BioVex announced preliminary Phase I results from the clinical trial of its lead oncology product candidate, OncoVEX (GM-CSF) in patients with breast cancer and melanoma.

OncoVEX (GM-CSF) is the first oncolytic virus (that selectively replicates in and kills tumour cells) containing an immune stimulating factor to enter clinical development. The product is designed to induce both local tumour destruction and a systemic anti-tumour immune response to treat secondary (metastatic tumour) deposits.

The primary aim of the clinical trial is to determine safety. In addition, indications of biological activity are determined through the assessment of virus replication, the expression of GM-CSF in the tumour, histological examination of tumour biopsies for evidence of cell necrosis and immune cell infiltration, and gross observation of tumours for signs of tumour destruction.

The study design includes a single dose escalation phase at doses of 10 to the power of 6, 10 to the power of 7 and 10 to the power of 8 virus particles/ml to be given to groups of four patients at each dose to be followed by three repeated injections at the optimal dose in a further group of six patients.