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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

rifosine 50 mg daily or placebo. The Phase 3 trial design is based on positive data reported from the Phase 1/2 trial which was recently reported at the 51st American Society of Hematology meeting.

Patients eligible for the Phase 3 trial must have been previously treated with both bortezomib (Velcade(R)) and an immunomodulatory agent (Revlimid(R) and/or Thalidomid(R)), and been previously treated with one to four prior lines of therapy. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. Patients can be relapsed from and refractory to all non-bortezomib based therapies, however, patients can only be relapsed (progressed more than 60 days after discontinuing therapy) from prior bortezomib-based therapies. The study is powered at 90% to demonstrate the required difference in progression-free survival between the two arms. Approximately 265 events (defined as disease progression or death) will trigger the un-blinding of the data.

The Company expects a patient recruitment period of approximately 16-18 months, with study completion expected within approximately 20-22 months from today.

About Perifosine (KRX-0401)

Perifosine is a novel oral anticancer agent that modulates several key signal transduction pathways, including Akt, MAPK, and JNK that have been shown to be critical for the survival of cancer cells. Perifosine has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. Perifosine is currently in a Phase 3 trial, under Special Protocol Assessment (SPA), in multiple myeloma for which it has received Orphan Drug and Fast Track designations from the FDA in this indication. Perifosine is also in Phase 2 clinical trials for several other tumor types.

About Multiple Myeloma

Multiple myeloma, a cancer of the plasma cell, is an incurable but t
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SOURCE AETERNA ZENTARIS INC.
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Related biology technology :

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
11. AEterna Zentaris to Present at Upcoming Rodman Renshaw Annual Global Investment Conference
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