U.S. NCI Starts Enrolment In Phase 2 Systemic Melanoma Clinical Trial With REOLYSIN(R)
August 13th, 2008 | by admin |Oncolytics Biotech Inc. (”Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced that the U.S. National Cancer Institute (NCI), part of the National Institutes of Health, has started enrolment in a Phase 2 clinical trial for patients with metastatic melanoma using systemic administration of REOLYSIN(R), Oncolytics’ proprietary formulation of the human reovirus. The trial is being carried out by the Mayo Phase 2 Consortium under the NCI’s Clinical Trials Agreement with Oncolytics, while Oncolytics will provide clinical supplies of REOLYSIN(R). The Principal Investigator is Dr. Evanthia Galanis of the Mayo Clinic Cancer Center.
The primary objectives of the study are to assess the antitumour effects of REOLYSIN(R) in patients with metastatic malignant melanoma, as well as the safety profile of REOLYSIN(R). Secondary objectives include assessment of progression free survival and overall survival.
Patients will receive systemic administration of REOLYSIN(R) at a dose of 3×10(10) TCID(50) per day on days 1-5 of each 28 day cycle, and patients may receive up to 12 cycles of treatment. The trial is expected to enroll up to 47 patients with metastatic melanoma.
Approximately 60,000 people are diagnosed with melanoma in the U.S. every year.
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 http://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. NCI Phase 2 systemic administration clinical trial for patients with metastatic melanoma, 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.
Oncolytics Biotech Inc.
http://www.oncolyticsbiotech.com
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