BioVex seeks FDA OK for melanoma trial

OncoVex (GM-CSF), BioVex’ lead product candidate for the treatment of solid tumors, is an oncolytic virus that selectively kills tumor cells. It also induces tumor cells to secrete GM-CSF, a powerful immune stimulator, potentially enhancing the destruction of both injected and metastatic tumor deposits.

A phase I/II study of OncoVex (GM-CSF) in several solid tumors including breast cancer, head and neck cancer, gastro-intestinal cancer and melanoma has been completed. Results from the administration of OncoVex (GM-CSF), in either single or multiple doses, have shown the product to be well tolerated and substantial biological effects, including tumor necrosis, have been observed.

“Submitting an investigational new drug application (IND) for OncoVex (GM-CSF) is a significant milestone for BioVex” said Gareth Beynon, the company’s CEO. “We believe the combination of oncolytic activity with the effects of GM-CSF on the immune system could be potentially useful in treating a number of solid tumors. Pending clearance by the FDA we look forward to progressing OncoVex (GM-CSF) into a phase II clinical study in melanoma this summer.”