Keryx Biopharmaceuticals announced data on the clinical activity of perifosine (KRX-0401) in combination with capecitabine as a treatment for advanced colon cancer. This trial was a randomized, double-blind, placebo-controlled study, enrolling 38 patients with second- or third-line metastatic colon cancer at 11 centers across the United States. Patients were randomized to receive Xeloda (capecitabine), an approved drug for metastatic colon cancer, on days 1-14 every 21 days, plus either perifosine or placebo at 50 mg daily. Treatment was continued until progression. 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 Overall Response Rate (defined as the percentage of patients achieving a complete response or partial response by RECIST) and almost doubled the Clinical Benefit Rate (defined as the percentage of patients on treatment for greater than three months with at least stable disease) vs. capecitabine + placebo.

Perifosine is a novel, potentially first-in-class, oral anti-cancer agent that modulates Akt, a protein in the body associated with tumor survival and growth. KRX-0401 also modulates a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival.

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