AEterna Zentaris Inc., a global biopharmaceutical companyfocused on endocrine therapy and oncology, today announced that the FDA has granted Fast Track designation for thecompany's PI3K/Akt pathway inhibitor compound, perifosine (KRX-0401), for thetreatment of relapsed/refractory multiple myeloma. Keryx Biopharmaceuticals,Inc., is AEterna Zentaris' partner and licensee forperifosine in the United States, Canada and Mexico. Perifosine is alsoout-licensed to Handok in South Korea while AEterna Zentaris retains rightsfor the rest of the world.
The Fast Track program of the FDA is designed to facilitate thedevelopment and expedite the review of new drugs that are intended to treatserious or life-threatening conditions and that demonstrate the potential toaddress unmet medical needs. Fast Track designated drugs ordinarily qualifyfor priority review, thereby expediting the FDA review process.
"We are very pleased with the FDA's Fast Track designation and we lookforward to the emergence of the data from the forthcoming Phase 3 clinicaltrial in multiple myeloma to be conducted by our partner Keryx, which we hopewill establish perifosine as a novel treatment of this serious condition",stated Juergen Engel, Ph.D., President and CEO at AEterna Zentaris. "Wefurther believe that this North American clinical development program willalso be very useful to support the development and registration of perifosinefor the benefit of patients in the rest of the world."
A Phase 3 trial investigating perifosine in combination with bortezomib(VELCADE(R)) and dexamethasone for the treatment of patients withrelapsed/refractory multiple myeloma is expected to commence by year-end undera Special Protocol Assessment (SPA) with the FDA. In addition, in September,perifosine had received Orphan-Drug designation in the United States for thetreatment of multiple myeloma.