Gloucester Pharmaceuticals Receives Special Protocol Assessment for Pivotal Phase II Trial of Romidepsin in Patients with Peripheral T-Cell Lymphoma

Business Wire, Jan 30, 2007

CAMBRIDGE, Mass. -- Gloucester Pharmaceuticals, Inc., an oncology focused specialty pharmaceutical company, announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under the FDA's Special Protocol Assessment (SPA) process for the design of its planned pivotal trial of romidepsin in patients with peripheral T-cell lymphoma (PTCL). This single-arm trial will enroll PTCL patients who have progressed or become refractory following systemic therapy.

A Special Protocol Assessment is a request for feedback from the FDA that allows a company to receive official evaluation and guidance on the design and size of pivotal clinical trial protocols. A company can request this formal assessment on a pivotal trial that is intended to form the primary basis of an efficacy claim in a New Drug Application (NDA).

"PTCL is a challenging disease for which there are no currently approved drugs," commented Jean Nichols, Ph.D., Executive Vice President and Chief Scientific Officer at Gloucester Pharmaceuticals. "We continue to see encouraging data for romidepsin in T-cell malignancies, including recently presented data from an NCI-sponsored study in PTCL that included a significant overall response rate and duration of response in previously treated patients. We expect to initiate our pivotal study later this quarter," she concluded.

At the recent 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 was reported as 12 months. The most common adverse events reported were fatigue, nausea, and vomiting.

About PTCL

Peripheral T-cell lymphoma is a term which encompasses a number of different malignancies of T-cell origin that account for about 10-15% of all cases of non-Hodgkin's lymphoma. PTCL can occur at any age from young adulthood to old age and is slightly more common in men than in women. It is a particularly aggressive form of lymphoma with a short median duration of life expectancy (approximately two years) from diagnosis.

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 is initiating a pivotal phase II study for patients with peripheral T-cell lymphoma (PTCL). 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) for CTCL. It has also received Orphan Drug Designation for PTCL from both the FDA and EMEA. Romidepsin is also in clinical trials for a variety of other hematologic 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 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 www.gloucesterpharma.com or call 888-474-2825.