Keryx Biopharmaceuticals Reports Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Co...(an doubled the ORR and almost doubled th...),Health

Although not a primary endpoint in the study, overall survival was analyzed with results as follows:

           Group               Median Overall Survival*            % change
                                     (months)
    Capecitabine + Perifosine     22  {95% CI (12.1, NR)}       26% Increase**

    Capecitabine + Placebo      16.3  {95% CI (5.3, 17.1)}

    *Survival calculated from date of randomization until date of death from
    any cause, whether or not additional therapies were received after removal
    from treatment.

    **As of May 2009, median overall survival in the perifosine + capecitabine
    patient group is ongoing with 10 of the 20 patients in this arm still
    alive.

Dr. Howard Burris, Chief Medical Officer and Director of Drug Development for the Sarah Cannon Research Institute, Nashville TN, an investigator involved in the Keryx-sponsored perifosine clinical program since 2004, remarked, "The results demonstrate that the addition of perifosine to capecitabine more than doubled time to progression and response rates, along with extending survival vs. capecitabine alone. Although not a large sample size, the data here is very interesting and next steps should be considered."

Ron Bentsur, Chief Executive Officer of Keryx, commented, "Patients with advanced metastatic colon cancer, who fail standard first and second line treatment, are truly in need of additional therapies. We are excited about the data as the combination of perifosine and capecitabine, two oral agents, appears to demonstrate superior clinical benefit over capecitabine alone in this advanced patient population. We will now explore plans to move this program forward in patients with advanced colorectal cancer." Mr. Bentsur added, "We wish to thank all the study investigators for th
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