Oncolytics® Biotech Inc. Completes Patient Enrolment in U.S. Phase 2 Sarcoma Study
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Oncolytics Biotech Inc. has announced that it has successfully completed patient enrollment 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. A total of 52 patients have been enrolled in the trial.
"We are extremely pleased to have had the opportunity to participate in this study," said Dr. Monica Mita, principal investigator at the Institute of Drug Development (IDD), the Cancer Therapy & Research Center at the University of Texas Health Science Center, (UTHSC), San Antonio, Texas.
"REOLYSIN is very well tolerated and a number of patients have derived clinical benefit. Based on the study results, which will be updated and presented at ASCO this year, further studies are planned in patients with sarcoma."
The primary statistical endpoint of the trial was met in late 2008. To meet the endpoint, at least three out of 52 patients had to experience stabilization of disease or better for more than six months. Of the 33 patients evaluable at that time, five had experienced stable disease for periods greater than six months, including one patient who had maintained stable disease for more than 16 months.
An additional 10 patients had experienced stable disease for periods ranging from three to six cycles (cycle = 28 days). Updated results are scheduled to be presented May 30, 2009 at the American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, Florida.
"We are extremely pleased to have had the opportunity to participate in this study," said Dr. Monica Mita, principal investigator at the Institute of Drug Development (IDD), the Cancer Therapy & Research Center at the University of Texas Health Science Center, (UTHSC), San Antonio, Texas.
"REOLYSIN is very well tolerated and a number of patients have derived clinical benefit. Based on the study results, which will be updated and presented at ASCO this year, further studies are planned in patients with sarcoma."
The primary statistical endpoint of the trial was met in late 2008. To meet the endpoint, at least three out of 52 patients had to experience stabilization of disease or better for more than six months. Of the 33 patients evaluable at that time, five had experienced stable disease for periods greater than six months, including one patient who had maintained stable disease for more than 16 months.
An additional 10 patients had experienced stable disease for periods ranging from three to six cycles (cycle = 28 days). Updated results are scheduled to be presented May 30, 2009 at the American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, Florida.
