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Keryx Biopharmaceuticals, Inc. Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) for Treatment of Patients with Advanced Multiple Myeloma

Home/Keryx Biopharmaceuticals, Inc. Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) for Treatment of Patients with Advanced Multiple Myeloma

Keryx Biopharmaceuticals, Inc. Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) for Treatment of Patients with Advanced Multiple Myeloma

Here is info about a newly organized Phase 3 study combining perifosine with Velcade:

NEW YORK, Dec 16, 2009 /PRNewswire-FirstCall via COMTEX/ — Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today the initiation of a Phase 3 registration clinical trial for KRX-0401 (perifosine), the Company’s PI3K/Akt pathway inhibitor, in relapsed / refractory multiple myeloma patients.

The trial, entitled, “A Phase 3 Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib (Velcade(R)) and Dexamethasone in Multiple Myeloma Patients Previously Treated with Bortezomib” is a double-blind, placebo-controlled trial comparing the efficacy and safety of perifosine vs. placebo when combined with bortezomib (Velcade(R)) and dexamethasone. The trial will enroll approximately 400 patients with relapsed or relapsed / refractory multiple myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. This trial is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA). Additionally, the FDA has granted perifosine Orphan Drug and Fast Track designations in this indication.

The Phase 3 trial is being led by the Principal Investigator, Dr. Paul Richardson, Clinical Director of the Jerome Lipper Multiple Myeloma Center, at Dana-Farber Cancer Institute (DFCI) in Boston, MA and Dr. Kenneth C, Anderson, Chief, Division of Hematologic Neoplasia at DFCI. An estimated 40 to 50 centers throughout the United States and select centers outside of the United States will be participating in this Phase 3 trial.

Dr. Richardson’s clinical research focuses on studying novel therapies for multiple myeloma. He was the lead investigator of the SUMMIT and APEX clinical trials that led to the FDA approval of bortezomib (Velcade(R)) for the treatment of multiple myeloma. More recently, he served as clinical trials core chair of the Multiple Myeloma Research Consortium, completing 5 years of service in the role this year. Dr. Anderson serves as Chair of the NCCN Multiple Myeloma Clinical Practice Guidelines Committee and chairs the scientific advisory board for the Multiple Myeloma Research Foundation. In addition to playing an integral role in the development and approval of bortezomib, Drs. Richardson and Anderson led both preclinical and early phase clinical trials for the immunomodulatory drug lenalidomide (Revlimid(R)), leading to its FDA approval in 2007 .

Ron Bentsur, Chief Executive Officer of Keryx, commented, “We are very excited to be initiating the first pivotal program, under an SPA, for perifosine, a novel, oral inhibitor of a critical target in cancer development and progression. This study initiation represents a major milestone for the Company and demonstrates the capabilities of our internal clinical team.” Mr. Bentsur added, “We would like to thank Dr. Richardson, Dr. Anderson and the other clinical investigators involved for their dedication to the perifosine multiple myeloma development program.”

Dr. Richardson stated, “Despite recent advances, multiple myeloma remains a devastating and challenging disease for which we believe combination treatment will be beneficial to the majority of patients. We are very encouraged by the perifosine + bortezomib combination in regards to overall response rate, progression-free survival and overall survival data observed to date. If the results from this Phase 3 study prove positive, we believe that this orally administered novel agent could make an important difference for patients with advanced multiple myeloma.”

Dr. Ken Anderson commented, “We are very excited to be leading this pivotal program alongside our multiple myeloma colleagues nationwide. Based on the synergies observed in preclinical models, and most importantly, the clinical data generated in the Phase 1/2 study, we believe the combination of perifosine with bortezomib can significantly improve patient outcomes in this disease.”

KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. in the United States, Canada and Mexico. In addition to multiple myeloma, other clinical development efforts with perifosine are focused in the areas of colorectal cancer, renal cell carcinoma and other tumor types.

If Dr. Anderson is excited, I’m excited!  More about perifosine tomorrow.  Feel good and keep smiling!  Pat