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Phase I Study Results of Investigational Agent BMS-354825 in Patients With Imatinib-Resistant or Intolerant Chronic Myelogenous Leukemia Presented at the 46th Annual Meeting of the American Society of Hematology

Posted on: Sunday, 5 December 2004, 21:00 CST

SAN DIEGO, Dec. 5 /PRNewswire-FirstCall/ -- Phase I data presented today at the 46th annual meeting of the American Society of Hematology showed that patients with Philadelphia chromosome positive chronic myelogenous leukemia (CML) who are resistant or intolerant to imatinib mesylate (Gleevec(R))* experienced hematologic and cytogenetic responses with Bristol-Myers Squibb Company's oral investigational anti-cancer agent BMS-354825.

The Phase I study is being conducted at UCLA's Jonsson Comprehensive Cancer Center in Los Angeles and at the MD Anderson Cancer Center in Houston by co-principal investigators Charles L. Sawyers, M.D., professor of medicine, division of Hematology/Oncology at the David Geffen School of Medicine at UCLA/Howard Hughes Medical Institute, and Moshe Talpaz, M.D., professor of medicine in the Department of Experimental Therapeutics at The University of Texas M.D. Anderson Cancer Center.

"BMS-354825, which was discovered and is being developed by Bristol-Myers Squibb, is still in the early stages of clinical development," said Elliott Sigal, M.D., Ph.D., chief scientific officer and president of Bristol-Myers Squibb's Pharmaceutical Research Institute. "We are committed to initiating the global Phase II program as rapidly as possible and are working with regulatory authorities to define trial criteria and full development timelines."

BMS-354825 is a rationally designed oral investigational agent that inhibits five tyrosine kinase proteins, including BCR/ABL, the protein that accounts for abnormal cell growth in CML, and SRC, proteins that may play a role in imatinib resistance.

"New treatment options are needed for patients with imatinib resistance across the chronic, accelerated and blast phases of CML," said Dr. Sawyers. Dr. Talpaz added, "Preliminary findings of this Phase I clinical trial are encouraging and provide a sound basis to support further study of this compound."

Phase I Study Results

BMS-354825 was given to patients with Philadelphia chromosome positive chronic, accelerated and blast phase CML (36, eight and 21 patients, respectively) who were resistant or intolerant to imatinib. Of the chronic phase patients, 86 percent demonstrated a complete hematologic response. In 29 patients for whom cytogenetic data were available, eight (28 percent) demonstrated a major cytogenetic response.

In the accelerated phase patient group, 75 percent demonstrated a hematologic response. To date, there were no cytogenetic responses in patients with accelerated disease. In the blast phase patient group, 79 percent demonstrated a hematologic response. Of 15 patients for whom cytogenetic data were available, 53 percent demonstrated a major cytogenetic benefit.

In the chronic phase population, three of 26 patients for whom data are available had grade 4 thrombocytopenia (a very low platelet count) requiring treatment modification and two patients were reported as having gastrointestinal bleeding possibly related to BMS-354825. Two patients in the blast phase had evidence of tumor lysis syndrome (a serious complication of cancer therapy that causes metabolic abnormalities) and one patient with accelerated phase CML had pneumonia, thought possibly related to BMS-354825. In all phases, additional side effects reported during the study included arthralgia, pyrexia, fatigue, peripheral edema, headache and diarrhea, and mild prolongation of the QT interval. To date, no patients have discontinued the Phase I study due to toxicity.

Information regarding participation in BMS-354825 clinical trials in the United States and Canada can be obtained by calling Bristol-Myers Squibb's toll-free number at 1-877-526-7327.

About CML

CML, also called chronic myeloid leukemia, is a cancer that starts in the bone marrow and invades the blood. The incidence of CML is 1.6 per 100,000 per year. The American Cancer Society estimates that 4,600 cases will be diagnosed in the United States this year. It is estimated that more than 16,000 patients in the United States are currently living with CML, which usually occurs in middle-aged adults (the average age is 50 years).

Patients in the accelerated and blast phases of CML have a poorer prognosis and higher imatinib resistance rates than patients in the chronic phase of CML. In the accelerated and blast crisis phases, 24 percent and 66 percent of patients, respectively, treated with imatinib 600 mg/day failed to reach hematologic remission, with 13 percent of patients in the chronic phase relapsing after 24 months.

About Bristol-Myers Squibb

Bristol-Myers Squibb is dedicated to the discovery, development and exhaustive exploration of innovative cancer fighting therapies designed to extend and enhance the lives of patients living with cancer. More than 40 years ago, Bristol-Myers Squibb built a unified vision for the future of cancer treatment. With expertise, dedication and resolve, that vision led to the development of a diverse global portfolio of anticancer therapies that are an important cornerstone of care today. Hundreds of scientists at Bristol-Myers Squibb's Pharmaceutical Research Institute are studying ways to improve current cancer treatments and identify better, more effective medicines for the future.

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that BMS-354825 will be submitted for regulatory approval, will receive regulatory approval, or, if approved, will be commercially successful. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2003 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

ASH Abstract Information

Abstract 1. Sawyers CL, Shah NP, Kantarjian HM, Donato N, Nicoll J, et al. Hematologic and Cytogenetic Responses in Imatinib-Resistant Chronic Phase Chronic Myeloid Leukemia Patients Treated with the Dual SRC/ABL Kinase Inhibitor BMS-354825: Results from a Phase I Dose Escalation Study. To be presented at the 46th annual meeting of the American Society of Hematology (ASH), December 5, 2004, San Diego.

Abstract 20. Talpaz M, Kantarjian HM, Shah NP, Donato N, Nicoll J, et al. Hematologic and Cytogenetic Responses in Imatinib-Resistant Accelerated and Blast Phase Chronic Myeloid Leukemia (CML) Patients Treated with the Dual SRC/ABL Kinase Inhibitor BMS-354825: Results from a Phase I Dose Escalation Study. To be presented at the 46th annual meeting of the American Society of Hematology (ASH), December 5, 2004, San Diego.

* Gleevec is a registered trademark of Novartis.

Bristol-Myers Squibb Company

CONTACT: media, Tracy Furey, office, +1-609-252-3208, or Kathy Baum,office, +1-609-252-4227, or onsite pager, 877-232-1908, or investors, JohnElicker, office, +1-212-546-3775, all of Bristol-Myers Squibb Company

Web site: http://www.bms.com/

Source: PRNewswire-FirstCall

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