BioVex Reports Positive Phase II Clinical Trial Results of OncoVEX GM-CSF in Metastatic Melanoma at the 2008 American Society of Clinical Oncolo... ( CHICAGO June 1 /- BioVex Inc a bi...)

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BioVex Reports Positive Phase II Clinical Trial Results of OncoVEX GM-CSF in Metastatic Melanoma at the 2008 American Society of Clinical Oncology Meeting

Date:6/1/2008

CHICAGO, June 1 /PRNewswire/ -- BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, today announced positive results from its Phase II clinical trial of OncoVEX GM-CSF, an oncolytic for the treatment of advanced metastatic melanoma, at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL.

Clinical Trial Details

Phase II Trial Design: The Phase II trial was conducted at seven U.S. clinical centers, including the Mary Crowley Cancer Research Center, Dallas, TX; Columbia University, New York, NY; The Hubert H. Humphrey Cancer Center, Minneapolis, MN; and the University of California San Diego, San Diego, CA. Fifty patients with inoperable Stage IIIc/IV melanoma were enrolled. Patients were given OncoVEX GM-CSF injections every two weeks for up to a year. 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 with the FDA was to achieve two objective responses or stable disease >2 months.

Phase II results: Among 43 patients currently evaluable of the 50 patients enrolled, tumors injected with OncoVEX GM-CSF routinely responded, often with local complete responses or palliative benefit. With regard to systemic overall responses required for treatment success (including tumor responses at sites distant from injected tumors), six patients showed complete clinical responses; five of which are ongoing at between four and 27 months post first injection. The sixth complete response patient presented with a new lesion 15 months after initiating therapy. A further six patients achieved a partial response, five of which are ongoing 7-13 months post first injection and two of which have no disease after surgical r
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