- SEAMLESS DSMB recommended that the study should continue as planned -
- Company to Present at the Biotech Showcase™ 2013 Conference on Monday January 7, 2013 at 3:15 pm PT -
BERKELEY HEIGHTS, N.J., Jan. 7, 2013 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company) today reviewed 2012 achievements and provided an outline of the Company's key clinical development objectives for 2013, which will be highlighted at the Company's presentation during the Biotech Showcase™ 2013 Conference at 3:15 pm Pacific Time on Monday, January 7, 2013, at the Parc 55 Wyndham Hotel in San Francisco, CA.
"During 2012, we advanced the clinical development of sapacitabine in multiple indications. For example, in our SEAMLESS, Phase 3, registration-directed study, of sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (AML), our lead indication, we exceeded 100 patients enrolled with 37 trial sites open," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "In addition, the independent committee overseeing SEAMLESS recently recommended that the study should continue as planned and identified no safety or efficacy concerns. We are encouraged by the continued investigator interest in SEAMLESS and plan to open additional sites during 2013. Updated survival data in AML with sequential administration of sapacitabine and decitabine is promising and provided further support for the SEAMLESS Phase 3 study. With regard to other disease indications, recent Phase 2 data demonstrated that sapacitabine nearly doubled expected survival of elderly patients with myelodysplastic syndromes (MDS) after treatment failure of hypomethylating agents. For 2013, we are focused on executing our product development plan for sapacitabine in AML, MDS and other cancers using, among other funds, the proceeds of the recent funding agreement with Aspire Capital. We are also advancing CYC065, our second-generation cyclin dependent kinase (CDK) inhibitor, enabled by a $1.9 million grant from the UK Government."
2012 Milestones and Accomplishments
2013 Key Upcoming Business Objectives
For the live and archived webcast of the Company's presentation at the Biotech Showcase™ 2013 San Francisco conference, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.
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. The Company's most advanced oral product candidate, sapacitabine, is the subject of SEAMLESS, a Phase 3 trial being conducted under an SPA with the FDA as front-line treatment of acute myeloid leukemia (AML) in the elderly and Phase 2 studies for AML, myelodysplastic syndromes (MDS), chronic lymphocytic leukemia (CLL) and solid tumors including breast, lung, ovarian and pancreatic cancer. Cyclacel's pipeline includes seliciclib, a CDK inhibitor, in Phase 2 for lung and nasopharyngeal cancer and in Phase 1 in combination with sapacitabine; and CYC065, a second generation CDK inhibitor, in IND-directed development. 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.
© Copyright 2013 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. Vidaza® is a registered trademark of Celgene Corporation. Dacogen® is a registered trademark used by Eisai Inc. under license from Astex Pharmaceuticals, Inc.
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