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News Release

Cyclacel announces development plan for its seliciclib CDK inhibitor to treat nasopharyngeal cancer

Feb 05 2007

Cyclacel announces development plan for its seliciclib CDK inhibitor to treat nasopharyngeal cancer

BERKELEY HEIGHTS, NJ, February 5, 2007 – Cyclacel Pharmaceuticals, Inc. ("Cyclacel", the "Company") (Nasdaq: CYCC) (Nasdaq: CYCCP) announced today that it intends to commence in the second half of 2007 clinical development of seliciclib, the company’s orally available cyclin dependent kinase (CDK) inhibitor, as a treatment for patients with nasopharyngeal cancer (NPC). Seliciclib is Cyclacel’s most advanced targeted drug candidate and is currently in Phase IIb development as a third line treatment for patients with advanced non-small cell lung cancer (NSCLC).

"Our decision to pursue NPC is based on a strong biological rationale, clinical data from an independent investigator-sponsored study and a global survey of NPC treatment centers that identified an important need for improving therapy for this disease," said Spiro Rombotis, President and CEO of Cyclacel. "NPC is a rare cancer in Western countries but is endemic in some areas of Asia and the Mediterranean region. Expanding potential indications of seliciclib is part of our strategy to develop novel drugs based on the understanding of cell cycle biology in cancer."

NPC is a cancer of the nose and pharynx that has been linked to Epstein-Barr Virus (EBV) infection, environmental factors and genetic predisposition. Cell cycle dysregulation is often found in NPC and is characterized by the inactivation or underexpression of CDK inhibitors, such as p16 and p27, or overexpression of cyclin D1, leading to uncontrolled cell proliferation. The loss of p16 and p27 in patients with NPC has been reported to correlate with poor prognosis and local recurrence. Seliciclib inhibits CDKs 2/A, 2/E, 7 and 9. As its CDK effects mimic the biological effects of tumor suppressor genes, seliciclib may stop or slow down the uncontrolled cellular proliferation of NPC.

In a small Phase I investigator-sponsored study designed to study the pharmacodynamic effects of seliciclib, clinical antitumor activity was observed in seven out of thirteen locally advanced, treatment naïve NPC patients at a dose that was well tolerated. The clinical effect was correlated in some patients with a reduction in EBV viral copy number in the serum indicating a decrease in disease burden. The investigators reported that seliciclib treatment was accompanied by increased apoptosis or programmed death of cancer cells, depletion of the MCL-1 anti-apoptotic protein, evidence of tumor necrosis in biopsy tumor samples and that these findings suggested an increase in tumor cell death.

"In view of the biological rationale and clinical antitumor activity, we plan to conduct further clinical investigation to assess the safety and efficacy of seliciclib in advanced NPC. Although NPC is considered sensitive to radiation and chemotherapy treatments, once the disease recurs after initial chemotherapy and/or radiotherapy, the prognosis is poor despite the use of salvage chemotherapies" commented Dr. Judy Chiao, Vice President of Clinical Development and Regulatory Affairs of Cyclacel.

Cyclacel has two additional compounds in development: sapacitabine (CYC682) is in Phase I clinical trials in solid and hematological cancers and CYC116, an Aurora kinase and VEGFR2 inhibitor, for which an IND was recently submitted.

About NPC

NPC is a cancer of the nose and pharynx. Although NPC is often classified as a tumor of the head and neck its etiology is different than head and neck cancer and is linked to Epstein-Barr Virus (EBV) infection, environmental factors and genetic predisposition. There are no approved medicines to treat NPC and upon relapse the disease is ultimately fatal. It is estimated that there are approximately 85,000 new cases of NPC globally of which 2,300 in the United States, 2,000 in the European Union and 42,000 in Pacific Rim countries and in particular China, Hong Kong and Singapore.

About Cyclacel Pharmaceuticals, Inc.

Cyclacel is a development-stage biopharmaceutical company dedicated to the discovery, development and commercialization of novel, mechanism-targeted drugs to treat human cancers and other serious disorders. The Company is currently evaluating seliciclib (CYC202), an orally-available cyclin dependent kinase inhibitor, in Phase IIb clinical trials for the treatment of lung cancer. Sapacitabine (CYC682) is an orally-available, cell cycle modulating nucleoside analog is in Phase I clinical trials for the treatment of cancer. CYC116, an orally-available, Aurora kinase and VEGFR2 inhibitor is at the IND stage. Several additional programs are at an earlier stage.

Note: The Cyclacel logo and Cyclacel® are trademarks of Cyclacel 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 registration statement on Forms S-3 (File No. 333-134945) and S-4 (File No. 333-131225) and in the other reports of Cyclacel filed with the SEC.

Contacts for Cyclacel:

For Investors:
TS Communications Group, LLC (914) 921-5900
Tara Spiess / Andrea Romstad
For Media:
Feinstein Kean Healthcare (617) 577-8110
Robert Gottlieb / Kate Weiss