BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, announced the US Food and Drug Administration (FDA) has approved the design of a single, pivotal, phase-III clinical trial evaluating its lead product, OncoVEXGM-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, with in some cases additional surgery. Patients who present with tumour 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 OncoVEXGM-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, OncoVEXGM-CSF also has considerable potential utility in treating discrete solid tumour masses across multiple indications including those that are poorly served by radiation. In addition to tumours like head and neck cancer where loco-regional progression is the primary cause of treatment failure, treating discrete tumour masses is a major unmet need in 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 tumour types."

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 per cent with a further 20 per cent of patients progressing at a distant site. The long term loco-regional control rate of cent per cent 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 OncoVEXGM-CSF will significantly reduce relapse rates as compared to standard therapy alone in the pivotal study recently agreed with the FDA."

BioVex is a privately held biotechnology company based in Woburn, MA where it also has an operational launch grade manufacturing facility.