Novel Drug Combination Active in Patients With Incurable BRCA-Deficient Cancers
WASHINGTON, April 8, 2013 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company") today announced that the American Association of Cancer Research (AACR) highlighted data at a press conference in Washington, D.C. from a clinical trial evaluating a novel combination regimen of two of the Company's orally available, experimental drugs, sapacitabine and seliciclib. The trial enrolled patients with an incurable form of cancer associated with BRCA defects in the patients' genome. The press conference was held yesterday on the occasion of the American Association of Cancer Research (AACR) Annual Meeting 2013 which opened here this weekend.
"We are pleased to have our data with sapacitabine and seliciclib selected by the AACR's Annual Meeting Program Committee," said Spiro Rombotis, Cyclacel's President and Chief Executive Officer. "Our novel, all-oral, combination of two Cyclacel drugs fits the theme of this year's AACR: 'Personalizing Cancer Care Through Discovery Science'. This recognition of the importance of our work attests to the quality of Cyclacel's scientists and pipeline. Together with our late-stage clinical trial of sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia, these promising data in patients with solid tumors suggest the emergence of a personalized medicine strategy for Cyclacel in an area of high unmet medical need."
The press conference highlighted a small number of data presentations selected from approximately 6,000 scientific presentations at the conference by investigators from around the globe. Among the selected data, AACR previewed promising results of the sapacitabine and seliciclib regimen. The regimen was used to treat patients with incurable BRCA-deficient cancers. There are no drugs yet approved specifically for this patient population.
At the press conference the principal investigator of the study, Geoffrey Shapiro, M.D., Director, Early Drug Development Center, Dana-Farber Cancer Institute and Associate Professor, Department of Medicine, Harvard Medical School, announced that when given sequentially, sapacitabine and seliciclib, worked together to induce durable partial responses and prolonged stable disease in patients who carry a BRCA mutation. The complete data will be formally presented by Dr. Shapiro during the scientific session of the AACR on Tuesday, April 9, at 2 pm Eastern.
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. 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 www.cyclacel.com for additional information.
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.
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