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Gloucester Pharmaceuticals Reports on Romidepsin and Erlotinib,Combination in Non-Small Cell Lung Cancer Presented at American,Association of Cancer Research Annual Meeting

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr 18, 2007 - Gloucester Pharmaceuticals, Inc., an oncology focused biopharmaceutical company, announced today that encouraging data from a preclinical study examining the combination of romidepsin and erlotinib in non-small cell lung cancer (NSCLC) cell lines derived from human cancer patients were presented at the American Association of Cancer Research Meeting annual meeting taking place in Los Angles, CA. The study was co-authored by Wei Zhang, Ph.D., Michael Peyton, Ph.D., John D. Minna, M.D., Adi F. Gazdar, M.D. and Eugene P. Frenkel, M.D., all of the Hamon Center for Therapeutic Oncology Research at University of Texas Southwestern Medical Center.

In an oral presentation entitled "Histone deacetylase inhibitor romidepsin enhances anti-tumor effect of erlotinib in non-small cell lung cancer (NSCLC) cell lines" Dr. Zhang showed data from a preclinical study designed to examine the effect of the histone deacetylase (HDAC) inhibitor romidepsin in combination with the tyrosine kinase inhibitor (TKI) erlotinib in NSCLC. In the in vitro arm of the study, 22 NSCLC cell lines were treated with either romidepsin, erlotinib or romidepsin and erlotinib together. For the in vivo arm of the study H1299 xenografts were inoculated subcutaneously into nude mice. The developing tumors were treated with either romidepsin, erlotinib or romidepsin and erlotinib together.

In her conclusions Dr. Zhang reported that romidepsin synergistically enhanced erlotinib sensitivity in wild type NSCLC cell lines by induction of profound apoptosis. This synergy was also shown in the nude mice xenografts but was not observed in epidermal growth factor (EGFR) mutant cell lines.

"The data from this study are very promising and suggest that combining romidepsin with TKIs such as erlotinib may enhance the clinical activity in the non-EGFR mutant patient population, which is thought to be approx imately 75-80% of NSCLCs," commented Jean Nichols, Ph.D., Executive Vice-President and Chief Scientific Officer at Gloucester.

"The preclinical synergy seen in this study provides a strong rationale for conducting clinical studies of the combination. If similar results are seen clinically, the potential exists to substantially increase the use of TKIs such as erlotinib in a broader population of lung cancer," she concluded.

About Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer-related deaths worldwide. There are over 1.2 million cases of lung cancers every year in the world, and 1.1 million people will die from their disease. Non-small cell lung cancer accounts for approximately 80% of lung cancer.

About Romidepsin

Romidepsin is a novel agent in a new class of anti-cancer drugs known as histone deacetylase inhibitors. The Company is conducting a pivotal phase II study of romidepsin for patients with cutaneous T-cell lymphoma (CTCL) and has initiated a pivotal phase II study for patients with peripheral T-cell lymphoma (PTCL). Romidepsin has received Orphan Drug Designation from the Food and Drug Administration (FDA) for the treatment of non-Hodgkin T-cell lymphomas, which includes CTCL and PTCL. In addition, the European Agency for the Evaluation of Medicinal Products (EMEA) has issued Orphan Drug status for the treatment of both CTCL and PTCL. Fast Track status for CTCL has also been designated by the FDA. Romidepsin is in clinical trials for a variety of other hematological malignancies and solid tumors, including hormone refractory prostate cancer, pancreatic cancer and multiple myeloma. These trials and others are being conducted by the Company or the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) with the Company.

About Gloucester Pharmaceuticals, Inc.

Gloucester Pharmaceuticals, Inc. is a privately-held, venture-backed company that develops an d commercializes innovative products for the treatment of cancer patients. Gloucester is headquartered in Cambridge, MA. For more information on Gloucester and our clinical development program visit our website at www.gloucesterpharma.com or call 888-474-2825.

Contact

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KMorrisPR
Kathryn Morris, 845-635-9828
kathryn@kmorrispr.com
or
Gloucester Pharmaceuticals
Beverly Holley, 617-583-1362
beverly.holley@gloucesterpharma.com


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