Study: Phase I Trial Seliciclib and Tarceva

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http://www.medicalnewstoday.com/articles/109188.php

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Vall d'Hebron University Hospital and Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) announced a collaboration to conduct a Phase 1 study of investigational therapy seliciclib in combination with erlotinib (Tarceva®) in patients with advanced solid tumors including non-small cell lung cancer (NSCLC). Seliciclib, Cyclacel's orally available cyclin dependent kinase (CDK) inhibitor, has shown encouraging anti-cancer activity in several Phase 1 and Phase 2 studies. Seliciclib is currently being tested as a single agent in the treatment of patients with non-small cell lung cancer in the Phase 2b APPRAISE trial and in a Phase 2 study in patients with nasopharyngeal cancer.

The Phase 1 combination study of seliciclib and Tarceva will be led by Professor Emiliano Calvo, M.D., Ph.D., Co-director of the Early Drug Development Program at Vall d'Hebron University Hospital, Barcelona, Spain, a medical center globally acclaimed for its clinical development programs with targeted anti-cancer agents, and in particular epidermal growth factor receptor (EGFR) inhibitors including Tarceva.

"We have received approval by our institutional Ethics Committee to conduct this Phase 1 trial. The primary objective of the study is to determine the recommended dose of seliciclib in combination with Tarceva. Secondary objectives include the evaluation of potential pharmacokinetic interactions between seliciclib and Tarceva and potential alterations of signal transduction biomarkers occurring downstream of EGFR, such as cyclin D1, by the combination of these two agents," said Professor Calvo.

The rationale of this clinical study is based on preclinical data demonstrating that the combination of seliciclib and Tarceva act synergistically in suppressing tumor growth in models of NSCLC presented in April 2007 at the Annual Meeting of the American Association for Cancer Research (AACR) in Los Angeles.

"We are delighted that Professor Calvo and Vall d'Hebron University Hospital, a preeminent research center in the field of EGFR inhibitors, are interested in initiating a combination study of seliciclib and Tarceva," said Spiro Rombotis, president and chief executive officer of Cyclacel. "Several published preclinical studies suggest a potential benefit when CDK inhibitors, such as seliciclib, are given in combination with EGFR inhibitors and other targeted agents. We believe that this is an important scientific hypothesis to explore in clinical trials."

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(Medical News Tdoay, Lung Cancer, Cancer/Oncology, Clinical Trials, Drug Trials, May 30, 2008. [Contains Forward-looking Statements.})

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