Investors

News Release

Cyclacel Pharmaceuticals initiates Phase I study of CYC116 in patients with advanced solid tumors

Jun 29 2007

BERKELEY HEIGHTS, NJ, June 29, 2007 –– Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP) announced today that the company has begun a multicenter Phase I pharmacologic clinical trial of CYC116, an orally-available inhibitor of Aurora kinases A and B, and VEGFR2, in patients with advanced solid tumors. The study will be conducted by Nithya Ramnath, M.D., Alex A. Adjei, M.D. and colleagues at Roswell Park Cancer Institute in Buffalo, New York, and Anthony Tolcher, M.D. and colleagues at South Texas Accelerated Research Therapeutics (START) in San Antonio, Texas. The study is the first of two clinical trials the company plans to begin this year to evaluate CYC116’s potential in solid and hematological tumors.

The multicenter Phase I trial is designed to examine the safety and tolerability of CYC116 in patients with advanced solid tumors. The primary objective of the study is to determine the maximum tolerated dose. Secondary objectives are to evaluate the pharmacokinetic and pharmacodynamic effects of the drug and to document anti-tumor activity.

“CYC116 is a novel anticancer compound with a unique target profile involving both cell cycle and angiogenesis inhibition mechanisms. In preclinical studies, CYC116 has demonstrated antitumor activity in both solid tumors and hematological cancers”, said Judy Chiao, Vice President of Clinical Development and Regulatory Affairs of Cyclacel.

“This study marks the entry of our third drug candidate into clinical development,” said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. “The CYC116 program is part of our strategy to develop a portfolio of drugs that affect the cell cycle. Cyclacel’s other development-stage programs include sapacitabine, an orally available nucleoside analog, in Phase II clinical trials for patients with advanced cutaneous T-cell lymphoma and in Phase I for patients with advanced leukemias or myelodysplastic syndromes and seliciclib, an orally-available CDK (cyclin dependent kinase) inhibitor, in a Phase IIb clinical trial for non-small cell lung cancer.”

CYC116 was discovered in-house through Cyclacel’s cancer drug discovery program. The research effort was led by Cyclacel’s Chief Scientist, Professor David Glover, a world leader in the biology of mitosis and the discoverer of the Aurora kinase gene family.

About Aurora kinases and VEGFR2

Aurora kinases are a family of serine/threonine protein kinases that are critical to mitosis, the process of cell division. Aurora kinases are important for the progression through the M-phase of the cell cycle and are known to be over-expressed in a number of tumor types, including breast, colon, pancreas and bladder. Over-expression of Aurora kinases have been correlated with poor prognosis in these diseases.

VEGFR2 is a receptor protein that is part of the signaling pathways regulating angiogenesis, or blood vessel formation. Several drugs that block angiogenesis, including VEGFR2 inhibitors, have been approved for clinical use after showing safety and efficacy in the treatment of breast, colorectal, kidney and lung cancers.

CYC116 is the only targeted drug in clinical trials in patients with cancer that combines both anti-mitotic and anti-angiogenesis mechanisms.

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 Cyclacel drugs are in clinical development: sapacitabine (CYC682), an orally-available, cell cycle modulating nucleoside analog, in Phase II trials for the treatment of cutaneous T-cell lymphoma (CTCL) and in Phase I trials in patients with hematologic malignancies; seliciclib (CYC202), an orally-available CDK (cyclin dependent kinase) inhibitor, in Phase II trials for the treatment of lung cancer and CYC116, an orally-available, Aurora kinase and VEGFR2 inhibitor, in a Phase I trial in patients with advanced solid tumors. Several additional programs are at an earlier stage.

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.

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 Form 10-K (File No. 333-131225) and in the other reports of Cyclacel filed with the SEC.

Contacts for Cyclacel:

For Investors:
TS Communications Group, LL
(914) 921-5900
Tara Spiess

For Media:
Feinstein Kean Healthcare
(617) 577-8110
Heather McDonald
Robert Gottlieb