Beneficial Effects Of Seliciclib (CYC202) Reported In Models Of Kidney Disease

Dundee, UK - 8 November 2004 - Cyclacel Group plc (“Cyclacel”), the UK-based biopharmaceutical company, announced today preclinical data showing activity of its experimental CDK inhibitor drug seliciclib (CYC202 or R-roscovitine) in two models of kidney disease. The results were reported in last week’s American Society for Nephrology meeting by two independent Italian and British teams investigating seliciclib in lupus nephritis and crescentic glomerulonephritis.

Investigators from the Mario Negri Institute and Ospedali Riuniti, Bergamo, Italy, presented data showing that seliciclib significantly improved survival of animals with lupus nephritis and at the same time had a protective effect on kidney function. In one arm of the study where the drug was administered as preventive treatment early in disease progression, seliciclib decreased indicators of renal damage and significantly increased the life span of treated over untreated animals (p<0.01). In a second study in animals with established disease, seliciclib treatment in combination with a low dose of methylprednisolone, a drug commonly used to treat patients with this disease, markedly improved survival over untreated animals (p<0.0001), reduced proteinuria (p<0.01) and delayed the onset of renal damage compared with either treatment alone (p<0.01). The investigators further reported that in both the preventive and therapeutic studies seliciclib treatment reduced the levels of serum anti-DNA antibodies (p<0.01), a biomarker reflecting kidney disease activity.

Investigators from Hammersmith Hospital, London, presented data showing that seliciclib attenuated disease in a mouse model of crescentic glomerulonephritis, an autoimmune disease in which overgrowth of kidney cells caused by inflammation results in irreparable damage to the kidney. In these experiments seliciclib prevented cellular proliferation, crescent formation and renal impairment. Formation of crescents is a marker of overgrowth of kidney cells, leads to blockage of blood filtration and ultimately impaired renal function and kidney failure. The investigators demonstrated that seliciclib decreased crescent formation over controls (p<0.05) even when the disease was established prior to any treatment.

Spiro Rombotis, Chief Executive Officer of Cyclacel, said: “Independent investigators continue to validate our belief that CDK inhibitor drugs may be useful in diseases beyond cancer, although cancer remains our main focus. There is a pressing medical need to treat patients suffering from inflammatory kidney diseases and cell cycle inhibitors could make important contributions in this field.”

About Cyclacel ( www.cyclacel.com )
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. The company is currently evaluating seliciclib (CYC202), an orally-available cyclin dependent kinase inhibitor, in Phase II clinical trials for the treatment of non-small cell lung cancer and B-cell hematological malignancies. CYC682 is an orally-available, cell cycle modulating nucleoside analog in Phase I clinical trials for the treatment of cancer. Cyclacel also has seven programs in preclinical development.

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