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Gloucester Pharmaceuticals Initiates Phase I/II Clinical Study in Pancreatic and Other Advanced Solid Tumors; Combination Trial Will Investigate Romidepsin (Depsipeptide) in Combination with Gemcitabine.

CAMBRIDGE, Mass. -- Gloucester Pharmaceuticals, Inc., a privately held cancer therapeutics development company, announced today that it has enrolled and treated the first patient in a phase I/II clinical study of romidepsin in combination with gemcitabine to treat pancreatic cancer and other solid tumors.

The Company anticipates enrolling approximately 30 patients in an open-label, single-arm study. Patients will receive romidepsin and gemcitabine at various doses in order to establish the most appropriate dose for each drug in this combination regimen. Once the appropriate dose of each drug is determined, additional patients will be treated at that dosing regimen. The endpoints for this trial include both safety and objective response to therapy.

"This clinical trial will expand on recent preclinical data suggesting that romidepsin may enhance the activity of gemcitabine," commented Howard Burris, M.D., of the Sarah Cannon Research Institute and principal investigator of the study. "Gemcitabine is already approved for the treatment of pancreatic cancer and we hope to find that using it in combination with romidepsin may improve patient outcomes. Despite recent advances, pancreatic cancer is still a leading cause of cancer death in the United States and innovative new treatments are clearly needed," he concluded.

About Romidepsin (Depsipeptide)

In July 2006 the International Nonproprietary Names (INN) body of the World Health Organization (WHO) and the United States Adopted Names (USAN) Council approved the nonproprietary (generic) name romidepsin for depsipeptide (FK228). Romidepsin is a novel agent in a new class of anti-cancer drugs known as histone deacetylase inhibitors. The Company is conducting a pivotal study of romidepsin for patients with cutaneous T-cell lymphoma (CTCL). Interim data for this trial, recently presented at the American Society of Clinical Oncology meeting, included 40 patients enrolled and 28 evaluable patients. The overall response rate was 36% (10/28) with 7% of patients achieving a complete response. The most common adverse events seen in this trial were nausea (52%), fatigue (33%) and vomiting (26%). This study is currently accruing patients. Romidepsin has received both Fast Track and Orphan Drug Designation by the Food and Drug Administration (FDA), and Orphan Drug Designation from the European Agency for the Evaluation of Medicinal Products (EMEA). Romidepsin is also in clinical trials for a variety of other hematologic malignancies and solid tumors including peripheral T-cell lymphoma, hormone refractory prostate 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 and 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 or call 888-GPI-CTCL (888-474-2825).

Information on Gloucester's clinical trials can also be found at: regarding cutaneous T-cell lymphoma regarding prostate cancer
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Publication:Business Wire
Date:Sep 12, 2006
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