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BioVex Agrees SPA With the FDA for a Pivotal Study With OncoVEX(GM-CSF) in Metastatic Melanoma and Announces Presentation of Phase II Results at ASCO

FDA agrees to first SPA for an oncolytic product

WOBURN, Mass., April 22 /PRNewswire/ -- BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase III clinical trial evaluating its lead product, OncoVEX(GM-CSF) in previously treated patients with metastatic melanoma. The agreement was made under the Special Protocol Assessment (SPA) procedure.

BioVex is currently concluding a 50-patient Phase II trial for OncoVEX(GM-CSF) as stand alone therapy in patients with unresectable Stage IIIc and Stage IV metastatic melanoma. The trial was designed to measure overall objective response, which is defined as a complete response (CR), where disease is completely eliminated, or partial response (PR), where there is a >30% reduction in disease burden. Interim results from the study demonstrated a highly encouraging rate of durable objective response with multiple patients with metastatic disease at enrollment having been declared disease free following therapy. The full study has been accepted for oral presentation at ASCO on June 1st where the results will be presented.

The Phase III study design agreed with the FDA follows directly from the study design successfully employed in Phase II. The Phase III study will also enroll previously treated patients with unresectable stage IIIc and stage IV disease using OncoVEX(GM-CSF) as monotherapy. The primary efficacy endpoint will also be response rate-based; the primary objective being to demonstrate a statistically significant increase in the rate of objective responses maintained for six months or more, in comparison to control therapy (subcutaneously administered(GM-CSF). The study is intended to enroll 360 evaluable patients randomized such that 240 patients receive OncoVEX(GM-CSF) and 120 patients receive control.

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 completing a Phase II clinical trial for melanoma and Phase I/II clinical trials for head & neck cancer and pancreatic cancer.

The Company's second program is a vaccine for genital herpes, ImmunoVEX HSV2, which provides complete protection in animal models of the disease. A Phase I study with ImmunoVEX HSV2 is scheduled to initiate later this year.

For more information visit the company's website at

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