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Æterna Zentaris Partner Keryx Reports a Statistically Significant Benefit in Survival from Updated Results of a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Perifosine (KRX-0401) in the Treatment of Advanced Metastatic Colon Cancer
Date:1/25/2010

herapy. Patients who remained on treatment longer in the Phase 2 study had a greater chance to develop hand-foot syndrome as illustrated by a median time to onset of Grade 3 and Grade 4 hand-foot syndrome in the P-CAP arm of 19 weeks.

Commenting on the data, Dr. Cathy Eng, Associate Medical Director for Colorectal Cancer at MD Anderson Cancer Center in Houston, Texas, stated, "This randomized Phase 2 trial demonstrates the very promising activity of perifosine (an oral AKT pathway inhibitor) for response, PFS, and OS in the care of previously treated, advanced colorectal cancer. Akt is downstream from the EGFR receptor and may have a role also in KRAS mutant tumor types. Preclinical data suggest that the Akt pathway inhibitors may be of benefit not only with chemotherapy but also in combination with other biologic agents. Perifosine is definitely worthy of further analysis and should be pursued in a Phase 3 trial in this indication."

Dr. Paulo Hoff, Professor of Medicine and Chairman of Medical Oncology at the University of Sao Paulo, Brazil and the lead investigator for the capecitabine (Xeloda(R)) Phase 3 approval study stated, "The data we see in this study for the capecitabine alone group is very much in line with expectation and, therefore, the combination data of perifosine plus capecitabine appears very compelling. It seems that the inhibition of Akt and other pathways by perifosine modulates the activity of capecitabine. What is of particular interest to me is the TTP and OS data for the 5-FU refractory patients, which holds great promise and I urge the Company to move forward into Phase 3."

Juergen Engel, Ph.D., President and CEO at Æterna Zentaris stated, "This is a very positive development to begin the Year 2010. We now have a lot of options to create val
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SOURCE AETERNA ZENTARIS INC.
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1. Æterna Zentaris Receives NASDAQ Notification Related to Minimum Bid Price
2. AEterna Zentaris Announces Termination of Agreement with sanofi-aventis U.S. for the Development, Commercialization and Licensing of Cetrorelix in Benign Prostatic Hyperplasia
3. AEterna Zentaris Partner, Keryx, Initiates Phase 3 Registration Trial with Perifosine (KRX-0401) for the Treatment of Patients with Advanced Multiple Myeloma
4. AEterna Zentaris Announces Appointment of New Board Member
5. 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
6. AEterna Zentaris Announces Results from its European Phase 3 Study with Cetrorelix in Benign Prostatic Hyperplasia
7. AEterna Zentaris Anti-Cancer Compound, Perifosine (KRX-0401), Receives FDA Fast Track Designation for the Treatment of Relapsed/Refractory Multiple Myeloma
8. AEterna Zentaris Announces Positive Results for Phase 2 Study with LHRH-Receptor Targeted Cytotoxic Conjugate AEZS-108 in Endometrial Cancer
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