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Keryx Starts Phase II Trial for Rare Sarcomas Treatment


Posted on 2006-12-13 07:54:00



Keryx Biopharmaceuticals, Inc. has initiated a corporate-sponsored phase II clinical program to evaluate KRX-0401 (perifosine) as a treatment for rare sarcomas. This Phase II study will be conducted by the Sarcoma Alliance for Research through Collaboration (SARC) multi-center network, which includes nationally recognized sarcoma centers and investigators throughout the United States. Dr. Dejka M. Steinert, assistant professor in the Department of Sarcoma at MD Anderson Cancer Center in Houston, Texas will act as principal Investigator for the study.

This clinical trial is entitled "A Phase II Trial of Perifosine in Patients with Chemo-Insensitive Sarcomas." In this Phase II study, the single agent activity of KRX-0401 is being evaluated in patients with chondrosarcoma, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will be treated with KRX-0401 (100 mg oral daily) until disease progression. This study follows previous Phase I and Phase II trials of perifosine in patients with chemo-insensitive sarcoma that showed responding patients experienced very little toxicity and the duration of responses observed on both weekly and daily dosing schedules varied from 6 months to more than 18 months. Furthermore, some of the partial responses occurred in patients with sarcoma subtypes that have been traditionally unresponsive to conventional therapy.

Dr. Steinert stated, "Perifosine is a novel compound with a unique mechanism of action that in previous studies has demonstrated some activity in patients with sarcoma subtypes that have been traditionally unresponsive to conventional chemotherapy. We are eager to explore its potential in treating and hopefully benefiting patients with chemo-insensitive sarcomas."

Laurence Baker, DO, the executive director of the Sarcoma Alliance for Research through Collaboration (SARC), remarked, "SARC is pleased to participate in this evaluation, bringing together the strongest sarcoma clinical and research programs within the U.S. We seek to improve the therapeutic options for patients with sarcomas and are unique in that adolescents, young and older adults can participate in our clinical trials. We appreciate the opportunity to partner with Keryx Biopharmaceuticals on this important clinical trial."

Craig Henderson, MD, president of Keryx Biopharmaceuticals, commented, "We've now seen objective responses in several tumors types, including sarcoma and renal cell carcinoma, and what appears to be a prolongation in the time to progression in many more. The responses in these rare sarcomas are of particular interest because they so rarely respond to chemotherapy. We are pleased to be working with SARC because of their access to and experience in conducting trials in this patient population."

KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. in the U.S., Canada and Mexico.


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