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BioVex Announces Publication of Phase 2 Melanoma Results With OncoVEX (GM-CSF) in the Journal of Clinical Oncology
Date:11/2/2009

e and death," said Dr. Howard Kaufman of the Rush University Medical Center in Chicago, principal investigator of an ongoing Phase 3 OPTiM(TM) study with OncoVEX (GM-CSF) in Stage III and Stage IV melanoma. "The ability to simply administer the vaccine in the office setting represents a significant improvement in quality of life for patients with melanoma."

"We believe that OncoVEX (GM-CSF) is the most advanced clinical development program globally using viruses for cancer therapy, and we are committed to the further evaluation of OncoVEX (GM-CSF) for the treatment of metastatic melanoma and other solid tumors," said Robert Coffin, PhD, Founder & Chief Technology Officer of BioVex.

About the Phase 2 OncoVEX (GM-CSF) Study in Melanoma

The Phase 2 trial enrolled 50 patients with Stage IIIc (10 patients) and Stage IV melanoma (40 patients) who were treated with OncoVEX (GM-CSF) as a stand-alone therapy. 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 more than 30% reduction in disease burden. The vast majority of patients who entered the study had progressive disease after having failed conventional and experimental prior therapies. Fourteen objective systemic responses (28% objective response rate) were ultimately achieved, including on an extension protocol to which four patients were transferred having completed the main study, including 10 complete responses. Responses have been maintained for up to nearly four years so far. Responses were observed in patients with all stages of disease, including the complete resolution of un-injected visceral deposits.

About the OPTiM(TM) Phase 3 Study

BioVex has now begun a multi-national, randomized Phase 3 OPTiM Study to assess the efficacy and safety of treatment with OncoVEX (GM-CSF) as compared to subcut
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SOURCE BioVex Inc
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