|View printer-friendly version|
|Study of Cell Therapeutics' Tosedostat for Elderly Patients with Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome Now Enrolling|
"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
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
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
Clinical Trial Enrollment Contact:
Medical Information Contact: