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News Release

Cyclacel announces completion of enrollment in Phase 2 trial of sapacitabine in elderly AML

Oct 09 2008

Cyclacel announces completion of enrollment in Phase 2 trial of sapacitabine in elderly AML

BERKELEY HEIGHTS, NJ – October 9, 2008 – Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP) announced today the completion of enrollment as per protocol in the Phase 2 clinical trial of sapacitabine, the Company's oral nucleoside analogue, in elderly patients with acute myeloid leukemia (AML). Interim results from this trial are expected to be available by the end of 2008 and final results during the second half of 2009.

"The randomized Phase 2 study of sapacitabine in patients with elderly AML and myelodysplastic syndromes (MDS) achieved its enrollment target of the AML stratum in accordance with the protocol approximately three months ahead of forecast," said Dr. Judy Chiao, M.D., Vice President, Clinical Development and Regulatory Affairs of Cyclacel. "We are grateful for the contributions of our investigators, their colleagues and patients who helped us achieve this important milestone. An unmet medical need exists for patients who are 70 years of age or older and are suffering from AML that are previously untreated or in first relapse. If the results of this study demonstrate clinical benefit, sapacitabine could emerge as an important treatment for this life-threatening disease."

"The rapid enrollment is a testimony to the enthusiasm and support shown by investigators and patients participating in this study. Elderly AML patients have a poor prognosis and are often too frail to tolerate conventional chemotherapy," commented Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "During a satellite symposium entitled "Successfully Treating Every AML Patient" at the Leukemia 2008 conference (September 27, 2008, Houston, Texas), hematology thought leaders emphasized the importance of improving the treatment outcomes of such patients. In addition to elderly AML, we continue to enroll patients in the second line treatment of MDS stratum as part of our broad program of developing sapacitabine as a new therapeutic option for these underserved patient groups."

Cyclacel is currently enrolling patients in an open-label, multicenter, randomized Phase 2 trial of oral sapacitabine with two separate strata: elderly patients with AML who are previously untreated or in first relapse and MDS patients who have been previously treated with hypomethylating agents. In total the trial will enroll approximately 120 patients with approximately 60 patients in each stratum.

The primary objective of the study is to evaluate the one-year survival rate of three dosing schedules of sapacitabine. Secondary objectives are to assess the number of patients who achieve a complete remission (CR), complete remission without blood count recovery (CRi), hematological improvement and their corresponding durations, transfusion requirements, number of hospitalization days and safety. The study uses a selection design with the objective of identifying a dosing schedule which produces a better one-year survival rate for each stratum in the event that all three dosing schedules are active.

About Cyclacel Pharmaceuticals, Inc.

Cyclacel is a biopharmaceutical company dedicated to the discovery, development and commercialization of novel, mechanism-targeted drugs to treat human cancers and other serious disorders. Three orally-available Cyclacel drugs are in clinical development. Sapacitabine (CYC682), a cell cycle modulating nucleoside analog, is in Phase 2 studies for the treatment of acute myeloid leukemia in the elderly, myelodysplastic syndromes and cutaneous T-cell lymphoma. Seliciclib (CYC202 or R-roscovitine), a CDK (cyclin dependent kinase) inhibitor, is in Phase 2 for the treatment of lung cancer and nasopharyngeal cancer and in Phase 1 in combination with Tarceva®. CYC116, an Aurora kinase and VEGFR2 inhibitor, is in Phase 1 in patients with solid tumors. Several additional programs are at an earlier stage. Cyclacel's ALIGN Pharmaceuticals subsidiary markets directly in the U.S. Xclair® Cream for radiation dermatitis, Numoisyn™ Liquid and Numoisyn™ Lozenges for xerostomia. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology, oncology and other therapeutic areas based on a portfolio of commercial products and a development pipeline of novel drug candidates.

Please visit www.cyclacel.com for additional information. Note: The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.; Numoisyn™ and Xclair® are trademarks of Sinclair Pharma plc; Tarceva® is a trademark of OSI Pharmaceuticals, Inc.

Risk Factors

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety, and intended utilization of Cyclacel's product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, the risk that Cyclacel will not obtain approval to market its products, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. These factors and others are more fully discussed under "Risk Factors" in the Annual Report on Form 10-K for the year ended December 31, 2007, as supplemented by the interim quarterly reports, filed with the SEC.

Contacts for Cyclacel:

Cyclacel Pharmaceuticals, Inc. WeissComm Partners College Hill, Life Sciences
Corey Sohmer Aline Schimmel Sue Charles & Justine Lamond
(908) 517-7330 (312) 646-6295 +44 (20) 7866 7857