Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced the completion of patient recruitment for the ongoing Phase 3 trial with perifosine in refractory advanced colorectal cancer. The trial, involving over 430 patients, is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA) and with Fast Track Designation. It is sponsored by Keryx Biopharmaceuticals, Inc., (Keryx), (NASDAQ: KERX), Aeterna Zentaris' licensee for perifosine in North America. Perifosine is a novel, potentially first-in-class, oral anticancer drug candidate that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway.
Juergen Engel, Ph.D., Aeterna Zentaris President and Chief Executive Officer, commented, "We wish to congratulate our partner Keryx and thank all those involved in reaching this key patient recruitment milestone within a 16-month timeframe. We now look forward to the completion of this pivotal Phase 3 trial in order to potentially provide an additional treatment to refractory advanced colorectal cancer patients."
Phase 3 Trial Design
The Phase 3 trial, entitled the "X-PECT" (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment) trial, is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine vs. placebo + capecitabine in over 430 patients with refractory advanced colorectal cancer. Patients must have failed available therapy including 5-fluorouracil (5-FU), oxaliplatin (Eloxatin®), irinotecan, bevacizumab (Avastin®) and, if KRAS wild-type, failed prior therapy with cetuximab (Erbitux®) and/or panitumumab (Vectibix®). 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 un-blinding of the study.
Dr. Johanna Bendell, Director of GI Oncology Research for the Sarah Cannon Research Institute, Nashville, Tennessee, is Study Chair for the Phase 3 investigational team. Dr. Cathy Eng, Associate Medical Director for the Colorectal Center at MD Anderson Cancer Center in Houston, Texas, is the Lab Correlative Study Chair leading the biomarker analyses. Sixty-five U.S. sites are participating in the study.