Cyclacel Initiates Patient Enrollment In Third Phase I Clinical Trial Of CYC682

Dundee, U.K. - 7 September 2004 - Cyclacel Group plc (“Cyclacel”), the cell cycle-based biopharmaceutical company, announced today that it has commenced patient enrollment in a third Phase I trial of CYC682, a novel anticancer drug acting on the cell cycle. CYC682, an orally available small molecule nucleoside analog drug, is Cyclacel’s second candidate to enter clinical trials.

The new trial is an open-label, Phase Ib study testing CYC682 in patients with solid tumors or lymphoma. The primary objective of the study is to evaluate the safety profile of escalating doses of CYC682. Treatment will be given in cycles of 14 days every three weeks until evidence of disease progression. Secondary objectives are to analyze the pharmacokinetics of CYC682 and its metabolite together with investigating the use of biomarkers to predict tumor sensitivity. Assessment of CYC682 objective tumor response will also be reported. The study is taking place at two clinical centers in the United States. Results are expected in the second quarter of 2005.

CYC682 has been the subject of two Phase I studies in the United States to explore safety and pharmacokinetics. These trials involved a total of 87 patients with a variety of cancers, who were dosed by mouth either three or five days per week for four weeks of each six week cycle.

About Cyclacel
Cyclacel is a biopharmaceutical company dedicated to the discovery, development and commercialization of novel, mechanism-targeted drugs to treat human cancers and other serious disorders. CYC682 is one of two clinical stage, cell cycle modulating compounds at Cyclacel. The company is currently evaluating CYC202, a cyclin dependent kinase inhibitor, in Phase II clinical trials for the treatment of non-small cell lung cancer and B cell hematological malignancies. Cyclacel also has seven programs in preclinical development.