FDA Approves Kosan’s Tanespimycin Trial Design

Kosan Biosciences announced that it has reached an agreement with the FDA on the design of its Tanespimycin in Myeloma Evaluation-1 (TIME-1) clinical trial, a Phase III study of its heat shock protein 90 inhibitor tanespimycin as a treatment for patients with multiple myeloma.

The open-label, randomized, multicenter TIME-1 trial will take place in the U.S. and Europe and enroll more than 450 patients who relapsed following a single course of treatment. The trial will compare patients treated with bortezomib plus tanespimycin versus patients treated with bortezomib alone, Kosan said.

TIME-1 is designed with a primary endpoint of progression-free survival and will include an interim analysis of safety and efficacy, the company added.