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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

aneously administered GM-CSF in patients with unresectable Stage III (b-c) and Stage IV (M1a-c) melanoma. The primary endpoint is the rate of durable (maintained for six months) objective response. A total of 360 patients will be enrolled (240 to the OncoVEX arm and 120 to the control arm). The study design was agreed with the Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process, which provides agreement with the FDA that the trial's design, clinical endpoints and statistical analysis, if the study is successful, are appropriate to be used as the basis for regulatory approval.

About Metastatic Melanoma

According to the American Cancer Society, more than 8,000 people died in the U.S. of melanoma in 2008. Prevalence of Stage III and Stage IV disease is 120,000 and median survival for Stage IV disease is six months.

Treatment of melanoma depends on the stage of the disease with surgical resection being effective in the early stages of the disease. However, survival rates for the later Stage III and Stage IV patients are poor, reflecting the lack of effective drugs for recurrent or metastatic disease. Current systemic therapies are not generally effective in terms of generating durable responses or in impacting survival. As a result, many patients presenting with metastatic disease are directly enrolled into a clinical trial. The vast majority of experimental therapies to date have failed to show more than a single digit durable response rate.

About OncoVEX

The Company's lead cancer treatment, OncoVEX (GM-CSF) is a first-in-class oncolytic, or cancer destroying virus, that works by replicating and spreading within solid tumors (leaving healthy cells unaffected), thereby causing cancer cell death and stimulating the immune system to destroy un-injected metastatic deposits. Both modes of action have been clearly validated in the clinic, where multiple patients with metas
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SOURCE BioVex Inc
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