Cyclacel Begins CYC202 Phase I Trial

February 2001 - Limited, the UK-based cancer therapeutics company, today announced that CYC202, its lead drug candidate, has entered Phase I clinical trials in cancer patients.

202 is a novel cell cycle drug belonging to the Cyclin Dependent Kinase (CDK) inhibitor class. CDK inhibition has been widely recognised as an important new area in the quest for drugs that target the molecular mechanism of the body's own cancer stopping genes. In preclinical studies CYC202 demonstrated high specificity against the drug target CDK2. CYC202 is supplied in capsules and is the first drug in its class that is available by mouth.

CYC202 Phase I trial is taking place at The Royal Marsden Hospital (Sutton, Surrey, UK) following clearance of a Cyclacel CTX application with the UK Government and a corresponding clearance by the Hospital's ethics committee. The trial will evaluate the pharmacokinetics and toleration of CYC202 in cancer patients. If this first study proves successful, additional Phase I studies will be initiated later in 2001 to further explore the safety and activity of CYC202.

tis, Cyclacel's Chief Executive, "Initiation of CYC202 clinical trials marks the culmination of many months of hard work by Cyclacel and our collaborators. We are pleased to have achieved this milestone and look forward to exploring CYC202's properties in man. Although a lot of effort lies ahead before we can determine the clinical utility of CYC202, we also look forward to advancing our other drug candidates to clinical trials with a view to constructing a promising drug pipeline."

avid Lane, Cyclacel's Chief Scientific Officer, "One of the main reasons I established Cyclacel was to quickly bring the benefits of scientific discoveries to the bedside of cancer patients. I am very excited to be part of a Cyclacel team that achieved this goal three years after beginning operations. CDK inhibitors are a new family of anticancer drugs that may work by the same mechanism as the body's own anticancer genes. Unlike conventional chemotherapies they are not likely to cause massive damage to normal cells."