Interim data from Phase 2 clinical trial of sapacitabine in patients with MDS to be presented at ASCO 2010

May 21 2010

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) announced that new interim data from an ongoing, multicenter, Phase 2 clinical trial of oral sapacitabine, the Company's lead product candidate, will be presented at an oral poster discussion during the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois on Monday, June 7, 2010.

The Phase 2 study is evaluating sapacitabine administered as a single agent in older patients with myelodysplastic syndromes, or MDS, after treatment with hypomethylating agents.  

Oral poster discussion details are as follows:

"A randomized phase 2 study of sapacitabine in MDS refractory to hypomethylating agents"
Date/Time: Monday, June 7, 2010, 2:00 P.M. - 6:00 P.M. Eastern Time
Abstract Number: 6528
Location: E450a

Discussion time: 5:00 P.M. - 6:00 P.M. Eastern Time
Location: E354a

Sapacitabine Phase 2 study in MDS

The MDS study is designed as a protocol amendment expanding the fully enrolled Phase 2 trial of sapacitabine in acute myeloid leukemia, or AML, to include a stratum of patients with MDS refractory to hypomethylating agents. Patients with MDS often progress to AML. The primary objective of the MDS stratum is to evaluate the 1-year survival rate of three dosing schedules of sapacitabine. Secondary objectives are to assess the number of patients who have achieved CR or CRp, PR, hematological improvement and their corresponding durations, transfusion requirements, number of hospitalization days and safety. The MDS study uses a selection design with the objective of identifying a dosing schedule which produces a better 1-year survival rate in the event that all three dosing schedules are active.