Investors

BERKELEY HEIGHTS, N.J., May 14, 2012 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company") announced today completion of enrollment of the Phase 2 portion of the investigator-initiated, Phase 2/3 multicenter, randomized trial comparing sapacitabine to low dose cytarabine (the "Pick a Winner Programme / LI-1 Trial") in patients aged 60 years or older with previously untreated acute myeloid leukemia (AML) or high risk myelodysplastic syndromes (MDS) who are unfit for intensive chemotherapy. The study is being conducted by the U.K.'s Leukaemia Lymphoma Research and U.K. National Cancer Research Institute (NCRI) Working Group.¹ The study has reached the accrual goal of approximately 100 patients. More than 40% of patients are still alive and longer follow-up is needed to assess overall survival.

"We are pleased to have completed enrollment of the Phase 2 portion of sapacitabine vs. low-dose cytarabine in elderly patients with AML or high risk MDS," said Professor Alan K. Burnett, MD, Department of Haematology, University of Cardiff and study chair.  "No safety concerns were identified to date by the study monitoring Data Monitoring & Ethics Committee (DMEC). We expect the survival data to mature in the next few months at which point the DMEC will make a recommendation whether sapacitabine should enter Phase 3 development. Sapacitabine's oral route of administration and good tolerability offer significant advantages to elderly patients."

The "Pick a Winner Programme / LI-1" Trial

The "Pick a Winner Programme / LI-1" Trial is an investigator-initiated, Phase 2/3 multicenter, randomized interventional study evaluating whether standard of care treatment for AML or high-risk MDS patients may be improved upon either in combination with novel agents or by use of novel agents alone. The study is being conducted by the U.K.'s Leukaemia Lymphoma Research and U.K. National Cancer Research Institute (NCRI) Working Group and is evaluating among others sapacitabine in comparison to low dose cytarabine in approximately 100 patients aged 60 years or older with previously untreated AML or high risk MDS who are unfit for intensive chemotherapy. If in the Phase 2 portion of the study the sapacitabine arm appears to be sufficiently promising, the DMEC will recommend that sapacitabine proceeds to Phase 3 development. 

About Acute Myeloid Leukemia (AML)

AML is a cancer of the blood cells that progresses rapidly and if not treated, could be fatal in a few months. AML is generally a disease of older people and is uncommon before the age of 40. The average age of a patient with AML is about 67 years. There are more than 12,300 new cases of AML, of which about half are elderly, and nearly 9,000 deaths are caused by this cancer each year in the United States. A recently published review of The University of Texas MD Anderson Cancer Center's historical experience with front-line intensive induction chemotherapy for AML patients aged 70 years or older, excluding patients with favorable karyotypes, demonstrated that while 45% achieved a complete remission, median overall survival was only 4.6 months and was associated with a 4-week death rate of 26% and an 8-week death rate of 36% (Kantarjian, H, et al, Blood, DOI 10.1182/blood-2010-03-276485).

Currently no single approach can be considered the standard of care for elderly AML patients unfit for intensive chemotherapy. Low dose cytarabine has been associated with an increased remission (CR) rate and a small survival benefit over best supportive care of hydroxyurea. As part of the U.K. National Cancer Research Institute AML 14 trial, 217 patients deemed unfit for intensive chemotherapy were randomized to either low dose cytarabine or hydroxyurea. Thirty day mortality was 26% on both arms, mainly due to disease progression. Low dose cytarabine produced a better remission rate (18% vs 1%) and a better overall survival, however there was no CR benefit in patients with adverse cytogenetics. (Burnett AK, et al, Cancer, 2007:109:1114-1124).

