Kosan agrees Phase III trial design with FDA

Through the FDA’s special protocol assessment (SPA) process, Kosan and the FDA have reached agreement on overall protocol design, primary efficacy endpoints and data analysis as well as aspects of expected labeling if the data from the pivotal trial are supportive and tanespimycin is approved by the FDA. The company said that it has also completed the “scientific advice” process with the centralized European Medicines Agency (EMEA).

Kosan’s registration program for tanespimycin has been initiated and includes two trials: one which will be conducted in a first-relapse patient population, and another which will evaluate the clinical benefit of adding tanespimycin to bortezomib. The Special Protocol Assessment Kosan has completed applies to the first study, known as TIME-1.

“Kosan’s successful completion of both the SPA process with the FDA and scientific advice from the EMEA for our TIME-1 trial provides us with a clear roadmap to registration in major countries around the world for this potentially important new treatment for patients with multiple myeloma,” said Robert Johnson, Jr, Kosan’s president and CEO.