BioVex Commences OncoVEX (GM-CSF) Phase 3 Trial in Metastati...( WOBURN Mass. April 14 /- BioVex Inc...)

WOBURN, Mass., April 14 /PRNewswire/ -- BioVex Inc, a company developing next generation biologics for the treatment and prevention of cancer and infectious disease, announced today that its OPTiM (OncoVEX Pivotal Trial in Melanoma) Phase 3 study with OncoVEX (GM-CSF) in previously treated patients with Stage III and Stage IV melanoma had initiated. The study has commenced recruiting patients in the U.S. with sites in the United Kingdom, Germany and Australia due to open later in the year. Further details on this study can be found at www.oncovexgmcsf.com and at www.clinicaltrials.gov.

Dr Robert Coffin, Founder and Chief Technology Officer of BioVex Inc said:

"The treatment options for patients with recurrent or metastatic melanoma are currently very limited, with no therapy being approved or recognized to be effective in the second line setting and beyond. Currently, there are also very few late stage or pivotal clinical studies available for patients who have failed first line therapy. The initiation of this study, following the highly encouraging data generated in Phase 2, is therefore a significant milestone on the path towards meeting this major unmet need, and towards the approval of OncoVEX (GM-CSF) in this first indication."

OPTiM Phase 3 Trial Design

The OPTiM trial is a multi-national, open label, randomized Phase 3 study designed to assess the efficacy and safety of treatment with OncoVEX (GM-CSF) as compared to subcutaneously administered GM-CSF in patients with unresectable stage III (b-c) and Stage IV (M1a-c) disease. Patients will have received at least one prior therapy for active disease which includes any type of therapy including investigational drugs. A total of 360 patients will be enrolled (240 to
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