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BioVex to Report Phase I/II Clinical Trial Results for the Front Line Treatment of Head and Neck Cancer With OncoVEX GM-CSF at the 2009 American Society of Clinical Oncology Meeting

WOBURN, Mass., May 15 /PRNewswire/ -- BioVex Inc, a company developing next generation biologics for the treatment and prevention of cancer and infectious disease, announced today that the results from a Phase I/II combination study in previously untreated patients with head and neck cancer will be presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, which will take place May 29, 2009 - June 2, 2009 in Orlando, FL.

The results are to be presented in an abstract (number 6018) entitled, "Phase I/II dose escalation study of OncoVEX GM-CSF and chemoradiotherapy (CRT) in untreated stage III/IV squamous cell cancer of the head and neck (SCCHN)," at a poster session on Friday, May 29, 2009 from 2:00pm - 6:00pm EDT on Level 2, West Hall F3 of the conference. A poster discussion will take place from 5:00pm - 6:00pm EDT.

Study Rationale

Patients with head and neck cancer often present with bulky disease that is too large or too close to vital organs for surgical removal. These patients typically undergo radiation and chemotherapy treatment prior to surgery. Patients who present with tumor containing lymph nodes are particularly difficult to treat and approximately half of these patients relapse within two years.

In this 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 Stage III/IVA (N1-3) patients treated, 16 had N2 or N3 disease.

Study Results

The abstract, now available online at, reports that OncoVEX GM-CSF was well tolerated, with no significant additional side effects noted over and above those which are common with chemoradiation alone. With respect to efficacy, 94% of patients had a complete pathological response noted at surgery, with five patients achieving a complete response after only 2 or 3 viral doses. No patient has recurred locally in the neck at a median follow up of 26 months at the time of abstract submission. Three patients had distant metastatic disease. Two of these were in the low dose group. One additional low dose patient developed a new primary tumor post treatment. OncoVEX GM-CSF was detected in injected and adjacent uninjected tumors at a therapeutic dose.

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 very high percentage of patients in the mid and high dose groups that remain disease free at up to 36 months from treatment is very encouraging. As a result, OncoVEX GM-CSF clearly warrants further investigation in this setting."

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

"We are encouraged by these results which echo results in other studies using OncoVEX GM-CSF as a stand alone therapy where it remains the case that no tumor previously eradicated through OncoVEX GM-CSF therapy has been known to recur. The study reported here has demonstrated that combining OncoVEX GM-CSF with standard cancer therapies may also provide clinical benefit. Combinations involving OncoVEX GM-CSF may also allow less aggressive chemo radiation regimens to be employed whilst maintaining similar or better clinical outcomes as compared to more debilitating regimens. Following on from the ongoing pivotal Phase III study in melanoma, we plan to submit a second Phase III protocol in head and neck cancer to the FDA under the SPA procedure this summer."

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 , or an estimated 644,000 new cases annually.

Patients with locally advanced tumors are best treated with concurrent chemo radiation, with planned neck dissection indicated in certain patients. Despite aggressive treatment of locally advanced disease loco regional recurrences develop in 30% of patients, 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 works 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 generated to date, coupled with a benign side effect profile. Previous clinical trials have enrolled patients with breast cancer, melanoma, and pancreatic cancer in addition to head and neck cancer, and clinical activity has been observed in each of these cancer types. The Company recently commenced a Phase III study in metastatic melanoma following the generation of an unprecedented number 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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