U.S. NCI Starts Enrolment in Phase 2 Systemic Melanoma Clinical Trial with REOLYSIN®
News Aug 14, 2008
Oncolytics Biotech Inc. has 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®, 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®. 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® in patients with metastatic malignant melanoma, as well as the safety profile of REOLYSIN®. Secondary objectives include assessment of progression free survival and overall survival.
Patients will receive systemic administration of REOLYSIN® at a dose of 3x10(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.