fat, muscle, or bone. According to the American Cancer Society, only 16.3% of patients with distant spread of sarcoma live longer than five years. There is an unmet medical need for effective treatments for patients with this type of disease.

   

Clinical Trial Design

   

The trial (REO 014) is a Phase 2, open-label, single agent study whose primary objective is to measure tumour responses and duration of response, and to describe any evidence of antitumour activity of intravenous, multiple dose REOLYSIN(R) in patients with bone and soft tissue sarcomas metastatic to the lung. REOLYSIN(R) is delivered intravenously to patients at a dose of 3x10(10) TCID(50) for five consecutive days, every 28 days. Up to 52 patients will be enrolled in the study.

   

Eligible patients must have a bone or soft tissue sarcoma metastatic to the lung deemed by their physician to be unresponsive to or untreatable by standard therapies. These include patients with osteosarcoma, Ewing sarcoma family tumours, malignant fibrous histiocytoma, synovial sarcoma, fibrosarcoma and leiomyosarcoma.

    

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/II 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

   

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.S. Phase II sarcoma 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, except as required by applicable laws.

 

<!-- RELBODY END --><!-- RELCONTACT START -->For further information: Oncolytics Biotech Inc., Cathy Ward, 210, 1167 Kensington Cr NW, Calgary, Alberta, T2N 1X7, Tel: (403) 670-7377, Fax: (403) 283-0858, cathy.ward@oncolytics.ca; The Equicom Group, Nick Hurst, 325, 300 5th Ave. SW, Calgary, AB, T2P 3C4, Tel: (403) 538-4845, Fax: (403) 237-6916, nhurst@equicomgroup.com; The Investor Relations Group, Erika Moran, 11 Stone St, 3rd Floor, New York, NY, 10004, Tel: (212) 825-3210, Fax: (212) 825-3229, emoran@investorrelationsgroup.com

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Posted: December 2008

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