Keryx starts clinical studies of KRX-0401 in patients with multiple myeloma

By E. Janene Geiss

Philadelphia, Jan. 3 - Keryx Biopharmaceuticals, Inc. announced Tuesday the start of a corporate-sponsored clinical program to evaluate KRX-0401 (perifosine) as a treatment for multiple myeloma.

This follows positive preclinical data demonstrating perifosine as active against human multiple myeloma cell lines and freshly isolated plasma cells from multiple myeloma patients' bone marrow, including those cells that were resistant to dexamethasone and doxorubicin, according to a company news release.

Perifosine was shown to modulate a number of key cellular functions involved in the replication and death of multiple myeloma cells, and as in other cell lines, it was shown to be a potent Akt inhibitor, officials said.

Perifosine was active in vitro and in vivo when used alone, and it appeared to be synergistic when combined with either bortezomib (Velcade) or dexamethasone, officials said.

The open-label phase 2 study will evaluate the safety and efficacy of perifosine [KRX-0401] alone and in combination with dexamethasone for patients with relapsed or relapsed/refractory multiple myeloma.

This is a multi-center study led by Paul Richardson, clinical director of the Jerome Lipper Myeloma Center at the Dana-Farber Cancer Institute in Boston.

In the study, patients will receive 150 mg KRX-0401. If a patient progresses on KRX-0401 alone, dexamethasone (20 mg twice weekly) will be added to the regimen.

This study is similar in design to the Velcade pivotal phase 2 program for which Richardson also served as principal investigator, officials said.

"KRX-0401 is a novel compound with a unique mechanism of action that has demonstrated compelling activity in what we believe are highly predictive multiple myeloma preclinical models. We are eager to explore its potential in treating and hopefully benefiting our patients with relapsed or relapsed/refractory myeloma," Richardson said in the release.

Another Keryx-sponsored multiple myeloma clinical study to be launched in the first half of 2006 also will be led by the Dana Farber Cancer Institute. The phase 1/2 study evaluating the safety and efficacy of KRX-0401 and bortezomib (Velcade) therapy with or without dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with bortezomib (Velcade), officials said.

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

Keryx is a New York City pharmaceutical company focused on the acquisition, development and commercialization of new products to treat life-threatening diseases, including diabetes and cancer.

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