Keryx Biopharmaceuticals, (Keryx) has initiated Phase 3 registration clinical trial for KRX-0401 (perifosine), a PI3K/Akt pathway inhibitor, in relapsed / refractory multiple myeloma patients.
The trial, entitled, ‘A Phase 3 Randomised Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib (Velcade) 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) and Dexamethasone.
Reportedly, the trial is expected to 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 FDA. Additionally, the FDA has granted perifosine Orphan Drug and Fast Track designations in this indication.
Ron Bentsur, CEO of Keryx, said: “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. We would like to thank Richardson, Anderson and the other clinical investigators involved for their dedication to the perifosine multiple myeloma development program.”
Dr Richardson, clinical director of the Jerome Lipper Multiple Myeloma Center, said: “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.”