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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
Date:12/7/2009

ies (range 1 - 4) and 81% were previously treated with bortezomib plus dexamethasone); - 98% of patients were previously treated with dexamethasone; - 94% of patients were previously treated with lenalidomide (Revlimid(R)) and/or thalidomide (Thalomid(R)); and - 58% of patients had prior stem cell transplant.

Overall Response Rate (ORR), defined as the percentage of patients achieving a complete, partial or minor response (CR, PR or MR), was the primary endpoint, with Time to Progression (TTP), Progression-Free Survival (PFS), Overall Survival (OS) and Safety as secondary endpoints.

Seventy-three patients were evaluable for efficacy. Evaluable patients are defined as those patients who had received at least two cycles of therapy on the combination of perifosine with bortezomib. Of the 73 evaluable patients, 53 patients (73%) were previously refractory to bortezomib (defined as progression on or within 60 days of treatment to a bortezomib-based regimen), including 44 patients who were refractory to the combination of bortezomib + dexamethasone. Twenty evaluable patients (27%) were relapsed to a prior bortezomib-based regimen. Best response for all 73 evaluable patients was as follows:

    -------------------------------------------------------------------------
    Evaluable Patients   CR/nCR*   PR         MR        ORR       SD**
    -------------------------------------------------------------------------
    All Evaluable
    Patients
     (n=73)   3   4%   13   18%   14   19%   30   41%   30   41%
    -------------------------------------------------------------------------
    Bortezomib Relapsed
     (n=20)   2  10%    7   35%    4   20%   13   65%    7   35%
    -------------------------------------------------------------------------
    Bortezomib
     Refractory
     (n=53)   1   2%    6   11%   10   19%   17   32%   23   43%
    --------------------------------------------------------------
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SOURCE  AETERNA ZENTARIS INC.
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