BioVex Limited, a private biotech company developing therapeutics for cancer and chronic infectious disease, reported that the UK's Medicines Control Agency ("MCA") has approved the Company's application to commence a clinical trial of OncoVEX GM-CSF.

The Phase I trial will be undertaken at the Hammersmith Hospital in London and led by Professor Charles Coombes (Professor of Oncology, Imperial College School of Medicine). The safety and biological activity of OncoVEX GM-CSF will be evaluated in a number of solid tumours in an 18 patient study. These tumours include melanoma, breast cancer, gastro-intestinal cancer and head and neck cancer.

OncoVEX products are versions of herpes simplex virus (HSV I) which have been engineered such that they replicate selectively in tumour cells, destroying the tumour in the process.

In addition to the anti-tumour effect provided by the oncolytic virus itself, OncoVEX GM-CSF carries the gene encoding human GM-CSF. GM-CSF is a potent immune stimulator and its presence is designed to further stimulate the body's immune response to tumour cells.

First generation products based on viruses that selectively replicate in and destroy tumour cells without affecting healthy tissue have demonstrated proof of principle in man and have been shown to be well tolerated. BioVex has constructed a series of proprietary "second generation" OncoVEX viruses which are not only more lytic than first generation products but are also designed to stimulate the immune system to destroy metastatic deposits. This has been engineered by the deletion of HSV "immune suppressor genes" and, in the case of its lead product, the insertion of an immune stimulating cytokine gene

Dr Gareth Beynon, chief executive officer of BioVex said, "OncoVEX GM-CSF is the first product in the BioVex portfolio to progress into the clinic. The approval of the Company's first application to the MCA is therefore a major milestone in the Company's development. OncoVEX GM-CSF is designed to enhance the clinical efficacy of replicating virus therapy for the treatment of solid tumours and to stimulate the immune system to destroy metastatic deposits."