Interim Lead-In Stage Data Show Seliciclib is Active in NPC in Both Schedules Tested

ORLANDO, Fla., May 29, 2009 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) today announced interim data from the lead-in stage of a Phase 2 randomized clinical trial of oral seliciclib (CYC202), a novel cyclin dependent kinase (CDK) inhibitor, in patients with solid tumors and previously-treated nasopharyngeal carcinoma (NPC) at the 45th annual meeting of the American Society of Clinical Oncology (ASCO) (Abstract 6026). The data demonstrated that oral seliciclib could be safely administered in two dosing schedules which were well tolerated and met the criteria for proceeding to the randomized stage of the study. Seliciclib treatment resulted in prolonged stable disease in previously-treated NPC patients suggesting seliciclib inhibits tumor growth in NPC. The data supports further clinical development of oral seliciclib in NPC.

"We are pleased with these results, which met the conditions specified in the study protocol for proceeding to the next stage," said Judy Chiao, M.D., Vice President, Clinical Development and Regulatory Affairs of Cyclacel. "We are grateful for the contributions of our investigators, their colleagues and patients who helped us complete the lead-in stage of this study. Although NPC is considered sensitive to radiation and chemotherapy treatments, once the disease recurs after initial chemotherapy and/or radiotherapy, the prognosis is poor despite the use of salvage chemotherapies. An unmet medical need exists for patients with recurrent and/or metastatic NPC. The results suggest that seliciclib induces prolonged stable disease and inhibits tumor growth in such patients and should be evaluated in randomized studies as a single agent and in combinations with other anti-cancer agents."

Best response by investigator assessment was:

 -- 7 out of 10 NPC patients achieved stable disease (SD) including
    3 with SD lasting longer than 8 months;
 -- 4 patients with other cancers (malignant histiocytoma, non-small
    cell lung, ovarian leiomyosarcoma and renal carcinomas) also
    achieved SD.

Phase 2 Study Details

Twenty-three patients were randomized to one of two dosing schedules of seliciclib (400 mg twice a day and 800 mg once a day both for 4 consecutive days every week for 3 weekly cycles), of which 13 had solid tumors and 10 previously-treated NPC. Twenty-one patients have received prior systemic therapies including 7 who had four or more prior systemic therapies.

The data demonstrated that seliciclib could be safely administered by the oral route on two dosing schedules both for 4 days per week. Both dosing schedules were well tolerated and met the criteria for proceeding to the randomized stage of the study.