Kosan's pivotal Ph III tanespimycin trial starts recruiting

The USA's Kosan Biosciences' TIME-1 trial, a pivotal Phase III study of tanespimycin as a potential treatment for multiple myeloma, has opened for enrollment. The evaluation is comparing the firm's Hsp90 inhibitor in combination with bortezomib versus bortezomib alone in patients following a single prior course of treatment (first-relapse).

Kosan says it has completed both a Special Protocol Assessment with the US Food and Drug Administration and a Scientific Advice process with the Committee for Medicinal Products for Human Use (CHMP) of the centralized European Medicines Agency (EMEA), thus providing what the company believes is a validated path to registration in many major world markets for the TIME-1 trial, which is the most advanced Hsp90 inhibitor clinical program in the industry, the firm noted.

The TIME registration program is designed to include two trials: a pivotal Phase III evaluation (TIME-1) and a smaller supportive study. The TIME-1 trial is proceeding on track and remains the foundation of the company's registration strategy. The TIME-2 study, recently opened for patients who have failed at least three prior myeloma therapies, will be closed and replaced with an alternative supportive trial. TIME-2 had been designed to support TIME-1 for full approval as well as to provide a potential strategy for pursuing accelerated clearance. Kosan believes that adjusting the design of the supportive trial to include a less heavily-pre-treated patient population that is more likely to respond will increase the probability of clinical success in the program.