Cyclacel Provides Corporate Update at OneMedForum Conference; Re-Analysis "Insufficient"

Cyclacel Pharmaceuticals, Inc. CYCC today summarized its 2011 achievements and set forth the Company's key business objectives for 2012 in a presentation given by Spiro Rombotis, President and Chief Executive Officer, at the 5th Annual OneMedForum Conference held this week in San Francisco, California. "During 2011, we continued to make important progress advancing the development of sapacitabine in both hematologic malignancies and solid tumors with multiple clinical studies currently in progress," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We are encouraged by the pace of patient enrollment and investigator interest in SEAMLESS, our pivotal Phase 3 trial of sapacitabine as a front-line treatment of acute myeloid leukemia (AML), which was initiated in 2011. For 2012, we are focused on executing our product development plan for sapacitabine with a target of having approximately fifty clinical trial sites open." Review of 2011 Accomplishments Sapacitabine Opened enrollment of the SEAMLESS pivotal Phase 3, randomized, registration-directed, trial for the Company's sapacitabine oral capsules as a front-line treatment of elderly patients aged 70 years or older with newly diagnosed AML who are not candidates for intensive induction chemotherapy. SEAMLESS is being conducted under a Special Protocol Assessment (SPA) agreement that Cyclacel reached with the U.S. Food and Drug Administration (FDA). SEAMLESS builds on promising response rate and overall survival (OS) observed in elderly patients aged 70 years or older with newly diagnosed AML or AML in first relapse enrolled in a Phase 2 study of single agent sapacitabine and a Phase 1/2 clinical study examining the safety and efficacy of sapacitabine administered sequentially with decitabine. Reported results at the 2011 American Society of Clinical Oncology meeting from a pilot study evaluating the same treatment regimen of sapacitabine dosed sequentially with decitabine, as used in the active arm of SEAMLESS. In the multicenter, pilot Phase 1/2 clinical trial examining the safety and effectiveness of oral sapacitabine administered sequentially with decitabine, 30-day mortality from all causes was 4.5% and 60-day mortality from all causes was 9.5%. The overall response rate (ORR) was 34.8%. Data from the lead-in portion of the SEAMLESS Phase 3 trial of sapacitabine in elderly patients with AML confirmed the safety and tolerability observed in the pilot Phase 1/2 study and met the criteria prespecified in the protocol to proceed to the randomized stage of the study. The independent Data Safety Monitoring Board (DSMB) of SEAMLESS recommended that the study should enter the randomized stage as planned. Reported updated results at the 2011 American Society of Hematology meeting, from the Phase 1/2 clinical trial evaluating the same treatment regimen of sapacitabine dosed sequentially with decitabine, as the active arm in SEAMLESS. The study enrolled 25 patients aged 70 years or older, 76% of which were aged 75 years or older. Thirty-day mortality from all causes was 4% and 60-day mortality from all causes was 12%. The ORR rate was 40%. Median OS is 231 days and 44% of patients are still alive. Presented preclinical results for sapacitabine at the 2011 American Association for Cancer Research meeting describing potential mechanism-based drug combinations. Together with previous publications these findings further support the rationale for clinical testing of sapacitabine with inhibitors of DNA repair in both solid tumors and hematological malignancies. Commenced an investigator-initiated, Phase 2 trial of sapacitabine in combination with cyclophosphamide and rituximab in patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and 11q22-23 deletion at The University of Texas MD Anderson Cancer Center. Deletion at chromosome 11q22-23 is associated with deletion of the Ataxia Telangiectasia Mutated (ATM) gene, an important element of the HRR pathway. Previous findings show that cells with HRR pathway defects are particularly sensitive to sapacitabine. Sapacitabine may therefore be of particular benefit to patients with ATM-defective blood cancers. Announced interim topline data from ongoing clinical studies with sapacitabine in heavily pretreated patients with advanced solid tumors, including Phase 2 single-agent data in non-small cell lung cancer (NSCLC) and Phase 1 data in combination with Cyclacel's seliciclib in breast, ovarian, pancreatic and other cancers. Partial responses (PR) and stable disease were observed in both studies. In the Phase 1 trial, responding patients were found to be carriers of BRCA mutations.