The TIME registration program is designed to include two trials, a pivotal Phase III trial (TIME-1) and a smaller supportive trial. The TIME-1 trial is proceeding on track and remains the foundation of the company’s registration strategy. The TIME-2 trial, recently opened for patients who have failed numerous (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 approval.
TIME-1 is an open-label, randomized, multi-center, international Phase III trial comparing tanespimycin in combination with bortezomib (Velcade) with bortezomib alone in patients following a single prior course of treatment (first-relapse). The trial is designed with a primary endpoint of progression-free survival (PFS), and there are several predefined secondary endpoints. TIME-1 is powered to show a 2.75 month PFS benefit in the tanespimycin plus bortezomib group compared to the bortezomib alone group.