FDAnews
www.fdanews.com/articles/97217-mmrc-proteolix-initiate-phase-ii-trial-for-carfilzomib

MMRC, Proteolix Initiate Phase II Trial for Carfilzomib

August 15, 2007

The Multiple Myeloma Research Consortium (MMRC) and Proteolix announced the enrollment of the first patient in a multicenter Phase II clinical trial to study Proteolix’s proteasome inhibitor, carfilzomib, in patients with relapsed and refractory multiple myeloma.

The trial will evaluate the overall response rate for two cycles of carfilzomib  (PR-171) in patients who have previously received specific FDA-approved therapies, have relapsed after two or more of such therapies and are refractory to the most recently received therapy, MMRC and Proteolix said.

Secondary objectives of this study include safety and tolerability, clinical benefit response, time to progression, duration of response, progression-free survival and best overall response rate throughout the study.

According to MMRC and Proteolix, patients enrolled in the trial will receive carfilzomib twice weekly for three weeks every 28 days.