Cyclacel reaches SPA agreement with FDA for sapacitabine Phase 3 trial in AML

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC), (Nasdaq:CYCCP), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a pivotal Phase 3 trial for the Company's sapacitabine oral capsules as a front-line treatment in elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy.

"The SPA agreement with FDA represents an important milestone for Cyclacel and provides a clear registration pathway for sapacitabine," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "If it reaches the market, sapacitabine would be the first orally-administered drug to be offered to this patient population with the potential to serve as induction, consolidation and maintenance treatment of this life-threatening disease. In addition to progressing to Phase 3 in AML, we look forward to reporting sapacitabine Phase 2 data in myelodysplastic syndromes (MDS) and non-small cell lung cancer (NSCLC)."

The Phase 3, registration-directed, clinical trial of sapacitabine oral capsules to be conducted under the SPA will be a randomized study against an active control drug with the primary objective of demonstrating an improvement in overall survival.   Sapacitabine will be administered as an outpatient treatment. Cyclacel plans to begin patient enrollment in this Phase 3 trial before the end of 2010. Additional information on the design of the trial will be provided after initiation of the study.

"We are pleased to receive the SPA Agreement letter from the FDA stating that the design and planned analysis of the pivotal Phase 3 study adequately address the objectives necessary to support the submission of a New Drug Application (NDA)," said Judy Chiao, M.D., Vice President of Clinical Development and Regulatory Affairs of Cyclacel. "AML in the elderly is a life-threatening disease with high unmet medical need.  Patients with AML aged 70 years or older have a poor prognosis as the majority of these patients are not candidates for intensive induction chemotherapy because of poor tolerability to such therapy and a high risk of relapse because of the lack of effective consolidation and maintenance therapy.  We will now concentrate our efforts on initiating the Phase 3 study in AML in collaboration with our clinical investigators."

In addition to the Cyclacel-sponsored trials of sapacitabine, the company has been approached by cooperative groups seeking to conduct, largely at their expense, investigator-initiated studies of sapacitabine with alternative study designs.