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Cyclacel's biomarker technology shows that CYC202 induces cancer cells to commit suicide

r cells as a result of apoptosis. In this manner small blood samples can be readily obtained from patients with solid tumours rather than tissue pathology samples obtained through biopsies. Another approach taken by Cyclacel's Biomarker Team is the study of plasma proteomic profiles allowing the precise comparison of the proteins present in a patient's plasma before and after treatment with CYC202. Using this approach markers were detected that are only present in plasma following CYC202 treatment.

Phase I trials are not designed to detect efficacy of experimental drugs. Patients enrolled in Phase I studies suffer from many different types of cancer, have typically exhausted other therapeutic alternatives and usually experience low survival. In order to assess their prognosis it is necessary to wait for approximately six months post treatment to determine whether their cancer has continued to grow. The seven patients in the CYC202 Phase I study reported with stable disease included patients with adenocarcinoma, adrenal, lung, ovarian, pancreatic, parotid gland and thymus cancers. All seven showed long Times-To-Progression ("TTP") of their cancer, ranging between 7 and more than 11 months, and have been on drug for several months, ranging between 6 and more than 15 cycles each involving 3 weeks of treatment.

Dr Athos Gianella-Borradori, Cyclacel's Medical Director commented, "It is encouraging to see validation of the presumed mechanism by which CYC202 is causing the death of cancer cells through biomarker technology. It is also encouraging to see Phase I patients with poor prognosis experience long periods of stable disease after single therapy with CYC202. One should nevertheless be cautious about not over interpreting early indications of effectiveness from unscheduled efficacy assessments. Now that we have established a baseline for quantifying apoptosis in patients undergoing CYC202 monotherapy, we can use such biomarker techniques to
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Contact: Robert Gottlieb
robert.gottlieb@fkhealth.com
617-577-8110
Feinstein Kean Healthcare
14-Jul-2003


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