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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

WOBURN, Mass., Sept. 15 /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), for the first-line treatment of patients with squamous cell cancer of the head and neck.

The study is the second the Company has agreed with the FDA under the Special Protocol Assessment (SPA) procedure and highlights the broad potential utility of BioVex's first-in-class cancer destroying virus technology. The first SPA was in melanoma under which BioVex is currently conducting a pivotal Phase III trial.

Patients with head and neck cancer often present with locally advanced, bulky disease that is too large, or too close, to vital organs to remove surgically. These patients typically undergo combination radiation and chemotherapy treatment, in some cases with additional surgery. Patients who present with tumor-containing lymph nodes are particularly difficult to treat and approximately half of these patients relapse within two years.

Philip Astley-Sparke, President & CEO, for BioVex said:

"The announcement of our second SPA governing a Phase III study demonstrates the breadth of the commercial opportunity with OncoVEX (GM-CSF). In addition to treating metastatic disease as is the intention in our ongoing Phase 3 study in melanoma, following multiple systemic responses in Phase II, OncoVEX (GM-CSF) also has considerable potential utility in treating discrete solid tumor masses across multiple indications including those that are poorly served by radiation. As with tumors like head and neck cancer where loco-regional progression is the primary cause of treatment failure, treating discrete tumor masses is a major unmet need in a wide range of settings. It is our belief that, as a result, this technology has the potential to provide a broadly active new modality to substantially improve patient outcomes in a variety of hard-to-treat tumor types. "

Phase III Study Design

The Phase III study design agreed with the FDA follows directly from the design of the previous study. The Phase III study will also enroll previously untreated patients with locally advanced disease. The primary objective of the study will be to demonstrate a statistically significant increase in 2-year event free survival (i.e. relapse, progression, or death) for patients treated with chemoradiation together with OncoVEX (GM-CSF) as compared to patients treated with chemoradiation alone. The study will involve approximately 400 patients with approximately 200 in each arm.

Phase I/II Study Design and Results

In a Phase I/II study, OncoVEX (GM-CSF) was administered by direct injection, at three dose levels, into tumor containing lymph nodes in combination with standard first line chemo radiotherapy every three weeks for four cycles. All patients then went for surgery. Of the 17 patients enrolled, 16 had Stage IV N2 or N3 disease. OncoVEX (GM-CSF) was shown to be well tolerated with no significant side effects in addition to those associated with chemoradiation. With respect to efficacy, 93% of patients had a complete pathological response at surgery, with five patients achieving a complete response after only 2 or 3 virus doses. No patient to date has had a loco-regional recurrence in the neck at a median follow up of 30 months, and the disease specific survival rate is currently 82%.

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

"Loco-regional control is extremely important in head and neck cancer where loco regional progression is responsible for the majority of deaths. The two year loco-regional failure rate following front line treatment is around 30% with a further 20% of patients progressing at a distant site. The long-term loco-regional control rate of 100% combined with the high percentage of patients that remain disease free at up to 40 months from treatment is very encouraging and provides confidence that OncoVEX (GM-CSF) will significantly reduce relapse rates as compared to standard therapy alone in the pivotal study recently agreed with the FDA."

About Head and Neck Cancer

Head and neck cancer accounts for 47,000 new cases (3% of all new cancer cases and 2% of all cancer deaths) in the United States annually; it is the fifth most common malignancy worldwide (an estimated 644,000 new cases annually).

Patients with locally advanced tumors are best treated with concurrent chemoradiation, with planned neck dissection indicated in certain patients. Despite aggressive treatment of locally advanced disease loco-regional recurrences develop in 30% of patients and distant metastases in 20%. Aggressive combined modality therapy may be frequently associated with debility, and numerous physical and psychological symptoms including pain, dysphagia, weight loss, disfigurement, depression, and xerostomia (dry mouth). As a result, new and improved, and less toxic therapies for head and neck cancer are urgently required.

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) designed to work by; replicating 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.

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