The herpes simplex virus had been modified so it multiplies inside cancer cells but not healthy cells. It bursts and kills tumour cells and, by expressing a human protein, it also helps stimulate patients’ immune systems.
Principal Investigator Dr Kevin Harrington, from The Institute of Cancer Research (ICR) and The Royal Marsden Hospital in London, said: “Patients with head and neck cancer often present with disease that is too advanced for surgery. These patients are typically treated with radiation and chemotherapy, in some cases followed by surgery. Phase I/II data indicates OncoVEX has the potential to decrease the relapse rate in this group of patients and could be safely used in combination with other cancer treatments. We look forward to the results of this large-scale study.”
The study will enrol 528 patients in the US and UK who have not received any previous treatments for their locally advanced disease.
All patients will be treated with chemotherapy and radiotherapy, while the test group will also receive injections of OncoVEX directly into cancer-affected lymph nodes. The trial aims to determine whether the OncoVEX treatment group has a better chance of survival – including lower rates of relapse – after two years.
The ICR and The Royal Marsden led the small Phase I/II trial testing the safety of the drug in 17 head and neck cancer patients. Side-effects, which were published in July, were found to be generally mild to moderate, and most – except fever and fatigue – were thought to be due to the chemotherapy or radiotherapy. After an average follow-up time of 29 months, 82.4 per cent of patients had not succumbed to the disease; this compares to typical relapse rates of between 35 to 55 per cent for patients given standard chemoradiation.
Around 650,000 people are diagnosed with squamous cell cancer of the head and neck each year worldwide, and around 350,000 die from the disease annually.
BioVEX has also started a Phase III trial of OncoVEX in melanoma patients, which is approaching full accrual.
Dr Robert Coffin, Founder and Chief Technology Officer of BioVex Inc, said: “We believe that OncoVEX has the potential to provide a broadly active new treatment approach that will substantially improve patient outcomes in a variety of hard-to-treat tumour types as both a monotherapy and in combination with other therapies. The start of a second pivotal Phase III study is part of a broad planned development programme for OncoVEX beyond our lead indication of metastatic melanoma.”
Notes to editors:
Further details on this study can be found at www.clinicaltrials.gov
BioVex is a privately held biotechnology company based in Woburn, Massachusetts, US, where it also has an operational commercial scale manufacturing facility. The company is developing a new class of potent biologics for the treatment of cancer and prevention of infectious disease. In addition to OncoVEX, the company has a second development program, ImmunoVEX, a vaccine for genital herpes that provided complete protection in animal models of the disease. The vaccine is currently undergoing clinical testing in the United Kingdom. BioVex closed a $70m funding round late last year representing the second largest venture capital raise in the biotech sector in 2009.