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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

citabine (a chemotherapy used in advanced metastatic colon cancer which is marketed by Roche as Xeloda(R)) at 825 mg/m2 BID (total daily dose of 1,650 mg/m2) on days 1 - 14 every 21 days plus either perifosine or placebo at 50 mg daily. The study enrolled a total of 38 patients, 34 of which were third-line or greater. Of the 38 patients enrolled, 35 were evaluable for response (20 patients on the perifosine + capecitabine arm and 15 patients on the placebo + capecitabine arm). Three patients on the placebo + capecitabine arm were not evaluable for response (2 patients were unevaluable due to toxicity (days 14, 46) and 1 was unevaluable due to a new malignancy on day 6). All patients in the perifosine + capecitabine arm were evaluable for response.

The patients in the study were heavily pre-treated, with the arms well-balanced in terms of prior treatment regimens. The median number of prior treatment regimens for all 38 patients was two, with prior treatment regimens for the P-CAP arm versus CAP arm shown in the table below. Notably, all of the patients (with the exception of one CAP arm patient) had been treated with FOLFIRI and/or FOLFOX, almost 80% treated with Avastin(R), and half treated with an EGFR antibody:

    -------------------------------------------------------------------------
    Prior RX              P-CAP                CAP        All Patients
                   (n equals 20)      (n equals 18)       (n equals 38)
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    FOLFIRI             18 (90%)           16 (89%)            34 (89%)
    -------------------------------------------------------------------------
    FOLFOX              15 (75%)           13 (72%)            28 (74%)
    -------------------------------------------------------------------------
    FOLFIRI & FOLFOX    13 (65%)           12 (67%)            25 (66%)
    ---------------------------------------------------------------
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SOURCE  AETERNA ZENTARIS INC.
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Related biology technology :

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
9. AEterna Zentaris Receives US$5.5 Million from Institutional Investors
10. AEterna Zentaris to Raise US$5.5 Million from Institutional Investors at US$1.20 Per Share
11. AEterna Zentaris to Complete Phase 3 Clinical Trial of Macimorelin (AEZS-130) as First Oral Diagnostic Test for Growth Hormone Deficiency
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