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AEterna Zentaris Partner, Keryx, Initiates Phase 3 Registration Trial with Perifosine (KRX-0401) for the Treatment of Patients with Advanced Multiple Myeloma
Date:12/16/2009

, 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.

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
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SOURCE AETERNA ZENTARIS INC.
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1. AEterna Zentaris Announces Appointment of New Board Member
2. AEterna Zentaris Partner, Keryx, Reports Updated Phase 1/2 Data, Including New Survival Data, on Perifosine (KRX-0401) in the Treatment of Advanced Multiple Myeloma at the 51st Annual Meeting of the American Society of Hematology
3. AEterna Zentaris Announces Results from its European Phase 3 Study with Cetrorelix in Benign Prostatic Hyperplasia
4. AEterna Zentaris Anti-Cancer Compound, Perifosine (KRX-0401), Receives FDA Fast Track Designation for the Treatment of Relapsed/Refractory Multiple Myeloma
5. AEterna Zentaris Announces Positive Results for Phase 2 Study with LHRH-Receptor Targeted Cytotoxic Conjugate AEZS-108 in Endometrial Cancer
6. AEterna Zentaris Receives US$5.5 Million from Institutional Investors
7. AEterna Zentaris to Raise US$5.5 Million from Institutional Investors at US$1.20 Per Share
8. AEterna Zentaris to Complete Phase 3 Clinical Trial of Macimorelin (AEZS-130) as First Oral Diagnostic Test for Growth Hormone Deficiency
9. AEterna Zentaris Announces Completion of Phase 1 Study with Oral AEZS-112 in Cancer
10. AEterna Zentaris Partner, Keryx Biopharmaceuticals, Receives Orphan-Drug Designation for Perifosine (KRX-0401) for the Treatment of Multiple Myeloma
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