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BioVex Agrees SPA With the FDA for a Pivotal Phase III Study With OncoVEX (GM-CSF) in Head and Neck Cancer
Date:9/15/2009

cating and spreading within solid tumors (whilst leaving healthy cells unaffected), causing the death of cancer cells; and through 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 metastatic disease progressing at enrollment have been declared disease free. BioVex believes OncoVEX (GM-CSF) has the potential to become a leading standard of care in the treatment of many solid tumors based on the strength of clinical data so far generated coupled with the relatively benign side effect profile noted to date. Previous clinical trials have enrolled patients with breast cancer, melanoma, and pancreatic cancer in addition to head and neck cancer, with indications of clinical activity being observed in each. The Company recently commenced a Phase III study in metastatic melanoma following the achievement of an unprecedented proportion of durable complete remissions in a Phase II study using OncoVEX (GM-CSF) as stand alone therapy. An overview of the Phase II melanoma results is available on our website.

The Company's second program is a vaccine for genital herpes, ImmunoVEX (HSV2), which provides complete protection in animal models of the disease. The vaccine has been authorized to commence clinical testing in the UK.

For further information, please go to www.biovex.com.


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