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Novel drugs help solve Gleevec resistance

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Of six patients with advanced accelerated phase of the disease, three had a hematologic response: two were complete, and one patient showed no remaining evidence of leukemia.

One patient demonstrated resistance to BMS-354825, Talpaz reports. Side effects, which included reduced red and white blood cells and platelets, have been well tolerated, he says. Talpaz expects the efficacy of BMS-354825 to increase as more patients are enrolled and tested. "We haven't reached anything close to the maximum tolerated dose, yet we still are showing some remarkable activity," he says. "Very encouraging responses continue to be seen in the new cohort of patients recently enrolled."

Talpaz is co-principal investigator with Charles Sawyers, M.D., professor of medicine at UCLA, of a study that tested 29 patients with early-stage CML who are either resistant to Gleevec or who could not tolerate the drug's side effects. Their study is being presented by Dr. Sawyers in the first presentation at the meeting's plenary session.

The investigators found that in these patients, 73 percent experienced a complete hematologic response "and they have shown that the drug is capable of overcoming Gleevec resistance in the vast majority of cases which resistance is caused by a mutation in the BCR-ABL gene," Talpaz says.

"This is a remarkably high response rate," he says. "Also exciting is the fact that clinical responses matched very well to preclinical testing in animal models. A specific mutation that was resistant to BMS-354825 in the test tube and the animal model was associated with resistance in patients, whereas the other mutations did not induce resistance in the test tube or the patient.

This suggests that we may be able to 'tailor' therapy according to the molecular profile of the disease," Talpaz says. "That means different treatments may be proposed for different patient subsets based on molecular and biochemical screening."


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Contact: Nancy Jensen
nwjensen@mdanderson.org
713-794-1584
University of Texas M. D. Anderson Cancer Center
5-Dec-2004


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