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Drug offers new options for leukemia patients

Dasatinib, an experimental drug under development by Bristol-Myers Squibb, reverses the signs and symptoms of patients whose chronic myeloid leukemia has failed to respond to Gleevec, which is considered the standard of treatment for the disorder.

In a study published in the June 15, 2006, issue of the New England Journal of Medicine (NEJM), Howard Hughes Medical Institute (HHMI) researchers at the University of California, Los Angeles, and colleagues at M.D. Anderson Cancer Center and Bristol-Myers Squibb in Princeton, NJ, report data from phase I human clinical trials of the compound, dasatinib (BMS-354825). Phase I clinical trials evaluate drug safety and toxicity at different dose levels in a small number of volunteers.

The studies published in NEJM indicate that dasatinib can be used to overcome Gleevec resistance in patients who have chronic myeloid leukemia (CML). Patients enrolled in the study had experienced a worsening of the disease or intolerance when treated with Gleevec.

Study leader, HHMI investigator Charles L. Sawyers, and colleagues at UCLA's Jonsson Comprehensive Cancer Center, report that dasatinib successfully circumvented Gleevec (imatinib) resistance in 68 of 84 patients treated with the drug during phase I clinical trials at UCLA and M.D. Anderson Cancer Center. Resistance to Gleevec develops when patients acquire mutations in an enzyme that is targeted by Gleevec.

"(The studies) provide immediate hope for patients in whom CML cells have developed resistance to imatinib," wrote HHMI investigator Brian J. Druker of Oregon Health and Science University in an accompanying editorial in NEJM. "They show that the pace of new drug development can be impressively rapid."

In early June 2006, the Food and Drug Administration's Oncologic Drugs Advisory Committee voted to recommend accelerated approval of dasatinib for the treatment of adults in all phases of CML with resistance or intolerance to prior therapy. The committee base
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Contact: Jim Keeley
keeleyj@hhmi.org
301-215-8858
Howard Hughes Medical Institute
14-Jun-2006


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