BioVex initiates Phase III melanoma study

The study has commenced recruiting patients in the US with sites in the UK, Germany and Australia due to open later in 2009.

The OPTiM trial is a multi-national, open-label, randomized Phase III study designed to assess the efficacy and safety of treatment with OncoVEX (GM-CSF) as compared to subcutaneously administered GM-CSF in patients with unresectable stage III (b-c) and stage IV (M1a-c) disease. Patients will have received at least one prior therapy for active disease which includes any type of therapy including investigational drugs.

A total of 360 patients will be enrolled (240 to the OncoVEX (GM-CSF) arm and 120 to the control arm). The study design was agreed with the FDA under the special protocol assessment process (SPA). The SPA process provides for a designation from the FDA that the trial’s design, clinical endpoints and statistical analysis can be used for regulatory approval.

Robert Coffin, founder and chief technology officer of BioVex, said: “The treatment options for patients with recurrent or metastatic melanoma are currently very limited, with no therapy being approved or recognized to be effective in the second line setting and beyond. Currently, there are also very few late stage or pivotal clinical studies available for patients who have failed first line therapy.

“The initiation of this study, following the highly encouraging data generated in Phase II, is therefore a significant milestone on the path towards meeting this major unmet need, and towards the approval of OncoVEX (GM-CSF) in this first indication.”