Cyclacel Reports Phase 2 Sapacitabine Data in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes At 2009 ASCO Annual Meeting

Friday, May 29, 2009 2:00 PM

   Emerging Sapacitabine Data Paving the Way for a Pivotal Trial to
                               Start in 2009
    Conference Call Scheduled for Wednesday, June 3rd At 4:30 ET

ORLANDO, Fla., May 29, 2009 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) today announced interim data from a Phase 2 randomized clinical trial of oral sapacitabine (CYC682), a novel nucleoside analog, in elderly patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) at the 45th annual meeting of the American Society of Clinical Oncology (ASCO) (Abstract 7021). The data demonstrated that oral sapacitabine is active in AML across all three dosing schedules tested and that prolonged administration is feasible in the outpatient setting. Activity was also observed in the ongoing MDS stratum of the study. Based on the data, Cyclacel intends to use the 3-day dosing schedule for further clinical development in elderly AML and will discuss with the FDA the design of a pivotal study in elderly patients with AML expected to commence in 2009.

"I am encouraged by these Phase 2 results, which demonstrate that oral sapacitabine produced durable clinical benefit in elderly patients with AML with low extramedullary toxicity," said Dr. Hagop Kantarjian, Professor of Medicine and Chairman of the Leukemia Department at The University of Texas M. D. Anderson Cancer Center and Principal Investigator of the trial. "AML in elderly patients is a challenging disease because elderly patients often experience increased induction mortality and toxicities from conventional chemotherapy because of advanced age and pre-existing comorbid conditions. Sapacitabine has the potential to be a safe and effective treatment for elderly patients with untreated or relapsed AML."

The 3-day dosing schedule demonstrated:

  --  overall response rate in AML of 35%, including complete
      remission (CR) of 25%,
  --  median treatment in patients with CR exceeding 9 cycles and
  --  all-cause 30-day mortality of 9.4%.

"We are pleased with the interim Phase 2 results, which support our decision to advance sapacitabine to a pivotal study in AML later this year," said Judy Chiao, M.D., Vice President, Clinical Development and Regulatory Affairs of Cyclacel. "We are grateful for the enthusiasm and contributions of our investigators, their colleagues and patients who helped us achieve this important milestone. We look forward to reporting one year survival data in AML from this Phase 2 study in the second half of 2009."

Phase 2 Study Details

The Phase 2 study rapidly enrolled during 2008 a total of 60 patients aged 70 years or above with untreated or first relapse AML and randomized them to one of three dosing schedules. In the 3-day dosing schedule, a response rate of 35% (7/20 patients) was observed of which 25% (5/20 patients) achieved CR. The median number of treatment cycles in responders currently exceeds nine (range of 3 to over 18 cycles) with 5 of 7 responders still on treatment.

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