Oncolytics Biotech Inc. Announces Commencement of Solicitation Process for Clinical Trials
Oncolytics Biotech Inc. announced that the cancer therapy Evaluation Program (CTEP), part of the U.S. National Cancer Institute ("NCI"), has issued a solicitation for Letters of Intent with respect to the conduct of two human clinical trials using REOLYSIN(R), a proprietary formulation of the human reovirus being developed as a potential cancer therapeutic.
CTEP is soliciting proposals for a Phase II study of REOLYSIN(R) administered systemically in patients with melanoma. The dosage and dosing regimen to be used in the study will be determined based on data derived from ongoing U.K. and U.S. Phase I systemic administration studies being conducted by Oncolytics.
CTEP is also soliciting proposals for a Phase I/II study of REOLYSIN(R) co-administered both systemically and intraperitoneally (IP) in patients with ovarian cancer. The purpose of the Phase I portion of the trial is to determine the Maximum Tolerated Dose (MTD) of REOLYSIN(R) given by IP administration in combination with a constant systemic dose and dosing regimen.
Oncolytics will provide REOLYSIN(R) for all clinical trials conducted and sponsored by the NCI under a Clinical Trials Agreement (CTA). The NCI initially approved REOLYSIN(R) for collaborative development after an analysis of preclinical, GLP toxicology and clinical data. Since the CTA was approved, Oncolytics and the NCI have worked together to select cancer indications and suitable development programs.
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