Keryx Biopharma, FDA agree on design of late-stage trial for drug against colorectal cancer

Keryx, FDA agree on colon cancer drug study goals

NEW YORK — Keryx Biopharmaceuticals Inc. said Wednesday it reached an agreement with regulators on the design of a late-stage study of its cancer drug candidate perifosine.

The agreement makes it more likely the Food and Drug Administration will approve perifosine if it meets its goals in the clinical trial. The study will determine whether perifosine significantly increases survival in patients with colorectal cancer.

Keryx said it will begin the late-stage trial in the second quarter. It will compare a combination of perifosine and Roche’s cancer drug Xeloda to a combination of Xeloda and a placebo, and measure the effects of the drugs on overall survival.

The company said it will enroll about 430 patients who have colorectal cancer that has returned despite previous treatment, and has metastasized. It said median survival for those patients is about five months.

Keryx said enrollment will take about a year, and the study is expected to be complete in late 2011.

Perifosine was developed by Canadian drugmaker AEterna Zentaris Inc. Keryx has the rights to sell the drug in North America.

In midday trading, Keryx shares fell 2 cents to $2.68, and AEterna Zentaris shares gained a penny, to 87 cents.