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.