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Disappointing Results for Perifosine

Perifosine was no better than a placebo in improving survival time for people with late-stage colorectal cancer according to a news release from Keryx Biopharmaceuticals.

Despite success in a smaller Phase II clinical trial, the X-PECT Phase III trial failed to meet its primary objective — longer survival time.

X-PECT randomized 468 patients to receive either:

  • Xeloda® (capecitabine) plus perifosine, or
  • Xeloda plus a placebo

Although final details were not provided, the perifosine group did not live longer than the patients who got a dummy pill.

Patients in the trial had refractory colorectal cancer, tumors that had already gotten worse on at least two standard chemotherapy regimens. Had perifosine helped increase survival time, it would have been a significant new treatment for patients who have exhausted all their standard treatment options.

Based on these results, Keryx will not be pursuing FDA approval for perifosine for refractory colorectal cancer.

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