Results from Phase 2 trial of Sapacitabine expected on January 31 (Nasdaq:CYCC)

Sapacitabine is a drug that is being developed by Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC or Nasdaq: CYCCP), a biopharmaceutical company that discovers, develops and then commercialized drugs for cancers and other life-threatening diseases. The drug aims to treat aged patients – who are at least 70 years old and who are suffering from acute myeloid leukemia (AML), which is also called acute myelogenous leukemia. This is the most common type of acute leukemia that affects adults. As adults age, their likelihood of developing this disease increases. AML is basically a cancer that affects the myeloid blood cells. In this type of cancer, abnormal white blood cells grow rapidly and then get collected in the bone marrow, where they prevent the creation and the growth of normal blood cells. The drug sapacitabine is mainly for aged patients whose AML has been recently diagnosed and is in first relapse. On October 28, 2009, Cyclacel Pharmaceuticals disclosed that it has received information on the “topline survival data for the primary endpoint” from the Phase 2 trial that the company is conducting on sapacitabine. More detailed results of this trial are expected to be collected by January 31, 2010.

@@CalendarRight@@ The Phase 2 trial was a “three-arm randomized trial” that measured the effectiveness and the safety of three types of routines of doses of sapacitabine. The company confirmed that the primary endpoint for a survival period of one year has been 30 per cent for two out of the three routine types. So far the results from the Phase 2 trial had been favorable for Cyclacel Pharmaceuticals, though the company disclosed that the survival rate of the patients treated with sapacitabine is much lower than expected.

Spiro Rombotis, who is the Chief Executive Officer and also the President of Cyclacel Pharmaceuticals Inc., said:

“We are pleased to report such encouraging survival data from our Phase 2 study.  The data provide a strong rationale supporting the continued development of this novel agent with a differentiated mechanism of action. We are currently working with the FDA to design a Phase 3 registration study for sapacitabine in patients with hematological malignancies. We are concentrating our efforts on advancing sapacitabine into late stage development. In addition we are exploring its potential in solid tumors both as a single agent and in combinations.  If Phase 3 trials are successful, sapacitabine could emerge as the first oral drug for the treatment of AML and MDS.”