BioVex Agrees SPA With the FDA for a Pivotal Study With OncoVEX(GM-CSF) in Metastatic Melanoma and Announces Presentation of Phase II Resul...(l. The pivotal study is expected to c...),Health

The pivotal study is expected to commence in the first quarter of 2009, with a potential projected BLA filing in late 2010. BioVex is currently commissioning its GMP manufacturing facility in Woburn, Massachusetts, which is intended to provide product for Phase III studies and launch.

Dr Robert Coffin, Chief Technology Officer for BioVex, said:

"This agreement with the FDA for the pivotal Phase III study design for OncoVEX(GM-CSF) in melanoma, which uses a very similar design as successfully employed in Phase II, is a significant event for BioVex. We believe the Phase II study results relating to durable objective response provide a sound basis on which to proceed with confidence to Phase III where the primary objective is to demonstrate a statistically significant increase in durable objective responses as compared to control therapy. We look forward to the presentation of the Phase II results at ASCO, and thereafter to the initiation of the pivotal study."

About BioVex

BioVex is a privately held biotechnology Company based in Woburn, MA. The Company is developing a new class of potent biologics for the treatment of cancer and prevention of infectious disease.

The Company's lead cancer technology platform, OncoVEX(GM-CSF), is an unpartnered, first-in-class oncolytic, or cancer destroying virus technology. OncoVEX(GM-CSF) works by: 1) replicating and spreading within solid tumors, causing the death of cancer cells; while 2) stimulating the immune system to destroy 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. Based on the strength of the clinical data generated to date, coupled with a benign side effect profile, BioVex believes OncoVEX(GM-CSF) has the potential to become a leading standard of care in the treatment of many solid tumors.

OncoVEX(GM-CSF) is currently complet
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