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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

mbination with bortezomib and with patients receiving the combination plus dexamethasone. Best response for each group was as follows:




   Best Response      CR /nCR       PR        MR        ORR*      SD*
   -------------      -------    --------   -------   -------   -------
    Perifosine +
 Bortezomib (n=73)     2   3%    10   14%    6   8%   18  25%   19  26%
 -----------------    --- ---    ---  ---   --- ---   --- ---   --- ---
Dexamethasone added
       (n=45)          1   2%     6   13%   10  23%   17  38%   14  31%
-------------------   --- ---    ---  ---   --- ---   --- ---   --- ---

*   5 patients achieved an initial response on Perifosine +
    Bortezomib alone, and subsequently responded again with the addition
    of Dexamethasone.  3 additional patients achieved stable disease on
    Perifosine + Bortezomib alone, and subsequently achieved stable
    disease again with the addition of Dexamethasone.

Reported for the first time was median Progression-Free Survival (PFS) and Overall Survival (OS) data for all evaluable patients, as follows:




     Evaluable Patients           Median PFS*            Median OS**
     ------------------           -----------            -----------


                                   6.4 months             25 months
     All Evaluable Patients        ----------             ---------
              (n=73)            95% CI (5.3, 7.1)      95% CI (15.5, NR)
     ----------------------     -----------------      -----------------

      NR = Not Reached
*  Median PFS and median TTP were identical, as no patient deaths
   occurred prior to progression.
** Kaplan Meier methodology was used to determine overall survival
   figures.

Of particular interest was the comparison of evaluable patients who were previously refractory and the patients who were relapsed to a bortezomib-based regimen.

Median PFS and OS for bortezomib relapsed vs. refractory were as follows:
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SOURCE Keryx Biopharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

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