Cyclacel is currently conducting a Phase 2b, multi-center, randomized, double-blinded clinical trial to evaluate the efficacy and safety of seliciclib (CYC202), an orally available molecule that targets specific Cyclin Dependent Kinases (CDKs). The APPRAISE study is evaluating seliciclib in patients with non-small cell lung cancer (NSCLC) who have failed at least two prior therapies. Seliciclib is also being evaluated in a Phase 2 study as a single agent in nasopharyngeal cancer (NPC).

Read more in the press release Cyclacel begins a Phase 2b randomized trial of seliciclib for previously treated non-small cell lung cancer and Cyclacel Pharmaceuticals provides year end 2007 pipeline update and outlines 2008 Key Business Objectives

Phase 2 clinical trial in patients with previously treated non-small cell lung cancer

Study Design:

The study is designed as a randomized discontinuation trial. The study will enroll approximately 200 patients who will receive seliciclib for at least three treatment cycles. Those patients who achieve stable disease will be randomized to continue the drug or receive placebo with best supportive care. Patients in the placebo group whose disease progresses will be given the option to receive the seliciclib treatment again.

Primary Endpoint:

• Progression free survival

Secondary Endpoints:

• Overall survival
• Response rate
• Response duration
• Safety
• Tolerability

Enrolment Criteria:

Learn more about enrolment criteria at:

http://www.clinicaltrials.gov/ct/show/NCT00372073?order=1.

Study Sites:

For more information, please visit:

http://www.clinicaltrials.gov/ct/show

Phase 2 clinical trial as a single agent with Nasopharyngeal Cancer (NPC)

Study Design:

The study is designed as an international, blinded randomized trial with two dosing schedules. The trial will enrol a total of approximately 75 patients.

Primary Endpoint:

• Evaluate six month progression-free survival (PFS) of two dosing schedules of seliciclib in patients with previously treated nasopharyngeal carcinoma.

Secondary Endpoints:

• Detect major differences between the two dosing schedules of seliciclib and a placebo group in terms of six month PFS