Phase I/II clinical study data of OncoVEXGM-CSF for head and neck cancer published in Clinical Cancer Research

Aug 2 2010

BioVex Inc, a company developing new generation biologics for the treatment of cancer and prevention of infectious disease, announces that the data from its completed Phase I/II clinical study of OncoVEX^GM-CSF for the first line treatment of head and neck cancer is being published today in Clinical Cancer Research, an ASCO publication.

The previously announced top line results report a high complete pathological response rate and a low relapse rate in combination with cisplatin and radiation, combined with a relatively benign side effect profile. Following from this data, a Phase III study, also in patients with previously untreated squamous cell carcinoma of the head and neck, will begin later this year under an SPA (Special Protocol Assessment) from the FDA, as previously announced.

In the study published today, OncoVEX^GM-CSF was injected into 17 patients' cancer-affected lymph nodes in up to four doses, and the patients were also given radiotherapy and chemotherapy. Head and neck tumour shrinkage could be seen on scans for 14 patients (82.3%), while 93 per cent of patients had no trace of residual cancer in their lymph nodes when subsequently surgically removed. After an average follow-up time of 29 months (19 to 40 months), 82.4 per cent of patients remained alive. Only two of 13 patients given the top virus treatment dose relapsed, and no patient had recurrent loco-regional disease.

Side-effects were generally mild to moderate, and most - except fever and fatigue - were thought to be due to the chemotherapy or radiotherapy. OncoVEX^GM-CSF has previously shown promising results when administered on its own in patients with other cancer types, including a Phase II trial in metastatic melanoma patients where a Phase III trial is currently underway.

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.

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

"Up to half of patients given the current standard treatment of chemotherapy combined with radiotherapy typically relapse within two years, following which the prognosis is grim, so these results compare very favorably. This, combined with the very high complete pathological response rate indicates that OncoVEX^GM-CSF may provide significant additional clinical benefit to chemotherapy and radiotherapy alone, hence our decision to move directly to a pivotal Phase III trial.

In addition to head and neck cancer, and melanoma where a pivotal Phase III trial is currently underway, we also believe that OncoVEX^GM-CSF has significant potential to treat a wide variety of other tumor types either alone or in combination with other therapies, for which the planning of additional clinical trials is underway."

SOURCE BioVex Inc