Clinical trial is being conducted by the Fred Hutchinson Cancer Research Center and the University of Washington June 18, 2012 Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) today announced that the University of Washington ("UW") has begun enrolling patients in a randomized phase II study testing the combination of tosedostat with either cytarabine or decitabine for elderly patients with newly-diagnosed acute myeloid leukemia ("AML") or high-risk myelodysplastic syndrome ("MDS").
Drs. John Pagel and Elihu Estey, from the University of Washington School of Medicine and Fred Hutchinson Cancer Research Center, are leading the study.
"This is the first study to examine the effects of tosedostat in combination with either cytarabine or decitabine as a first-line therapy. The study will evaluate how well patients tolerate these combinations, and their effectiveness. Given that there have been no major advances in treatment of elderly patients with AML, and the results of a previous study of tosedostat by itself in relapsed or refractory patients with AML or MDS showed promising anti-leukemic effects and acceptable tolerability, we are hopeful that this study will demonstrate that tosedostat increases the limited efficacy of these commonly used anti-leukemic agents," Dr. Estey said.
The study's primary objectives are to determine the four-month survival and complete response ("CR") rates of tosedostat in combination with either cytarabine or decitabine in untreated AML or high-risk MDS. The study's secondary objectives are to assess the safety and tolerability of tosedostat in combination with either cytarabine or decitabine, to determine the treatment-related mortality rate (defined as death within the first 30 days of beginning treatment), and to estimate the rates of disease-free survival, one-year survival, and overall survival.
About the Study
Each arm of the study will enroll up to 20 patients, with the possibility of enrolling an additional five patients each (for a maximum of 25 per arm), if an arm is not closed. Those eligible for the trial are adults with newly-diagnosed AML (including those with high-risk MDS). Patients with certain favorable AML features would be excluded from the study.
Patients interested in participating in this study or wanting more information can call Carol Dean (FHCRC) at (206) 667-1926.
About Acute Myelogenous Leukemia (AML)
AML is a cancer characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. AML is the most common acute leukemia affecting adults, and its incidence increases with age.
The symptoms of AML are caused by replacement of normal bone marrow with leukemic cells, which causes a drop in red blood cells, platelets, and normal white blood cells leading to infections and bleeding. AML progresses rapidly and is typically fatal within weeks or months if left untreated. Although a substantial proportion of younger individuals who develop AML can be cured, AML in the elderly typically responds poorly to standard therapy with few complete remissions.
Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated significant anti-tumor responses in blood-related cancers and solid tumors in phase I-II clinical trials. CTI has exclusive marketing and co-development rights to Chroma Therapeutics Ltd.'s drug candidate tosedostat in North, Central and South America
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.celltherapeutics.com/. Sign up for email alerts and get RSS feeds at CTI's Web site, http://www.CellTherapeutics.com/investors_alert
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of tosedostat include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with tosedostat in particular including, without limitation, the potential failure of tosedostat to prove safe and effective for the treatment of elderly patients with newly-diagnosed AML or high-risk MDS (including when administered in combination with cytarabine or decitabine) as determined by U.S. Food and Drug Administration and/or the European Medicines Agency, the potential failure of combination studies of tosedostat with hypomethylating agents in treating AML and/or MDS, that the phase II study of tosedostat may not achieve its primary and/or secondary objectives, that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials or the total number of patients enrolled, determinations by regulatory, patent, and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing, and selling tosedostat, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Clinical Trial Enrollment Contact:
Carol DeanT: (206) 667-1926E: email@example.com
Dan Eramian T: 206.272.4343C: 206.854.1200E: firstname.lastname@example.org.CellTherapeutics.com/press_room
Ed BellT: 206.282.7100Lindsey Jesch LoganT: 206.272.4347F: 206.272.4434E: email@example.com.CellTherapeutics.com/investors
Medical Information Contact:
T: 800.715.0944E: firstname.lastname@example.org
SOURCE Cell Therapeutics, Inc.
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