BioVex Commences OncoVEX (GM-CSF) Phase 3 Trial in Metastati... (the OncoVEX (GM-CSF) arm and 120 to the ...)

BioVex Commences OncoVEX (GM-CSF) Phase 3 Trial in Metastatic Melanoma

Date:4/14/2009

the OncoVEX (GM-CSF) arm and 120 to the control arm). The study design was agreed with the FDA under the Special Protocol Assessment process ("SPA"). 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 OncoVEX (GM-CSF) Phase II Clinical Trial

BioVex recently concluded a 50-patient Phase II trial for OncoVEX (GM-CSF) as a stand-alone therapy in patients with Stage IIIc and Stage IV melanoma. The trial was designed to measure overall objective response, which is defined as a complete response (CR), where disease is completely eliminated, or partial response (PR), where there is a >50% reduction in disease burden. 74% of patients who entered the study were progressing after having failed prior therapy. 13 objective systemic responses (26% objective response rate) were achieved including eight CRs, seven of which remain free of disease. 12 responses have so far continued for more than 6 months (range 6-29+ months). Responses were observed in patients with all stages of disease, including the complete resolution of un-injected visceral deposits.

About Metastatic Melanoma

According to the National Cancer Institute, more than 8,000 people in the U.S. died of melanoma in 2008. At least 53,000 people in the U.S. are diagnosed with melanoma annually and the incidence of the disease has more than doubled in the past 30 years. The median survival for patients diagnosed with late-stage metastatic disease, or Stage IV disease, is six to nine months.

Treatment of melanoma depends on the stage of the disease with surgical resection being effective in less severe non metastatic forms of the disease. However, survival rates for later Stage III and IV patients are poor, reflecting the lack of any efficacious drugs for metastatic disease. Current system
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BioVex Commences OncoVEX (GM-CSF) Phase 3 Trial in Metastati...(the OncoVEX (GM-CSF) arm and 120 to the ...)