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 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% 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 end point of the trial is to assess the safety of OncoVex GMCSF 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 an oncolytic virus that selectively kills tumor cells. In addition it induces tumor cells to secrete GMCSF, to enhance tumor destruction. The drug 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.
Commenting on the melanoma trial, principle investigator Dr Nemuniatis said: “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.”