BioVex to Report Phase II Clinical Trial Results of OncoVEX GM-CSF in Metastatic Melanoma at the 2008 American Society of Clinical Oncolo...( WOBURN Mass. May 16 /- BioVex Inc...),Health

WOBURN, Mass., May 16 /PRNewswire/ -- BioVex Inc, a biotechnology company developing clinical stage products in oncology and infectious disease, announced today that the abstract describing the interim results from its Phase II clinical trial of OncoVEX GM-CSF in advanced metastatic melanoma is now available at the American Society of Clinical Oncology (ASCO) website located at http://www.asco.org. A summary of the abstract which describes the data as of the submission date to ASCO in January 2008 is provided below.

Senior clinical investigator, Neil N. Senzer, M.D., will present up-to-date results of the abstract entitled "Phase II clinical trial with a second generation, GM-CSF encoding, oncolytic herpes virus in unresectable metastatic melanoma," at the 2008 ASCO Annual Meeting in Chicago, IL on Sunday, June 1 at 9:30am EDT during the melanoma conference session.

A summary of the abstract follows:

Background: OncoVEX GM-CSF is a second generation oncolytic herpes simplex virus (HSV) which encodes GM-CSF. OncoVEX GM-CSF had previously been shown to be well tolerated in a phase I clinical trial in patients with a range of tumor types, in which anti-tumor effects were seen in both injected and un-injected tumors.

Phase II Study Design: Single-arm monotherapy in up to 50 patients with unresectable stage IIIc/IV metastatic melanoma.

End Points: The trial was designed to measure overall objective response, which is defined as a complete response, where disease is completely eliminated, or partial response, where there is a >30% reduction in disease burden. The target efficacy endpoint detailed in the Phase II protocol and agreed upon with the FDA was to achieve two objective responses or stable disease >2 months.

Interim Results: At the time of the abstract submission, 40 patients had been enrolled of whom 31 were evaluable. 81% had stage IV disease. With respect to systemi
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