BioVex Agrees SPA With the FDA for a Pivotal Study With OncoVEX(GM-CSF) in Metastatic Melanoma and Announces Presentation of Phase II Resul...( FDA agrees to first SPA...),Health

FDA agrees to first SPA for an oncolytic product

WOBURN, Mass., April 22 /PRNewswire/ -- BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase III clinical trial evaluating its lead product, OncoVEX(GM-CSF) in previously treated patients with metastatic melanoma. The agreement was made under the Special Protocol Assessment (SPA) procedure.

BioVex is currently concluding a 50-patient Phase II trial for OncoVEX(GM-CSF) as stand alone therapy in patients with unresectable Stage IIIc and Stage IV metastatic melanoma. The trial was designed to measure overall objective response, which is defined as a complete response (CR), where disease is completely eliminated, or partial response (PR), where there is a >30% reduction in disease burden. Interim results from the study demonstrated a highly encouraging rate of durable objective response with multiple patients with metastatic disease at enrollment having been declared disease free following therapy. The full study has been accepted for oral presentation at ASCO on June 1st where the results will be presented.

The Phase III study design agreed with the FDA follows directly from the study design successfully employed in Phase II. The Phase III study will also enroll previously treated patients with unresectable stage IIIc and stage IV disease using OncoVEX(GM-CSF) as monotherapy. The primary efficacy endpoint will also be response rate-based; the primary objective being to demonstrate a statistically significant increase in the rate of objective responses maintained for six months or more, in comparison to control therapy (subcutaneously administered(GM-CSF). The study is intended to enroll 360 evaluable patients randomized such that 240 patients receive OncoVEX(GM-CSF) and 120 patients receive contro
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