• 2/14/2006
  • Cambridge, MA
  • press release
  • NewsWire Canada (ww.newswire.ca)

BioVex Inc, a leading developer of advanced biologics for the treatment of cancer announced today that the first patients in its phase II clinical trials of OncoVEXGMCSF in malignant melanoma and in head and neck cancer had received their initial doses of the therapeutic treatment.

The melanoma trial is a 50 patient multi-center study. The first dosing took place at the Mary Crowley Medical Research Center, Dallas, Texas. The Principal Investigator is Dr John Nemuniatis. The primary endpoint of the study is tumor response rate with secondary endpoints including time to disease progression and median survival time.

The head and neck cancer trial is a 16 patient open label study in combination with chemoradiotherapy. It is being carried out at the Royal Marsden Hospital in London (UK). The first patient in this trial has recently completed the seven week dosing regime. The Principal Investigator is Dr Kevin Harrington of the Institute of Cancer Research. The end point of the trial is to assess the safety of OncoVEXGMCSF combined with chemoradiotherapy, and the potential of OncoVEX as neoadjuvant therapy in the treatment of head and neck cancer.

Preliminary results from both trials will be available in late 2006.

OncoVEX GMCSF is the first in a new class of oncolytic virus that selectively kills tumor cells. In addition it induces tumor cells to secrete GMCSF, to enhance tumor destruction. OncoVEX GMCSF has completed a Phase I/II study in several solid tumors including breast cancer, head and neck cancer, gastro-intestinal cancer and melanoma. Results from the administration of OncoVEX GMCSF in either single or multiple doses have shown the product to be well tolerated. Substantial biological effects, including tumor necrosis, were also observed. BioVex is planning additional clinical studies in pancreatic, colorectal and lung cancers that are expected to begin during 2006.

“The opening of these Phase II clinical trials of OncoVEXGMCSF in malignant melanoma, which is a cancer with one of the fastest growing incident rates world wide, and in first line therapy for head and neck cancer, demonstrate BioVex’s commitment to bringing novel biological treatments for cancer forward into the clinic,” said Dr. Gareth Beynon, CEO of BioVex. “The initiation of the phase II trials marks our continuing growth and development since relocating to the US in 2005

Dr Nemuniatis commented, “Melanoma is a problem of increasing seriousness and BioVex’s unique strategy using a dual approach of a potent oncolytic agent, coupled with the local release of a powerful cytokine may offer an important advance in our understanding of treatment options.”

Dr Harrington commented, “I am very pleased to be participating in this study using the potentially powerful added effect that OncoVEXGMCSF may bring to the treatment of head and neck cancer.”

About head and neck cancer

Head and neck cancer is the generic term used for a group of malignant tumors that affect areas such as the face, mouth, jaws, sinuses, throat, larynx, salivary glands, thyroid gland and neck. Treatment is often complex and requires the cooperation of a number of medical, paramedical and nursing specialists. Although head and neck cancer is relatively uncommon in the UK (around 8000 new cases per year), it is the sixth most common cancer worldwide (British Association of Head and Neck Oncologists). In the USA there are currently some 214,000 affected patients with approximately 40,000 new cases per annum. The US five year survival rate for invasive oral cavity and pharyngeal cancer has remained unchanged at 53% since 1976.