News Release

Cyclacel's Seliciclib to be Evaluated in Investigator-Initiated Clinical Study to Treat Rheumatoid Arthritis

Aug 12 2013

Cyclacel's Seliciclib to be Evaluated in Investigator-Initiated Clinical Study to Treat Rheumatoid Arthritis

BERKELEY HEIGHTS, N.J. and DUNDEE, UK, Aug. 12, 2013 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company), today announced that scientists at Newcastle University have been awarded £1 million (approximately $1.5 million) by the UK's Medical Research Council for a clinical trial to evaluate whether seliciclib, Cyclacel's oral cyclin dependent kinase (CDK) inhibitor currently in clinical development to treat certain cancers, can be repurposed to treat rheumatoid arthritis (RA) in patients who do not respond to existing treatments. Seliciclib may work for RA by targeting proliferating fibroblasts, a different type of approach than conventional RA therapies, and could therefore succeed where these treatments have failed.

"Repurposing of drugs is a powerful way of bridging the gap between early stage research and development of new treatments," said Professor John Isaacs, Director of the Institute of Cellular Medicine at Newcastle University and lead investigator. "Compared with traditional drug discovery approaches, this is a considerably quicker route to the clinic because it leapfrogs the early stages of drug development. If our trial with seliciclib proves successful, it could dramatically improve treatment outcomes for patients with rheumatoid arthritis."

Over the past 20 years, improved treatment strategies and better drugs have resulted in greatly improved outcomes for patients. Currently available drugs for RA, called disease-modifying antirheumatic drugs (DMARDs), slow or halt the progress of the disease by reducing joint inflammation or neutralizing immune cells. However, many patients still do not recover and about one in ten do not respond at all to conventional treatments.

Scientists believe that another type of cell, fibroblasts, may be responsible and may be limiting response to conventional treatments. In RA these cells divide uncontrollably and produce chemicals that eat into cartilage and bone and cause inflammation.

Using Seliciclib to Target Fibroblasts

The Newcastle team, with collaborators at the Universities of Birmingham and Glasgow, believe that seliciclib may reduce or stop abnormal fibroblast activity. Seliciclib has been previously shown to selectively inhibit enzyme targets which are central to the process of cell division and cell cycle control thereby inhibiting cellular proliferation.

Seliciclib, an orally-available CDK2, -7 and -9 inhibitor, has been evaluated to date in approximately 380 patients and is currently being explored in combination with Cyclacel's orally-available sapacitabine in patients with solid tumors.

The researchers hope to show that seliciclib is safe and potentially effective in patients with RA. The trail design, to be finalised with the funding sponsor, will be a Phase 2 study treating patients who have had the condition for at least a year and who are already taking treatment but not responding well enough. If this is successful the study will continue to test seliciclib in patients taking different treatments, at different stages of their illness.

About Rheumatoid Arthritis (RA)

RA is a condition in which the joints become inflamed and painful. It is caused by the patient's immune system mistakenly attacking their joints. The resulting inflammation reduces joint movement and eventually causes joint damage and deformity. According to various estimates RA affects approximately 1.3 million adults in the US and 400,000 in the UK.

About Cyclacel Pharmaceuticals, Inc.

Cyclacel is a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases. Sapacitabine, Cyclacel's most advanced product candidate, is the subject of SEAMLESS, a Phase 3 trial being conducted under an SPA with the FDA as front-line treatment for acute myeloid leukemia (AML) in the elderly, and other studies for myelodysplastic syndromes (MDS), chronic lymphocytic leukemia (CLL) and solid tumors including breast, lung, ovarian and pancreatic cancer and in particular those carrying BRCA mutations. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a development pipeline of novel drug candidates. Please visit for additional information.

Forward-looking Statements

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, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, 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. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's most recent Annual Report on Form 10-K and other periodic and other filings Cyclacel files with the Securities and Exchange Commission and are available at Such forward-looking statements are current only as of the date they are made, and Cyclacel assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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CONTACT: Cyclacel Pharmaceuticals, Inc.
         Paul McBarron
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