BioVex Inc, a company developing next generation biologics for the treatment and prevention of cancer and infectious disease, announced  that a phase III pivotal study with OncoVexgm-CSF for the first line treatment of patients with locally advanced Squamous Cell Carcinoma of the Head & Neck (SCCHN) has commenced. The study will be conducted across sites in the US and the UK.

Dr Kevin Harrington, Principal Investigator from The Institute of Cancer Research 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 1/2 data indicates OncoVexgm-CSF 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.”

Dr Robert Coffin, Founder and Chief Technology Officer of BioVex Inc said: “We believe that OncoVexgm-CSF 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 3 study is part of a broad planned development program for OncoVexgm-CSF beyond our lead indication of metastatic melanoma. Our OPTiM (OncoVex Pivotal Trial in Melanoma) study is approaching full accrual.”

The phase III study design agreed with the FDA under the SPA process is based on the design of our previous study in SCCHN. The Phase III study will enroll 528 previously untreated patients with locally advanced disease. The primary objective of the study will be to demonstrate a statistically significant increase in two year event free survival (relapse, progression, or death) for patients treated with chemoradiation together with OncoVexgm-CSF compared to patients treated with chemoradiation alone.

In a phase I/II study in SCCHN, OncoVexgm-CSF was administered by direct injection, at three dose levels, into tumour containing lymph nodes in combination with standard first line chemo radiotherapy every three weeks for four cycles prior to surgical resection. Of the 17 patients enrolled, 16 had Stage IV N2 or N3 disease. OncoVexgm-CSF was shown to be well tolerated with no significant side effects in addition to those associated with chemo-radiation.

With respect to efficacy, 93% of patients had a complete pathological response at surgery, with five patients achieving a complete response after only 2 or 3 OncoVexgm-CSF doses. No patient had a loco-regional recurrence in the neck at a median follow up of 30 months with a disease specific survival rate of 82% at that time.

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).

The treatment of head and neck cancer requires a multidisciplinary approach with an experienced team that includes a head and neck surgeon, a radiation oncologist, and a medical oncologist. Early-stage head and neck cancers (especially laryngeal and oral cavity) have high cure rates, but over 60% of head and neck cancer patients present with advanced loco-regional disease. Cure rates decrease in locally advanced cases, whose probability of cure is inversely related to tumour size and even more so to the extent of regional node involvement.

Patients with locally advanced tumours are routinely treated with concurrent chemo-radiation, with planned neck dissection indicated in certain patients. Such combined modality therapy may be frequently associated with debility, and numerous physical and psychological symptoms including pain, dysphagia (swallowing difficulty), weight loss, disfigurement, depression, and xerostomia (dry mouth). Despite aggressive treatment of locally advanced disease, only 50% of patients remain disease free two years after standard curative treatment.

OncoVexgm-CSF is a first in class oncolytic vaccine which replicates selectively in tumours destroying cancer cells whist leaving surrounding healthy cells unharmed. OncoVexgm-CSF is also intended to induce a powerful immune response that kills cancer cells throughout the body. Both modes of action have been validated in the clinic, where multiple patients with metastatic disease progressing at enrollment have become free of disease.

BioVex believes OncoVexgm-CSF has the potential to become a leading standard of care in the treatment of many solid tumours based on the strength of clinical data so far generated coupled with the relatively benign side effect profile noted to date. Previous clinical trials have enrolled patients with breast cancer, melanoma, head and neck cancer and pancreatic cancer, with indications of clinical activity being observed in each. The Company is currently conducting a Phase 3 study in metastatic melanoma (the OPTiM study) following achieving an unprecedented proportion of durable complete remissions in a Phase 2 study using OncoVexgm-CSF as a stand alone therapy.

BioVex is a privately held biotechnology company based in Woburn, Massachusetts 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.