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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
Date:9/15/2009

ession 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; repli
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