Healthcare Industry News:  non-small cell lung cancer 

Biopharmaceuticals Oncology FDA

 News Release - December 13, 2006

Cyclacel Submits IND of CYC116 an Aurora Kinase and VEGRF2 Inhibitor to Treat Cancer

SHORT HILLS, N.J.--(HSMN NewsFeed)--Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC, NASDAQ: CYCCP) announced today that it has submitted an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) to begin clinical trials of CYC116, the company's orally available inhibitor of Aurora kinases A & B and VEGFR2. CYC116 is the third targeted drug candidate from Cyclacel to enter clinical development for the treatment of cancer.

"CYC116 has a unique target profile involving both cell cycle and angiogenesis inhibition mechanisms. In preclinical studies, it demonstrated antitumor activity in both solid tumors and hematological cancers," said Spiro Rombotis, President and CEO of Cyclacel. "The development of CYC116, which emerged wholly from our internal discovery efforts, has capitalized on Cyclacel's strength in cancer biology. Advancement of this drug to IND submission marks another important milestone achieved by the Cyclacel team as part of our strategy of building a portfolio of drugs aimed at distinct targets in the cancer cell cycle."

Aurora kinases are a family of serine/threonine protein kinases that are crucial for ensuring the success of cell division, or mitosis. These proteins, which have been found to be over-expressed in many types of cancers, have generated significant scientific and commercial interest as cancer drug targets. The Aurora kinase family was discovered by Professor David Glover, Chief Scientist of Cyclacel's Polgen Division. VEGFR2 is a receptor protein that is part of the signaling pathways regulating angiogenesis or blood vessel formation. Several drugs that block angiogenesis have been approved for clinical use after showing efficacy in the treatment of colorectal, kidney and lung cancers.

Cyclacel has two additional compounds in development: seliciclib (CYC202) is being evaluated in a Phase IIb randomized double-blinded study as a third line treatment for patients with advanced non-small cell lung cancer (NSCLC) and sapacitabine (CYC682) is in Phase I clinical trials in solid and hematological cancers.

About Cyclacel Pharmaceuticals, Inc.

Cyclacel is a clinical-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 in Phase I clinical trials for the treatment of cancer. CYC116, an orally-available, Aurora kinase and VEGFR2 inhibitor is at the IND submission 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.

Source: Cyclacel Pharmaceuticals

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