Gloucester Pharmaceuticals Announces Expansion of Pivotal Trial of Depsipeptide in Cutaneous T-Cell Lymphoma; Clinical Sites Now Include Major Medical Centers in US.

CAMBRIDGE, Mass. -- Gloucester Pharmaceuticals, Inc., a privately held cancer therapeutics development company, today announced that it has expanded its multinational clinical trial of depsipeptide (FK228) for the treatment of cutaneous T-cell lymphoma (CTCL) to include clinical sites in the United States in addition to the active clinical sites in the United Kingdom, Poland, and Germany.

"We are very pleased to add US clinical sites to our ongoing pivotal study in CTCL," said William McCulloch, M.B., FRCP, Executive Vice-President and Chief Medical Officer at Gloucester Pharmaceuticals. "We believe that depsipeptide has the potential to be an important new treatment option for T-cell lymphoma patients and we are pleased that our trial continues to progress," he concluded.

In December 2005, interim results of an ongoing Phase 2 trial of depsipeptide being conducted by the National Cancer Institute (NCI) were presented at the 47th Annual Meeting of the American Society of Hematology. In an oral presentation, Dr. Richard L. Piekarz of NCI discussed data on 27 CTCL patients enrolled in the first cohort of the trial. In the presentation, Dr. Piekarz noted that the overall response rate was 37% with a median duration of response of 12.5 months. Three patients (11%) with Sezary syndrome achieved a complete response and partial responses were observed in seven patients (26%). Six patients (22%) had stable disease with a median duration to date of 6 months.

About Depsipeptide (FK228)

Depsipeptide is one of a new class of anti-cancer agents, known as histone deacetylase inhibitors. Depsipeptide was granted Fast Track and Orphan Drug designations by the Food and Drug Administration and European Orphan Drug designation by the EMEA as a monotherapy for the treatment of cutaneous T-cell lymphoma in patients who have relapsed following, or become refractory to, one other systemic therapy. Gloucester is currently evaluating depsipeptide in a pivotal clinical trial for CTCL. The U.S. Food and Drug Administration (FDA) reviewed the trial protocol under its Special Protocol Assessment (SPA) process prior to the initiation of the pivotal study. Depsipeptide is also being studied in a range of hematologic and solid tumor indications including hormone refractory prostate cancer in clinical trials sponsored by Gloucester, as well as the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) with Gloucester.

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. The Company employs an in-licensing strategy to build a diversified product portfolio to address the significant unmet medical need in the management of cancer. Gloucester's first product is depsipeptide, a novel HDAC inhibitor. Gloucester is headquartered in Cambridge, MA. For more information about Gloucester visit our website at www.gloucesterpharma.com.

For more information on Gloucester's clinical trial, please call 888-GPI-CTCL (474-2825) or visit www.clinicaltrials.gov/ct/show/NCT00106431.