Æterna Zentaris reported that Keryx has reached an agreement with FDA regarding a Special Protocol Assessment (SPA) on the design of a phase 3 trial for PI3K/Akt pathway inhibitor compound, perifosine (KRX-0401). It is for relapsed or relapsed/refractory multiple myeloma patients previously treated with bortezomib (VELCADE).
The SPA provides agreement that the phase 3 study design adequately addresses objectives in support of a regulatory submission.
The study entitled, A Phase 3 Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib and Dexamethasone in Multiple Myeloma Patients Previously Treated with Bortezomib, will be a double-blind, placebo-controlled study comparing the efficacy and safety of perifosine vs placebo, when combined with bortezomib and dexamethasone.
The trial would enroll approximately 400 patients with relapsed or relapsed/refractory multiple myeloma. The primary endpoint is progression-free survival whereas secondary endpoints include overall response rate, overall survival and safety.
Juergen Engel, president and CEO of Æterna Zentaris, said: We are very pleased and excited about perifosine moving forward into a Phase 3 trial. This represents a major milestone in our oncology drug development strategy which could hold great promise for patients with multiple myeloma.