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 (Velcade(R)), 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.
Juergen Engel, Ph.D., President and CEO at AEterna Zentaris stated, "We are very excited with Keryx's initiation of this Phase 3 trial with perifosine, our lead oncology compound. Based on prior positive results, we believe that perifosine could become a novel oral combination treatment of great benefit to patients suffering from multiple myeloma."
About the Phase 3 Trial Design
The Phase 3 trial is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine to placebo when combined with bortezomib (Velcade(R)) and dexamethasone in approximately 400 patients with relapsed or relapsed/refractory multiple myeloma. Patients will be randomized to bortezomib (Velcade(R)) at 1.3 mg/m2 days 1, 4, 8 and 11 every 21 days in combination with dexamethasone 20 mg on the day of and day after bortezomib (Velcade(R)) treatment, and either pe
|SOURCE AETERNA ZENTARIS INC.|
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