Investors
News Release
Vall d’Hebron University Hospital and Cyclacel to initiate Phase 1 combination study of Seliciclib and Tarceva®
May 29 2008
BARCELONA, SPAIN AND BERKELEY HEIGHTS, NJ – May 29, 2008 – 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.”
About Vall d’Hebron University Hospital and Professor Emiliano Calvo
Vall d’Hebron University Hospital (http://www.vhebron.es/vhang.htm) is the leading hospital complex in Catalonia and one of the largest in Spain. In addition to its clinical research capabilities it facilitates translational research and innovation within the health and biomedical fields, particularly in cancer and rare diseases.
Professor Emiliano Calvo’s work at Vall d’Hebron University Hospital focuses on the development of new cancer agents. He has been with the hospital’s Medical Oncology Department since 2005, where he is Senior Specialist in the areas of Genitourinary Tumors and Sarcomas and the Development of New Cancer Drugs. He is also a Consultant at the Instituto Oncológico Baselga, Quirón Hospital, Barcelona.
Prior to Vall d’Hebron University Hospital, Professor Calvo held positions at the University Clinic of Navarra in Pamplona, Spain, from which he graduated as Doctor in Medical Oncology, the Institute for Drug Development of the Cancer Therapy and Research Center in San Antonio, Texas, and the National Cancer Institute in Maryland. He earned his medical degree at the Autonomous University of Madrid after receiving a study grant from the Boston University School of Medicine. He is a reviewer for various oncology journals and is an active member of the Spanish Society of Medical Oncology, the American Society of Clinical Oncology, the European Society of Medical Oncology, and the American Association of Cancer Research. He is also a Faculty member of the Clinical Trials and Systemic Therapy Group of the Educational Committee of the European Society of Medical Oncology. Professor Calvo has written approximately 150 national and international publications and has participated as an investigator in numerous national and international clinical trials.
About Cyclacel Pharmaceuticals, Inc.
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. Three Cyclacel drugs are in clinical development. Sapacitabine (CYC682), an orally-available cell cycle modulating nucleoside analog, is in Phase 2 studies for the treatment of acute myeloid leukemia in the elderly and cutaneous T-cell lymphoma (CTCL). Seliciclib (CYC202 or R-roscovitine), an orally-available CDK (cyclin dependent kinase) inhibitor, is in Phase 2 for the treatment of lung cancer and nasopharyngeal cancer. CYC116, an orally-available, Aurora kinase and VEGFR2 inhibitor, is in Phase 1 in patients with solid tumors. Several additional programs are at an earlier stage. Cyclacel’s ALIGN Pharmaceuticals subsidiary markets directly in the U.S. Xclair™ Cream for radiation dermatitis, Numoisyn™ Liquid and Numoisyn™ Lozenges for xerostomia. Cyclacel’s strategy is to build a diversified biopharmaceutical business focused in hematology, oncology and other therapeutic areas based on a portfolio of commercial products and a development pipeline of novel drug candidates.
Please visit www.cyclacel.com for additional information. Note: The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc. Numoisyn™ and Xclair™ are trademarks of Sinclair Pharma plc. Tarceva® is a trademark of OSI Pharmaceuticals, Inc.
Risk Factors
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety, and intended utilization of Cyclacel's product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, the risk that Cyclacel will not obtain approval to market its products, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. These factors and others are more fully discussed under "Risk Factors" in the Annual Report on Form 10-K for the year ended December 31, 2007, as supplemented by the interim quarterly reports, filed with the SEC.
Contacts for Cyclacel: |
||
Cyclacel Pharmaceuticals, Inc. | WeissComm Partners | College Hill, Life Sciences |
Corey Sohmer | Aline Schimmel | Sue Charles & Justine Lamond |
(908) 517-7330 | (312) 284-4706 | +44 (0)20 7866 7857 |