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BioVex To Announce Updated Survival Data From a Phase II Clinical Study of OncoVEX GM-CSF in Metastatic Melanoma at The 2009 American Society of Clinical Oncology Meeting
Date:5/15/2009

tients, 58% for all Stage IV patients and 48% for Stage IV M1c patients. The 1-year survival of the patients who achieved PR, CR or surgical CR (n=15) was 93% compared to 48% for those with stable or progressive disease.

Commenting on these results, Dr. Neil N. Senzer of The Mary Crowley Cancer Research Center in Dallas, TX, the lead author for the presentation, said:

"Compared to any historical benchmarks for patients with Stage IIIc and Stage IV melanoma, this survival data, especially when coupled with a low toxicity profile, is provocative. Additionally, of the responses previously reported the vast majority have been maintained for up to more than three years from enrollment. I look forward to the results of the subsequent Phase III study which has recently initiated."

OPTiM Phase III Trial

The trial is a multi-national, open label, randomized Phase 3 study to assess the efficacy and safety of treatment with OncoVEX GM-CSF as compared to sub cutaneously administered GM-CSF in patients with unresectable stage III (b-c) and Stage IV (M1a-c) disease. The primary endpoint is the rate of durable (maintained for six months) objective response. 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 the OncoVEX GM-CSF arm and 120 to the control arm). The study design was agreed with the FDA under the Special Protocol Assessment ("SPA") process. The SPA process provides for a designation from the FDA that the trial's design, clinical endpoints and statistical analysis can be used for regulatory approval.

About Metastatic Melanoma

According to the American Cancer Society, more than 8,000 people died in the U.S. of me
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SOURCE BioVex Inc
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