Elesclomol being tested for treatment of metastatic melanoma

Lexington, Mass. - Synta Pharmaceuticals has launched a phase 3 trial of elesclomol in treating metastatic melanoma, Bioworld.com reports.

Synta recently signed a billion-dollar deal with GlaxoSmithKline for the drug, formerly STA-4783.

The trial will enroll about 630 stage IV metastatic melanoma patients who have not previously received chemotherapy. They will be randomized to receive elesclomol plus paclitaxel or paclitaxel alone until their disease progresses.

There will be two evaluation stages, the first an interim analysis designed to assess safety and nonfutility, which likely will occur in mid-2008, and the second to occur sometime around the completion of enrollment, which is targeted for late 2008.

If the late 2008 primary endpoint analysis is positive, Synta officials say, the company plans to move forward with a new drug-application filing by mid-2009. The officials add that the company may file for approval before finishing the trial because not all 630 patients are needed to establish progression-free survival.

They say that though only 300 to 400 patients are needed for the trial, more patients are being enrolled in order to acquire additional data on a secondary endpoint of overall survival. Other secondary endpoints include response rate, clinical benefit rate and duration of response.