BERKELEY HEIGHTS, N.J., Aug. 30, 2011 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYC) (Nasdaq:CYCCP) (Cyclacel or the Company), today announced that the first patient has been dosed in an investigator-initiated, translational, Phase 2 clinical study at The University of Texas MD Anderson Cancer Center. The objective of the study is to learn if oral sapacitabine capsules given in combination with two standard injectable drugs, cyclophosphamide and rituximab, or the "SCR regimen", can help control chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in up to 40 relapsed patients with leukemia cells containing the 11q22-23 chromosome deletion. Deletion at chromosome 11q22-23 is associated with deletion of the Ataxia Telangiectasia Mutated (ATM) gene, an important element of the homologous recombination DNA repair (HRR) pathway.Previous findings show that cells with HRR pathway defects are particularly sensitive to sapacitabine.Sapacitabine may therefore be of particular benefit to patients with ATM-defective blood cancers.
The study is led by William G. Wierda, M.D., Ph.D., Associate Professor of Medicine, Leukemia Department, Division of Cancer Medicine, and is based on translational work published by a group led by William Plunkett, Ph.D., Professor and Deputy Chair, Department of Experimental Therapeutics, both of MD Anderson.The trial is being funded by MD Anderson's Leukemia Department with Cyclacel contributing sapacitabine and a small grant to support the performance of certain exploratory diagnostic tests.
"As gene-based, personalized medicine approaches have in certain cases been developed and approved faster than traditional methods, we are encouraged by the prospect of tailoring treatment with sapacitabine to the genetic profile of an individual's cancer cells," said Spiro Rombotis, President and CEO of Cyclacel. "We have collaborated with Dr. Wierda, Dr. Plunkett and their teams for several years to study sapacitabine's effects on the DNA repair pathway.We thus welcome the opportunity to explore the hypothesis that the presence of 11q22-23 deletion may translate into clinical benefit for patients treated with the sapacitabine-based SCR regimen, while doing so in a fiscally responsible and collaborative manner. We look forward to the eventual outcome of this unique study and building our value proposition on data from Cyclacel's ongoing studies in both hematological malignancies and solid tumors, with emphasis on our SEAMLESS Phase 3 pivotal trial in patients with front-line acute myeloid leukemia (AML)."
The translational Phase 2 study is a single institution, single arm, trial of the SCR regimen in previously treated patients with CLL or SLL. The primary objective is to evaluate the overall response rate of the regimen based on the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria.Up to 40 patients will be enrolled at different dosing schedules under evaluation.Secondary endpoints include the evaluation of tolerability and toxicities, determination of duration of response, disease-free survival and overall survival.In addition the study will evaluate the association between response to the SCR regimen and ATM gene function in previously treated patients with CLL who have chromosomal deletion 11q22-23 by the fluorescence in-situ hybridization or FISH technique.The study will also evaluate other clinically-correlated pretreatment indicators with response and time-to-event outcomes.
surf's up......crikey
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