Proteolix Presents Positive Clinical Data for Carfilzomib in Multiple Myeloma at the 2009 ASCO Annu...(yeloma (Abstract #8504). We ar...),Health

"We are excited by the positive demonstration of patient benefit achieved in our trials of carfilzomib. In particular, the response rates and duration of response among heavily pre-treated patients who lack treatment alternatives are highly encouraging," said Michael Kauffman, M.D., Ph.D., Chief Medical Officer of Proteolix. "Based on the consistent efficacy and safety profile achieved from our preclinical and clinical studies of carfilzomib, we are focused on advancing this promising novel agent through late-stage evaluation, with an eye toward an accelerated approval."

Trial Expanded for Accelerated Approval Strategy

Based on the positive data achieved in this Phase 2 trial, Proteolix has expanded the Phase 2 study to enroll an additional 250 relapsed and refractory multiple myeloma patients. If positive, results from this study could form the basis for a New Drug Application (NDA) filing for accelerated approval with the U.S. Food and Drug Administration in 2010.

Patients initially receive 20mg/m(2) carfilzomib twice a week over a 28-day cycle, followed by doses of 27mg/m(2) for every cycle thereafter for up to twelve cycles. The primary endpoint for the Phase 2 study is overall response rate, defined as a complete response (CR) or partial response (PR). Secondary endpoints include clinical benefit response (CR, PR or minor response (MR)), duration of response, progression-free survival, time to progression, overall survival and safety. To date, more than 140 patients have been enrolled in the study. Proteolix anticipates reporting results from this accelerated approval trial in the first half of 2010.

Carfilzomib Active in Single-Agent and Combination Regimens

Proteolix also presented data from two ongoing studies of carfilzomib in multiple myeloma patients during the Lymphoma and Plasma Cell Disorders poster session.

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