Aeterna Zentaris and Keryx Biopharmaceuticals issue Phase 3 X-PECT Study update Print
By M.E.Garza   
Wednesday, 31 August 2011 08:43
Aeterna Zentaris Inc. (NASDAQ:AEZ) announced this morning that the independent Data Safety Monitoring Board (DSMB) for the pivotal Phase 3 X-PECT study of perifosine in patients with refractory advanced colorectal cancer has completed an interim analysis for safety and futility and that the board has recommended that the Phase 3 study continue to completion, as planned.

This Phase 3 study sponsored and conducted by our North American licensee for perifosine, Keryx Biopharmaceuticals, Inc., (NASDAQ:KERX) has completed enrollment, with over 465 patients from 65 U.S. sites. The study is being conducted pursuant to an SPA (Special Protocol Assessment) with the Food and Drug Administration (FDA) and with Fast-Track Designation. Furthermore, the Company has received positive Scientific Advice from the European Medicines Agency (EMA) for this ongoing Phase 3 trial, which is therefore expected to be sufficient for registration in Europe

The Phase 3 trial, entitled the "X-PECT" trial, is a randomized, double-blind trial comparing the efficacy and safety of perifosine + capecitabine vs. placebo + capecitabine in over 465 randomized patients with refractory advanced colorectal cancer. Patients must have failed available therapy. The primary endpoint is overall survival, with secondary endpoints including overall response rate (complete + partial responses), progression-free survival and safety. Approximately 360 events of death will trigger the unblinding of the study.

Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris, commented, "We are very pleased by the news that the DSMB has recommended that the study should proceed to completion as planned, and thank the DSMB members for their work. With this positive news we believe that our partner Keryx is well positioned to complete the Phase 3 program in refractory advanced colorectal cancer, which could bring this new therapy to patients suffering from this disease. We continue to prepare for the next steps and will work towards commercialization in the rest of the world."

Perifosine is a novel, oral anticancer treatment that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. The product works by interfering with membranes of cancer cells thereby inhibiting Akt signaling which then affects cell death, growth, differentiation and survival.  Perifosine rights have been licensed to Keryx for North America, to Yakult Honsha for Japan and to Handok for Korea.

The BioMedReports FDA Catalyst Calendar which tracks the clinical and regulatory progress of thousands of companies in the sector indicates that Aeterna Zentaris and Keryx Biopharmaceuticals anticipated the X-PECT study to be completed in the second half of 2011. A news update issued on 2/3/2010 by Keryx stated that enrollment was "expected to take approximately 12 months, with study completion expected in 2H 2011."

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