Oncolytics Biotech Proceeds To Initiate U.S. Phase II Sarcoma Clinical Trial
Oncolytics Biotech Inc. announced that subsequent to the regulatory review period for this submission, it is proceeding with a Phase II trial to evaluate the intravenous administration of REOLYSIN in patients with various sarcomas that have metastasized to the lung.
The Principal Investigators are Dr. Glenn S. Kroog of the Montefiore Medical Center/Albert Einstein College of Medicine in the Bronx, New York, Dr. Laurence H. Baker of the University of Michigan Comprehensive Cancer Center in Ann Arbor, and Dr. Monica Mita of the Cancer Therapy and Research Center, Institute for Drug Development in San Antonio, Texas.
"This multi-centre, Phase II trial follows the successful completion of systemic administration trials with REOLYSIN(R) in the U.K. and the U.S.," said Dr. Karl Mettinger, Chief Medical Officer of Oncolytics. "This trial is the second in a series of Phase II trials the Company has planned for this year, and represents yet another step forward in the Company's clinical development strategy for REOLYSIN(R). We are excited to expand our clinical program to specifically include patients with sarcomas."
The trial (REO 014) is a Phase II, 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) will be given intravenously to patients at a dose of 3x10(10) TCID(50) for five consecutive days. Patients may receive additional five-day cycles of therapy every four weeks for a maximum of eight cycles. 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.