US NCI Initiates Phase II Enrollment for Reolysin
Oncolytics Biotech has announced that the US National Cancer Institute, part of the National Institutes of Health, has started enrollment in a Phase II clinical trial for patients with metastatic melanoma using systemic administration of Reolysin, Oncolytics’s proprietary formulation of the human reovirus.
The trial is being carried out by the Mayo phase two consortium under the National Cancer Institute’s (NCI’s) clinical trials agreement with Oncolytics, while Oncolytics will provide clinical supplies of Reolysin.
The primary objectives of the study are to assess the antitumor 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 3×10(10) TCID(50) per day on days one to five 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.