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URL http://www.rockymountainbmt.com/news/Patients-with-treatment-resistant-leukemia-achieve-high-responses-to-Tasigna-nilotinib-in-first-published-clinical-trial-results-1782.html

Patients with treatment-resistant leukemia achieve high responses to Tasigna (nilotinib) in first published clinical trial results

07-17-2006

The first published clinical trial data about the investigational drug Tasigna (nilotinib) showed the compound helped more than 90% of patients diagnosed with an unresponsive form of leukemia.

The data were published in New England Journal of Medicine.

In less than five months of treatment, 92% of patients with chronic phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) achieved a complete hematologic response with normal white blood cell counts after having shown resistance or intolerance to optimized Gleevec (imatinib mesylate) tablets therapy.

In more than a third of these patients, the Ph chromosome, the genetic abnormality that characterizes most cases of CML, was undetectable after treatment with Tasigna, as measured by standard laboratory methods. A total of 106 patients with Ph+ CML participated in this study: 33 patients in blast crisis, 56 patients in accelerated phase, and 17 patients in chronic phase. In addition, 13 patients with Ph+ acute lymphoblastic leukemia were included in the study.

Both Tasigna and Gleevec inhibit Bcr-Abl, the definitive cause of Ph+ CML - in effect, shutting down production of the Ph chromosome. Tasigna was specifically designed to be a highly selective inhibitor of Bcr-Abl and its mutations, which can cause resistance to treatment.

Patients in the most advanced phases of CML also responded to Tasigna therapy. The overall rate of hematologic response (normalization of white blood cell counts) for patients in accelerated phase was 72% and the rate of cytogenetic response (reduction or elimination of the Ph+ chromosome) was 48%. Among patients in blast crisis, the response rates were 39% and 27%, respectively.

The study investigators concluded that Tasigna was generally well tolerated. Common adverse events included myelosuppression, transient indirect hyperbilirubinemia and skin rashes. Additionally, the investigators noted that Tasigna was usually not associated with certain toxicities seen with Gleevec (e.g. fluid retention, superficial edema, weight gain), or with rare cases of pleural and pericardial effusions.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2006, Biotech Business Week via NewsRx.com.