BioVex to Report Phase II Clinical Trial Results of OncoVEX GM-CSF in Metastatic Melanoma at the 2008 American Society of Clinical Oncolo...(c objective overall responses; three com...),Health

Date:5/16/2008

c objective overall responses; three complete responses (CR), three partial responses (PR) and two mixed responses (greater than or equal to PR of existing disease and greater than or equal to PR of lesions which became measurable after initiation of therapy) were reported. Two further patients had post treatment objective responses and four patients had durable stable disease. All objective responses were ongoing at between four and 23 months following the patient's first dose of OncoVEX GM-CSF. Side effects were reported to be largely limited to mild flu-like symptoms, as expected from the Phase I study.

Abstract Conclusion: An impressive rate and durability of response had been observed in this interim dataset as compared to the other limited treatment options available to patients with advanced melanoma.

BioVex President and CEO Philip Astley-Sparke commented:

"Based on the data described above, the Company recently reached agreement with the FDA for a pivotal Phase III study under the Special Protocol Assessment (SPA) procedure, with a response rate-based primary endpoint. We look forward to Dr Senzer's presentation on an up-to-date expanded data set at ASCO on June 1st."

About Metastatic Melanoma

According to the American Cancer Society, more than 8,000 people died in the U.S. of melanoma in 2007. 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 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 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
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SOURCE BioVex Inc Copyright©2008 PR Newswire. All rights reserved

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