Oncolytics Biotech REOLYSIN® Exceeds Primary Statistical Endpoint in U.S. Phase 2 Sarcoma Study
News Dec 15, 2008
Oncolytics Biotech Inc. has announced that it has exceeded the primary statistical endpoint in its multi-centre Phase 2 clinical trial to evaluate the intravenous administration of REOLYSIN® 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. Twelve patients are continuing on study, including the five patients who have been stable for more than six months.
"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® is active in various types of metastatic sarcoma, and that late-stage clinical trials are justified."
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® in patients with bone and soft tissue sarcomas metastatic to the lung. REOLYSIN® 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.
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