Home Investors News Press Releases 2002 Cyclacel Announces Clinical Trials Of Lead Drug CYC202 In Inflammatory Kidney Disease

Cyclacel Announces Clinical Trials Of Lead Drug CYC202 In Inflammatory Kidney Disease

ZURICH -15 May 2002 - Cyclacel Limited, the UK-based biopharmaceutical company, announced today its plans to investigate in clinical trials the potential use of its lead drug, CYC202, in the treatment of glomerulonephritis (GN), a group of inflammatory diseases of the kidney. The announcement was made by Spiro Rombotis, CEO, in a Cyclacel presentation to investors and the media during the BioEquity Europe 2002 Investment Conference. Glomerulonephritis is a major cause of kidney failure or End-Stage Renal Disease (ESRD), the treatment of which requires dialysis or kidney transplantation. Approximately $17 billion is spent annually to treat ESRD in the USA alone, one of few medical conditions to have received dedicated funding by act of Congress.

Cyclacel has already completed a Phase I study of CYC202 in healthy volunteers and several preclinical studies in models of GN in preparation for advanced clinical trials in GN patients expected to start in the autumn of 2002. The Phase I trial in volunteers provided additional evidence that CYC202 is safe and well tolerated consistent with previously announced Phase Ia results in cancer patients. The preclinical data suggest that CYC202 causes cellular responses and improvement of kidney function in multiple disease models of GN.

CYC202 is currently in multicentre Phase Ib clinical trials in patients with cancer to determine the safety, maximum tolerated dose and pharmacokinetic profile of the product. Phase Ia studies in cancer patients showed CYC202 to be well tolerated and orally available.

Dr Robert Jackson, Executive Director, Research and Development at Cyclacel said: "CYC202 is a molecule that acts on the cell cycle, the process by which cells divide and grow. As in cancer, certain kidney diseases are characterised by abnormal cell proliferation and we are now exploring the potential of CYC202 in treating these conditions. Our work is still at an early stage but the evidence so far is promising and supports our belief that cyclin dependent kinase (CDK) inhibitors such as CYC202 have potential outside cancer."

Spiro Rombotis, Cyclacel's Chief Executive, said: "Our data suggesting that CYC202 may be useful in GN illustrates how Cyclacel's understanding of cell cycle biology can lead to expanded commercial opportunities from our core scientific and technical competence. By efficiently expanding our business into further therapeutic areas where our existing drugs show promise, we can leverage shareholder returns whilst at the same time reducing overall enterprise risk. We expect that our genes-to-drugs approach and integrated rational drug design capabilities ranging from genomic targets to clinical trials will allow us to take advantage of further such business opportunities in the future."

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