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news.BioVex has announced that the FDA has approved the design of a single, pivotal, Phase III clinical trial evaluating its lead product, OncoVEX in previously treated patients with metastatic melanoma.
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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 control.
The pivotal study is expected to commence in the first quarter of 2009, with a potential projected BLA filing in late 2010. BioVex is currently commissioning its GMP manufacturing facility in Woburn, Massachusetts, which is intended to provide product for Phase III studies and launch.