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Cyclacel reports updated Phase I sapacitabine data at 2007 ASH meeting

Dec 10 2007

Cyclacel reports updated Phase I sapacitabine data at 2007 ASH meeting

BERKELEY HEIGHTS, NJ, December 8, 2007 – Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP) reported today updated results from a Phase I clinical trial of sapacitabine (CYC682), a novel orally available nucleoside analog, at the 49th Annual Meeting of the American Society of Hematology, December 8 - 11, 2007 in Atlanta, Georgia. Data from this study demonstrated that sapacitabine had a favorable safety profile and promising anti-leukemic activity in patients with relapsed and refractory acute myelogenous leukemia (AML) and myelodysplastic syndromes (MDS) when administered by two different dosing schedules.

Abstract No. 884

"The updated results of this study are impressive in terms of the observed anti-leukemic activity and good tolerability of sapacitabine," commented Dr. Kantarjian, the study's principal investigator. "I believe these promising data warrant further clinical development of sapacitabine for the treatment of AML and MDS."

The primary objective of the study is to determine the maximum tolerated dose (MTD) of sapacitabine administered twice daily for seven consecutive days every 21 days or three consecutive days per week for two weeks every 21 days. The MTD was reached at 375 mg on the seven-day schedule and 475 mg on the 3-day schedule. Dose-limiting toxicity was gastrointestinal which included abdominal pain, diarrhea, small bowel obstruction and neutropenic colitis. One patient treated at the MTD of 375 mg on the seven-day schedule died of complications from neutropenic colitis. Among 46 patients with AML (n=42) or MDS (n=4) in this dose escalating study, the best responses were complete remissions (CR) or complete remissions without platelet recovery (CRp) in six patients. In addition, 15 patients had a significant decrease in bone marrow blasts including seven with blast reduction to 5% or less.

The study is ongoing at The University of Texas M. D. Anderson Cancer Center and is led by Dr. Hagop Kantarjian, Professor of Medicine and Chairman of the Leukemia Department and Dr. William Plunkett, Professor and Chief, Section of Molecular and Cellular Oncology, Department of Experimental Therapeutics.

Based on the encouraging anti-leukemic activity observed in this study, Cyclacel plans to open a multicenter randomized Phase II clinical trial later this month of oral sapacitabine in elderly patients with acute myeloid leukemia who are previously untreated or in first relapse. The primary objective of this study is to evaluate the one-year survival rate of three dosing schedules. The study will use a selection design to identify a dosing schedule that produces a better one-year survival rate in the event that all three dosing schedules are active.

Abstract No. 884

About Sapacitabine

Sapacitabine appears to act through a dual mechanism. It interferes with DNA synthesis by causing single-strand DNA breaks and also induces arrest of cell cycle progression mainly at G2/M-Phase. Both sapacitabine and CNDAC, its major metabolite or a substance into which the drugs converts after ingestion by patients, have demonstrated potent anti-tumor activity in preclinical studies. In addition, in a mouse model of liver metastasis, sapacitabine was shown to be superior in terms of delaying the onset and growth of liver metastasis to either gemcitabine (Gemzar®; Lilly) or 5-FU, two widely used nucleoside analogs. Gemcitabine is indicated for the palliative treatment of breast, lung, ovarian and pancreatic cancer, but it has not been reported to be active in leukemias or MDS.

The reported study follows three Phase I trials in solid tumors or lymphomas involving over 120 patients which evaluated safety and pharmacokinetics of a variety of dosing schedules for future Phase II studies and combination studies with other anti-cancer agents. A Phase II study of sapacitabine in patients with advanced cutaneous T cell lymphoma is currently ongoing.

Sapacitabine is part of a deep pipeline of small molecule drugs designed to target and stop uncontrolled cell division. Cyclacel's other development programs include seliciclib, a CDK (cyclin dependent kinase) inhibitor in two randomized Phase II clinical trials for non-small cell lung cancer and nasopharyngeal cancer, and CYC116, an Aurora kinase and VEGFR2 inhibitor in Phase I development in patients with solid tumors.

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. Cyclacel's ALIGN Pharmaceuticals subsidiary markets directly in the U.S. Xclair® Cream for radiation dermatitis, Numoisyn® Liquid and Numoisyn® Lozenges for xerostomia. Three Cyclacel drugs are in clinical development. Sapacitabine (CYC682), an orally-available, cell cycle modulating nucleoside analog, is in Phase II for the treatment of cutaneous T-cell lymphoma (CTCL) and in Phase I in patients with hematologic malignancies. Seliciclib (CYC202), an orally-available CDK (cyclin dependent kinase) inhibitor, is in two randomized Phase II studies for the treatment of lung cancer and nasopharyngeal cancer. CYC116, an orally-available, Aurora kinase and VEGFR2 inhibitor, is in Phase I development in patients with solid tumors. Several additional programs are at an earlier stage. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in oncology, hematology and other therapeutic areas based on a portfolio of commercial products and a development pipeline of novel drug candidates.

Please visit http://www.cyclacel.com/cyc/investors/news/pressreleases for additional information. Note: The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc. Numoisyn® and Xclair® are trademarks of Sinclair Pharma plc.

Forward-Looking Statements & 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, 2006, as supplemented by the interim quarterly reports, filed with the SEC.

Contacts for Cyclacel:

Investors:  
Cyclacel Pharmaceuticals, Inc. (908) 517-7330
Corey Sohmer  
   
Media:  
WeissComm Partners (312) 654-6763
Aline Schimmel