Cyclacel is currently conducting Phase 2 clinical trials of sapacitabine (CYC682), an orally available nucleoside analog in patients with advanced cutaneous T-cell lymphoma and in elderly patients with acute myeloid leukaemia. A Phase 1 clinical trial in patients with advanced leukemias or myelodysplastic syndromes (MDS) is ongoing.

Read more in the press releases Cyclacel Pharmaceuticals begins Phase 2 study of oral sapacitabine in patients with advanced cutaneous T-cell lymphoma and Cyclacel initates Phase 2 sapacitabine trial in elderly AML patients and Cyclacel reports updated Phase 1 sapacitabine data at 2007 ASH meeting

Phase II clinical trial in patients with advanced cutaneous T-cell lymphoma

Study Design:

This is an open label, randomized Phase 2 study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL) who have had progressive, recurrent, or persistent disease on or following 2 systemic therapies.

Primary Endpoint:

• Response rate in overall skin disease

Enrolment Criteria:

Learn more about enrolment criteria at: www.clinicaltrials.gov.

Study Sites:

For more information, please visit: www.clinicaltrials.gov.

Phase 2 clinical trial in elderly patients with acute myeloid leukemia

Study Design:

This is a randomized phase 2 dose escalation study. The trial will enrol a total of approximately 60 patients or approximately 20 patients in each arm. The study uses a Bayesian continuous monitoring rule to stop accrual in one or more arms of the study in the event that a dosing schedule does not appear to have a sufficient number of responses.

Primary Endpoint:

• 1-year survival rate

Secondary Endpoints:

• To assess the number of patients who have achieved a CR or CR without blood count recovery (CRi), duration of CR or CRi, transfusion requirements, number of hospitalized days and safety

Enrolment Criteria:

Learn more about enrolment criteria at: www.clinicaltrials.gov.

Study Sites:

For more information, please visit: www.clinicaltrials.gov.

Phase 1 clinical trial in patients with advanced leukemias or myelodysplastic syndromes (MDS) Cyclacel reports updated Phase 1 sapacitabine data at 2007 ASH meeting

Study Design:

This study is designed as an open label, non-randomized, dose escalation trial. The study will involve approximately 20-30 patients who will receive sapacitabine every 12 hours for seven days, followed by 14 days of rest, to determine the maximum tolerated dose.

Primary Endpoint:

• Maximum tolerated dose

Secondary Endpoints:

• Pharmacodynamic effects of sapacitabine in tumor cells
• Relationship between pharmacokinetics and pharmacodynamics
• Correlation of the pharmacodynamic effects of sapacitabine with anti-cancer activity

Enrolment Criteria:

Learn more about enrolment criteria at: www.clinicaltrials.gov.

Study Sites:

For more information, please visit: www.clinicaltrials.gov.