BioVex Commences OncoVEX (GM-CSF) Phase 3 Trial in Metastati... (ic therapies are not generally effective...)

BioVex Commences OncoVEX (GM-CSF) Phase 3 Trial in Metastatic Melanoma

Date:4/14/2009

ic therapies are not generally effective in terms of generating durable responses or in impacting survival. As a result, many patients presenting with metastatic disease are directly enrolled into a clinical trial. The vast majority of experimental therapies have failed to show more than a single digit response rate.

About BioVex

BioVex is a privately held biotechnology company based in Woburn, MA where it also has an operational launch grade manufacturing facility. 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 a first-in-class oncolytic, or cancer destroying virus technology. OncoVEX (GM-CSF) works by: replicating and spreading within solid tumors, causing the death of cancer cells; while 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 generated to date, coupled with a benign side effect profile. Previous clinical trials have enrolled patients with breast cancer, head and neck cancer, and pancreatic cancer in addition to melanoma, and clinical activity has been observed in each case. The Company plans to submit a second Phase 3 protocol in head and neck cancer to the FDA under the SPA procedure in the middle of the year.

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.

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BioVex Commences OncoVEX (GM-CSF) Phase 3 Trial in Metastati...(ic therapies are not generally effective...)