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BioVex Announces Regulatory Clearance to Commence a Clinical Study With ImmunoVEX HSV2; A Vaccine Candidate for Genital Herpes

WOBURN, Mass., Aug. 20 /PRNewswire/ -- BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, today announced the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted BioVex's Clinical Trial Application to conduct a Phase I clinical study testing the safety and immunogenicity of its lead infectious disease candidate for genital herpes, ImmunoVEX HSV2.

ImmunoVEX HSV2 is a novel live-attenuated vaccine which has been rationally designed to remove the genes that allow herpes virus to avoid the immune system. This should allow the immune system to recognize and mount a powerful immune response against the causative agent of genital herpes. In preclinical studies, ImmunoVEX HSV2 completely prevented all symptoms of genital herpes and triggered a powerful immune response, suggesting that ImmunoVEX HSV2 may be more potent than other HSV-2 vaccines for which data has been published.

BioVex's Founder and Chief Technology Officer, Dr. Robert Coffin, commented:

"Genital herpes is a significant and growing public health issue. All previous attempts to develop either a prophylactic or therapeutic vaccine have either failed or have shown efficacy in only a very limited proportion of the population. We believe that this vaccine, based on a new understanding of HSV biology, has the potential to substantially advance the field. Accordingly, today's news is a significant milestone towards realizing this potential."

About Genital Herpes

At least 45 million people over the age of 12 in the United States have been infected with HSV-2, the cause of genital herpes, according to the Centers for Disease Control and Prevention. There is currently no cure for genital herpes and the standard treatment protocol includes daily suppressive therapy and antiviral medications.

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, OncoVEXGM-CSF is a first-in-class oncolytic, or cancer destroying virus technology. OncoVEXGM-CSF works by: replicating and spreading within solid tumors, causing the death of cancer cells; while 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. BioVex believes OncoVEXGM-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 generated to date, coupled with a benign side effect profile.

BioVex is currently completing a Phase II clinical trial of OncoVEXGM-CSF for melanoma and Phase I/II clinical trials for head & neck cancer and pancreatic cancer. Earlier this year, the Company announced that the FDA approved the design of a single, pivotal Phase III clinical trial evaluating OncoVEXGM-CSF in previously treated patients with metastatic melanoma under the Special Protocol Assessment (SPA) procedure and plans to make a second SPA submission for head & neck cancer later in the year. BioVex intends to begin its Phase III trial for OncoVEXGM-CSF in melanoma in the first quarter of 2009.

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