Cyclacel to Present Preclinical Data Showing Synergy of Combination of Sapacitabine with Histone Deacetylating Agents

BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Oct 21, 2008 - Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) announced today the presentation of a poster highlighting preclinical synergy of Cyclacel's sapacitabine when given in combination with histone deacetylating agents (HDAC) valproate and vorinostat. The data will be presented at the 20th Annual European Organization for Research and Treatment of Cancer-National Cancer Institute-American Academy of Cancer Research (EORTC-NCI-AACR) Symposium on "Molecular Targets and Cancer Therapeutics," which will be held October 21- 24, 2008 in Geneva, Switzerland.

The combinations of sapacitabine and HDAC inhibitors were evaluated in models of acute myeloid leukemia (AML) both in vivo and in vitro and in vitro in additional tumor types. In each setting the combinations had significantly enhanced anticancer activity when compared to single agent treatment.

Details of the poster presentation are as follows:

"The nucleoside analogue sapacitabine (CYC682) synergizes with histone deacetylase inhibitors in multiple tumor types"

Date/Time: Friday, October 24, 2008, 12:00 AM - 2:00 PM

Abstract Number: 470

The abstract is available online at http://www.ecco-org.eu.

About sapacitabine

Sapacitabine acts through a dual mechanism, interfering with DNA synthesis by causing single-strand DNA breaks and inducing arrest of cell cycle progression mainly at G2/M-Phase. Both sapacitabine and CNDAC, its major metabolite, have demonstrated potent anti-tumor activity in preclinical studies. Sapacitabine to date has been given as a single agent to approximately 170 patients with both hematologic malignancies and solid tumors in four Phase 1 studies. In an earlier reported Phase 1 trial two treatment schedules of sapacitabine were evaluated in 47 pretreated patients with advanced leukemias or MDS. Six patients achieved complete remission or complete remission without platelet count recovery and a further 15 achieved non-detectable levels of leukemic blast cells in their bone marrow. Sapacitabine is being studied in a Phase 2 study in elderly AML patients (enrollment completed) and MDS patients (ongoing) and in a Phase 2 study in patients with advanced cutaneous T cell lymphoma (ongoing).

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(R). 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(TM) Cream for radiation dermatitis, Numoisyn(TM) Liquid and Numoisyn(TM) 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(R) are trademarks of Cyclacel Pharmaceuticals, Inc.; Numoisyn(TM) and Xclair(TM) are trademarks of Sinclair Pharma plc; Tarceva(R) 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.

Contact

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

 

Posted: October 2008

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