Keryx on track to complete enrollment in pivotal phase 3 trial by year end

By Jennifer Lanning Drey

Portland, Ore., Nov. 13 - Keryx Biopharmaceuticals, Inc. expects to complete enrollment in a phase 3 pivotal clinical trial of Sulonex (sulodexide oral gelcap) by the end of the year, while also continuing to enroll patients in a phase 4 study of the drug, chief financial officer Ronald C. Renaud Jr. said at the JPMorgan Small/Mid Cap Conference in Boston on Monday.

Sulonex is Keryx's lead compound and is being developed as a treatment for diabetic nephropathy under a Special Protocol Assessment with the Food and Drug Administration.

The company hopes to recruit 1,000 patients for the phase 3 clinical trial and expects to receive FDA approval for the compound in the second half of 2008, he said.

The phase 4 clinical trial will be a long-term outcome study.

Previous clinical data have demonstrated that Sulonex has efficacy in diabetic nephropathy and a good safety profile, according to Renaud.

Renaud also said on Monday that during the next six to 12 months, Keryx plans to focus development of its lead oncology compound, KRX-0401 (perifosine), on two or three specific cancer types. The compound has been tested in a variety of cancer types to date.

In addition, Keryx is advancing Zerenex, an oral, inorganic, iron-based compound for the treatment of hyperphosphatemia, or elevated phosphate levels. The company plans to begin a comprehensive phase 3 clinical trial of the compound by the end of 2007, Renaud said.

The New York-based pharmaceutical company finished the third quarter with approximately $141 million in cash, he said.

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