About MDS

MDS is a family of clonal myeloid neoplasms, or malignancies of the blood, caused by the failure of blood cells in the bone marrow to develop into mature cells.  Patients with MDS typically suffer from bone marrow failure and cytopenias, or reduced counts of platelets, red and white blood cells. The exact incidence and prevalence of MDS are unknown because it can go undiagnosed and a national survey has not been completed.  Some estimates place MDS incidence at 15,000 to 20,000 new cases each year in the US alone with some authors estimating incidence as high as 46,000.  Literature evidence suggests that there is a rising incidence of MDS as the age of the population increases with the majority of patients aged above 60 years.

Most patients with high risk disease, as defined by IPSS, die from their disease within one year of diagnosis with reported mean survival rates of six to nine months.  Patients with high IPSS scores, such as intermediate-2 and high risk, have a high probability of experiencing transformation of their MDS into AML, an aggressive form of blood cancer with typically poor survival.

About sapacitabine

Sapacitabine (CYC682), an orally-available nucleoside analogue, is currently being evaluated in SEAMLESS, a registration-directed, Phase 3 trial in elderly patients with newly diagnosed acute myeloid leukemia (AML), Phase 2 trials in patients with hematological malignancies, including myelodysplastic syndromes (MDS), cutaneous T-cell lymphoma (CTCL), chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), and non-small cell lung cancer (NSCLC) and in a Phase 1 trial in combination with seliciclib in patients with advanced solid tumors. Sapacitabine acts through a novel DNA single-strand breaking mechanism, leading to production of DNA double strand breaks (DSBs) and/or checkpoint activation. Unrepaired DSBs cause cell death. Repair of sapacitabine-induced DSBs is dependent on the homologous recombination DNA repair (HRR) pathway. Both sapacitabine and CNDAC, its major metabolite, have demonstrated potent anti-tumor activity in preclinical studies.

Over 350 patients have received sapacitabine in Phase 2 studies in AML, MDS, CTCL and NSCLC. Sapacitabine has been administered to approximately 170 patients in five Phase 1 studies with both hematological malignancies and solid tumors. In June 2009 at the Annual Meeting of the American Society of Hematology (ASH), Cyclacel reported data from a randomized Phase 2, single-agent study of sapacitabine including promising 1-year survival in elderly patients with AML aged 70 years or older. In June 2011 at the Annual Meeting of the American Society of Clinical Oncology (ASCO), Cyclacel reported data from a pilot Phase 1/2 study including promising response rate, low 4-week and 8-week mortality in elderly patients with AML aged 70 years or older receiving sapacitabine alternating with decitabine. The FDA and the European Medicines Agency have designated sapacitabine as an orphan drug for the treatment of both AML and MDS. Sapacitabine is part of Cyclacel's pipeline of small molecule drugs designed to target and stop uncontrolled cell division.

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 (CYC682), an orally-available, cell cycle modulating, nucleoside analogue, is in the SEAMLESS Phase 3 trial being conducted under an SPA with the FDA for the front-line treatment of AML in the elderly and Phase 2 studies for myelodysplastic syndromes, lung cancer and chronic lymphocytic leukemia. Seliciclib (CYC202 or R-roscovitine), an orally-available, CDK (cyclin dependent kinase) inhibitor, is in Phase 2 studies for the treatment of lung cancer and nasopharyngeal cancer and in a Phase 1 trial in combination with sapacitabine. Cyclacel's ALIGN Pharmaceuticals subsidiary markets directly in the U.S. Xclair® Cream for radiation dermatitis, Numoisyn® Liquid and Numoisyn® Lozenges for xerostomia. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a portfolio of commercial products and a development pipeline of novel drug candidates. Please visit www.cyclacel.com 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 our most recent Annual Report on Form 10-K and other periodic and other filings we file with the Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

© Copyright 2012 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc. Numoisyn® and Xclair® are trademarks of Sinclair Pharma plc.

¹ For more information please refer to: http://www.controlled-trials.com/ISRCTN40571019.

CONTACT: Contact for Cyclacel Pharmaceuticals, Inc.

         Investors/Media: Corey Sohmer, (908) 517-7330, 

         csohmer@cyclacel.com