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Keryx Biopharmaceuticals, Inc. Reports Phase 1/2 Data on KRX-0401 (Perifosine) at 50th Annual Meeting of American Society of Hematology
Date:12/9/2008

rse events have been seen. Toxicities were manageable with supportive care and/or dose reductions as required.

Overall Response Rate (ORR) which includes a minor response (MR) or better was the primary endpoint with Time to Progression (TTP) as a secondary endpoint. At the time of the presentation, 72 patients were evaluable for response. Evaluable patients were defined as those who had received at least two cycles of therapy on the combination of perifosine with bortezomib. Approximately 50% (35 / 72) of patients demonstrated progression at some point in their treatment and 20 mg dexamethasone (4 times per week) was added. Best response to either perifosine + bortezomib (+/-dexamethasone) for all 72 evaluable patients was as follows:

      Evaluable Patients    CR/nCR      PR        MR        ORR        SD**
    Perifosine +
     Bortezomib      72      2  3%    10  14%    5  7%    17   24%    16  30%
    With dex
     added*          35      1  1%     2   3%    7 10%    10   14%    13  11%
    Best Response  n=72      3  4%    12  17%   12 17%    27   38%    29  40%


    * as a subset of the evaluable population   **SD = greater than or equal
                                                        to 4 cycles

Median TTP for all study patients was 6.3 months. Median TTP for responding patients has not yet been reached, currently it is 8.8 months and on-going.

Particularly noteworthy was 52 (72%) of the evaluable patients were previously refractory (defined as progression on or within 60 days of treatment) to a bortezomib-based regimen, including 83% who were also refractory to the combination of bortezomib + dexamethasone. Response data for this bortezomib-refractory group was as follows:

         VELCADE(R)
          Refractory           CR/nCR     PR        MR       ORR        SD**
    Pe
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SOURCE Keryx Biopharmaceuticals, Inc.
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