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Gloucester Pharmaceuticals Receives Fast Track Designation for,Romidepsin in Peripheral T-Cell Lymphoma

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 16, 2007 - Gloucester Pharmaceuticals, Inc., an oncology focused biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its novel histone deacetylase inhibitor, romidepsin, for the monotherapy of previously treated peripheral T-cell lymphoma (PTCL). The Company had previously announced that it has reached an agreement with the FDA under the FDA's Special Protocol Assessment (SPA) process for the design of its registration-directed trial of romidepsin in patients with PTCL, and that it has received Orphan Drug Status covering this indication in both the United States and Europe.

"The receipt of Fast Track Designation for PTCL is an important component of our overall product development strategy for romidepsin," commented John McBride, Executive Vice President and Chief Operating Officer at Gloucester. "We now are extremely well positioned to move forward with clinical development of romidepsin for PTCL, having previously secured Orphan Drug Designation and finalized a Special Protocol Assessment with the FDA for this indication. As a novel agent in a new class of drugs, histone deacetylase inhibitors, we believe romidepsin has significant potential as a treatment for a variety of hematological cancers as well as solid tumors," he concluded.

At the American Society of Hematology Annual Meeting held in December 2006 an interim analysis of the NCI's phase II study of romidepsin as a treatment for PTCL was presented. The interim results reported on 36 patients with PTCL. An overall response rate of 30% (11/36) was reported, with 3 complete responses (8%) and 8 partial responses (22%). The overall median duration of response has not yet been reached but was reported as being greater than 12 months. The most common adverse events reported were fatigue, nausea, and vomiting.

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