Keryx Biopharmaceuticals Announces Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Co...(of the patients received prior FOLFIRI (...),Health

Date:6/1/2009

of the patients received prior FOLFIRI (Irinotecan + 5FU + Leucovorin); 74% prior FOLFOX (Oxaliplatin + 5FU + Leucovorin); 63% were previously treated with both FOLFIRI and FOLFOX; 77% received prior Avastin(R); and 43% prior Erbitux(R). Prior treatment with single agent capecitabine was excluded.

The primary endpoints of this study were to measure 1) Time to Progression (TTP); 2) Overall Response Rate (ORR), defined as the percentage of patients achieving a Complete Response (CR) or Partial Response (PR) by RECIST, and 3) Clinical Benefit Rate (CBR) defined as the percentage of patients on treatment for greater than three months with at least stable disease. Safety of perifosine + capecitabine vs. capecitabine + placebo in this patient population was evaluated as a secondary endpoint. Perifosine in combination with capecitabine was well tolerated with hand/foot syndrome (14%) and anemia (11%) as the highest reported grade 3/4 adverse events.

Best response and median time to progression of capecitabine + perifosine vs. capecitabine + placebo were as follows:

        Group                           SD > 12
                   N    CR   PR    ORR    Wks     CBR     Median TTP
                       N(%)  N(%)  N(%)   N(%)    N(%)      (wks)

    Capecitabine   20    1    3     4     11      15      28.9 weeks
     + Perifosine      (5%) (15%) (20%)  (55%)   (75%) {95% CI (13, 48.1)}
    Capecitabine
     + Placebo     15    0    1     1      5       6        11 weeks
                            (7%)  (7%)   (33%)   (40%) {95% CI (9, 15.9)}

Perifosine + capecitabine more than doubled time to progression vs. capecitabine + placebo with a statistically significant p-value = 0.0006. In addition, perifosine + capecitabine more than doubled the ORR and almost doubled the Clinical Benefit Rate vs. capecitabine + placebo.

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SOURCE Keryx Biopharmaceuticals, Inc. Copyright©2009 PR Newswire. All rights reserved

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