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Keryx Biopharmaceuticals, Inc. Reports Updated Phase 1/2 Data on KRX-0401 (Perifosine) in Combination with Bortezomib (+/- Dexamethasone) at the 12th International Multiple Myeloma Meeting
Date:2/26/2009

ell transplant. No unexpected adverse events have been seen. Toxicities were manageable with supportive care and/or dose reductions as required.

Best response (MR or better) and stable disease (no progression for 3 months) to either perifosine + bortezomib (+/-dexamethasone) for patients previously relapsed from or refractory to prior bortezomib treatment was as follows:

    Evaluable Patients         CR        PR        MR       ORR     SD > 3 mos
    Bortezomib Relapsed
     (n=20)                  2   10%   6   30%   3   15%  11   55%   9   45%
    Bortezomib Refractory
     (n=53)                  1    2%   6   11%  10   19%  17   32%  24   45%
    All Evaluable Patients
     (n=73)                  3    4%  12   16%  13   18%  28   38%  33   45%

Patients who had previously relapsed on a bortezomib-based treatment had a median time to progression (TTP) of 8.5 months. The median TTP for all 73 evaluable study patients (both bortezomib relapsed and refractory) was 6.4 months. As of the report, 16 patients remain on active treatment.

Commenting on the data, Dr. Paul Richardson stated "Perifosine in combination with bortezomib and dexamethasone continues to demonstrate an impressive response rate and time to progression in a heavily pre-treated patient population, with 83% of evaluable patients achieving stable disease or better. Particularly noteworthy is the benefit observed in patients who relapsed on prior bortezomib-based therapy, as reflected by an 8.5 month median time to progression in our study. We continue to be encouraged by the data and look forward to evaluating this combination in a randomized phase 3 trial."

Michael S. Weiss, Chairman and CEO of Keryx Biopharmaceuticals, remarked, "We believe these data confirm the activity of perifosine both in patients who have relapsed following bortezomib therapy and in those patients who were refractory to bort
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SOURCE Keryx Biopharmaceuticals, Inc.
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