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BioVex Reports Positive Phase II Clinical Trial Results of OncoVEX GM-CSF in Metastatic Melanoma at the 2008 American Society of Clinical Oncology Meeting
Date:6/1/2008

esection of residual tumors.

The current rate of objective response stands at 28%. Other patients have shown clinical benefit including prolonged periods of stable disease as well as post treatment responses after being withdrawn from the study for initial progression. Seven patients remain on study with stable disease 3 to 10 months post initiation of therapy. Side effects were mild and mainly limited to transient flu-like symptoms.

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

"Patients with advanced melanoma have few current treatment options that produce a lasting clinical response. OncoVEX GM-CSF has shown it can engender durable objective responses in a substantial proportion of patients. This efficacy profile combined with a lack of any serious side effects makes this product candidate one of the most promising later stage experimental cancer therapies currently in clinical development."

FDA approved pivotal Phase III study design

BioVex recently announced that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase III clinical trial evaluating OncoVEX GM-CSF in previously treated patients with metastatic melanoma. The agreement was made under the Special Protocol Assessment (SPA) procedure. The Phase III study design agreed upon with the FDA follows directly from the study design successfully employed in Phase II, incorporating a response rate based primary endpoint -- the rate of objective responses maintained for six months or more. The study is expected to commence in the first quarter of 2009, with a potential projected biologics licensing application (BLA) filing in late 2010.

BioVex President and CEO Philip Astley-Sparke commented:

"OncoVEX GM-CSF is poised to become the first product in its class to enter into a pivotal, Phase III study. I am extremely proud of the commitment that all our management
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SOURCE BioVex Inc
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1. BioVex to Report Phase II Clinical Trial Results of OncoVEX GM-CSF in Metastatic Melanoma at the 2008 American Society of Clinical Oncology Meeting
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