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Keryx Biopharmaceuticals, Inc. Reports Updated Phase 1/2 Data, Including New Survival Data, on KRX-0401 (Perifosine) in the Treatment of Advanced Multiple Myeloma at the 51st Annual Meeting of the American Society of Hematology
Date:12/7/2009

r 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%
   ----------   ---  ---   ---  ---   --- ---    --- ---    --- ---

*   nCR = Near Complete Response is defined as meeting the criteria
    for CR (non-detectable monoclonal protein by serum and urine),
    except with detectable monoclonal protein by immunofixation.
**  SD = Stable Disease for a minimum of 3 months.

Approximately 60% (45 / 73) of patients demonstrated progression (or SD for 4 cycles) at some point in their treatment and received 20 mg dexamethasone, four times per week, in addition to perifosine plus bortezomib. Responses occurred both with patients taking perifosine in co
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SOURCE Keryx Biopharmaceuticals, Inc.
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