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Cyclacel Group PLC Announces Cyclacel Designates Aurora Kinase Inhibitor As Its Third Development Candidate

Posted on: Wednesday, 9 November 2005, 09:00 CST

 For immediate release                               CYCLACEL DESIGNATES            AURORA KINASE INHIBITOR AS ITS THIRD DEVELOPMENT CANDIDATE New York, (Dundee, Scotland, UK), November 9, 2005 - Cyclacel Group plc  ("Cyclacel"), the cell cycle-focused biopharmaceutical company, announced today that CYC116 an Aurora kinase inhibitor, has entered IND-directed preclinical development.  CYC116 is a small molecule investigational drug which demonstrated anticancer activity after oral administration in both hematological and solid tumor models.  The company plans to file an Investigational New Drug (IND) application for CYC116 with the United States Food and Drug Administration in 2006. CYC116, the third orally-available Cyclacel drug to enter development, was selected from over a hundred molecules synthesized by the company's scientists. CYC116 and selected backup compounds demonstrated anticancer activity in solid tumor and hematological cancer models with a mechanism consistent with inhibition of Aurora kinase. The announcement was made by Cyclacel's CEO, Spiro Rombotis, during the company's presentation at the Rodman & Renshaw Techvest 7th Annual Healthcare Conference taking place in New York. "We are excited to enter IND-directed preclinical development with CYC116. Together with seliciclib and sapacitabine, our two clinical development candidates, advancement of CYC116 demonstrates our strategy of building a novel oncology-focused pipeline of drugs acting on the cancer cell cycle," he commented. Prof. David Glover, Chief Scientist of Cyclacel's Polgen Division, who discovered the Aurora, polo and other mitotic kinases, said: "I am delighted to have participated in all of the stages from the discovery of the Aurora kinases to the development of their inhibitors as potential agents for cancer therapy. It has been very exciting to see the development of these Aurora kinase inhibitors from our in-house program progress very quickly allowing us to select  CYC116 as a lead development candidate from several compounds which have demonstrated efficacy by oral administration in hematological and solid tumor models with a mechanism consistent with Aurora inhibition. As important regulators of both genomic integrity and cell cycle progression in cancer cells the Aurora kinases represent an attractive target for anticancer drug development." Aurora kinases are enzymes that help dividing cells share their materials among two daughter cells.  In many people with cancer Aurora kinase malfunctions and normal control of cell division is lost resulting in abnormal growth.  Small molecule drugs that inhibit Aurora kinase may slow down the growth of cancer cells and lead to their death by apoptosis. 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. Sapacitabine (CYC682) is an orally-available, cell cycle modulating nucleoside analog in Phase I clinical trials for the treatment of cancer. CYC116 is an orally-available, Aurora kinase inhibitor in IND-directed preclinical development. Several additional programs are at an earlier stage. Contacts for further information: Cyclacel:                                                     +44 (1382) 206 062 Spiro Rombotis, Chief Executive Officer Paul McBarron, Chief Financial Officer Buchanan Communications: Mark Court/Tim Anderson/Mary-Jane Johnson                     +44 (20) 7466 5000 Feinstein Kean Healthcare: Robert Gottlieb                                                +1 (617) 577 8110                                    - # # # - Notes for Editors: Professor David Glover, FRSE, Chief Scientist, Polgen Division. Professor Glover joined Cyclacel in November 1999. He is Arthur Balfour Professor of Genetics and Chairman in the Department of Genetics at the University of Cambridge. He is also Director of Cancer Research UK Cell Cycle Genetics Research Group. He was previously Professor of Molecular Genetics at the University of Dundee and Professor and Head of Biochemistry at Imperial College, London. Professor Glover discovered and named the Polo and Aurora mitotic protein kinases and coordinated the former European Drosophila Genome Project, the European academic consortium contributing to sequencing the fruit fly genome. He is a member of the European Molecular Biology Organisation and has authored over 200 publications and patents. Cancer and Aurora Kinase Inhibitors Cancer is the second leading cause of death in the Western World.  Solid tumors represent a major public health issue with an incidence of over 2 million people.  Breast, colorectal, lung, prostate cancer and leukemia are the most common.  Survival rates tend to be poor in many cancers and demographic changes and graying populations suggest that new cases of cancer are on the rise. Increased understanding of the molecular and genetic mechanism causing cancer have raised expectations that mechanism-targeted drugs may complement existing chemotherapies with the objective of increasing effectiveness and decreasing toxic side effects of modern cancer therapeutics. Mitosis is the last stage of the cell division cycle during which copied genetic material from the nucleus of a parent cell is endowed into two daughter cells. The accuracy of the mitotic process determines the survival of the daughter cells.  To ensure the integrity of this process the body uses mechanisms such as the Aurora kinases to check cells for errors that may cause genomic instability and result in cancer. Aurora kinases are enzymes discovered by Professor David Glover(1) that help cells regulate how they share their materials among two daughter cells as they divide during mitosis.  This mechanism helps regulate how cells grow and multiply.  In many people with cancer, including leukemia, colon and breast tumors, Aurora kinase malfunctions and normal control of cell division is lost resulting in abnormal growth.  Small molecule drugs that inhibit Aurora kinase may slow down the growth of cancer cells and lead to their death. Literature references suggest that Aurora kinase inhibitor drugs do not induce cell cycle arrest in cancer cells as is the case with classical anti-mitotic agents such as the taxanes.  Instead Aurora kinase inhibitors delay entry into mitosis and drive cells into an aberrant mitosis condition called mitotic catastrophe.  In effect these drugs disrupt the genome and derail the orderly division of cancer cells in the next cell cycle causing their death.  The distinct mechanism of Aurora kinase inhibitors suggests the possibility of synergy in combination with anti-mitotic drugs. (c) 2004 - Cyclacel Group plc.  Cyclacel(R), Fluorescience(R), Penetratin(R) and Polgen(R) are registered trademarks. -------------------------- (1) Glover D.M., Leibowitz M.H., McLean D.A., Parry H.  Mutations in aurora prevent centrosome separation leading to the formation of monopolar spindles. Cell 1995 Apr 7:81(1):95-105.                       This information is provided by RNS             The company news service from the London Stock Exchange 

SOURCE: Cyclacel Group PLC

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