Medarex begins Ipilimumab monotherapy trial

New Jersey, USA-based Medarex says it has initiated a registrational trial of the drug MDX-010 (ipilimumab) as a monotherapy for use by treatment-experienced metastatic melanoma patients. The product, which is a fully-human antibody which targets the human CTLA-4 protein on the surface of T cells, is being jointly developed by Medarex and US pharmaceutical major Bristol-Myers Squibb.

The trial is an open label, single-arm, registrational clinical assessment that will seek to enroll 150 patients with stage III or stage IV metastatic melanoma, who have experienced disease progression despite prior therapy. Patients will receive a 10mg/kg dose of the drug once every three weeks, for three months. Patients who have not experience diseased progression at 24 weeks will move on to a 12-weekly regimen, continuing until disease progression.

Medarex says that patient enrollment should be completed by the end of this year, and added that it intends to file a Biologics License Application in 2007.