Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today the initiation of a Phase 3 registration clinical trial for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of patients with refractory advanced colorectal cancer.
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 approximately 430 patients with refractory advanced colorectal cancer. Patients must have failed available therapy including 5-fluorouracil (5-FU), oxaliplatin (Eloxatin®), irinotecan (Camptosar®), bevacizumab (Avastin®) and, if KRAS wild-type, failed therapy with prior cetuximab (Erbitux®) or panitumumab (Vectibix®). For oxaliplatin-based therapy, failure of therapy will also include patients who discontinued due to toxicity. The primary endpoint for this study is overall survival, with secondary endpoints including overall response rate, progression-free survival and safety. This trial is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration. Perifosine has also been granted Fast Track designation for the treatment of refractory advanced colorectal cancer.
Dr. Johanna Bendell, Director of GI Oncology Research for the Sarah Cannon Research Institute, Nashville, Tennessee, will lead the Phase 3 investigational team that includes Dr. Cathy Eng, Associate Medical Director for the Colorectal Center at MD Anderson Cancer Center in Houston, Texas.
Approximately 40 to 50 U.S. sites will participate in the study. Enrollment is expected to take approximately 12 to 14 months, with study completion expected in the second half of 2011.
Dr. Bendell stated, "We have now enrolled the first few patients on the Phase 3 X-PECT trial, which provides an important clinical trial option for patients with refractory advanced colorectal cancer. The randomized Phase 2 data showed promising activity of perifosine plus capecitabine compared to placebo plus capecitabine. I believe the X-PECT trial will soon provide us an answer as to the role of perifosine in the treatment of patients with refractory colorectal cancer."
Ron Bentsur, CEO of Keryx Biopharmaceuticals, commented: "Keryx is committed to developing perifosine as a treatment that will provide meaningful therapeutic value for patients living with refractory advanced colorectal cancer. The Phase 2 trial conducted in this setting provides strong rationale for the benefit of the perifosine/capecitabine combination in the treatment of advanced refractory colorectal cancer and we are extremely excited to initiate this Phase 3 registration trial, pursuant to our SPA, with the goal of potentially having the drug on the market for this indication by mid-2012. We would like to thank Dr. Bendell, Dr. Eng and the team of colorectal investigators for the rapid initiation of this study and their invaluable guidance."
Perifosine is currently in a Phase 3 trial, under Special Protocol Assessment (SPA), for the treatment of relapsed/refractory multiple myeloma, with Orphan Drug Status and Fast Track Designation granted.
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. in the United States, Canada and Mexico.
Keryx Biopharmaceuticals, Inc.