Keryx starts phase 2 study of KRX-0401 for the treatment of refractory leukemia

By Elaine Rigoli

Tampa, Fla., March 2 - Keryx Biopharmaceuticals, Inc. announced Thursday the beginning of a corporate-sponsored, phase 2, multi-center clinical program to evaluate KRX-0401 (perifosine) as a leukemia treatment.

This study will assess the objective response rate and evaluate the pharmacokinetics and safety and tolerability of perifosine as a single agent in relapsed or refractory acute myeloid leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, high-risk myelodysplastic syndrome and chronic myeloid leukemia in the blastic phase, according to a company news release.

The principal investigator for the study is Dr. Frank Giles, professor, department of leukemia, at the M.D. Anderson Cancer Center in Houston.

This is the second study to be launched under the company's corporate-sponsored hematological clinical program, which was announced earlier this year in connection with the initiation of a multi-center phase 2 study evaluating perifosine as a treatment for multiple myeloma, the release said.

The company said it anticipates launching other hematological studies in the first half of 2006.

KRX-0401 is in-licensed by Keryx from AEterna Zentaris, Inc. in the United States, Canada and Mexico.

New York City-based Keryx is focused on the acquisition, development and commercialization of novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer.

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