Gloucester Pharmaceuticals Announces Initiation of Phase I/II Clinical Trial in Patients with Multiple Myeloma.

In Preclinical Studies, Novel HDAC Inhibitor Romidepsin Demonstrated Synergistic Activity When Combined with VELCADE([R] )(Bortezomib) in Multiple Myeloma Cells

CAMBRIDGE, Mass. -- Gloucester Pharmaceuticals, Inc., an oncology focused specialty pharmaceutical company, announced today that the first patient has been treated in a phase I/II investigator-initiated clinical study of romidepsin in combination with bortezomib to treat patients with relapsed/refractory multiple myeloma. The study is being conducted at the Peter MacCallum Cancer Centre in Melbourne, Australia.

The investigator, Professor Miles Prince, anticipates enrolling approximately 25 patients in a phase I/II dose-escalation study. Patients will receive bortezomib at a fixed standard dosing regimen and romidepsin at increasing doses in order to establish the most appropriate dose for each drug in this combination regimen. Once the appropriate dosage is determined, additional patients will be treated at that dosing regimen. The endpoints for this trial include both objective response and safety.

"We are very excited to be working towards what may become a new treatment approach for this difficult disease," stated Miles Prince, M.D., Chair of Clinical Cancer Services at the Peter MacCallum Cancer Centre and principal investigator of the study. "Romidepsin appears to be a promising investigational drug and pre-clinical data indicate that the romidepsin and bortezomib combination is synergistic. It is our hope that the combination of romidepsin and bortezomib will prove beneficial to patients and we are pleased to initiate the first clinical trial of this combination in Australia," he concluded.

"The initiation of this clinical trial is an important step in Gloucester's continued development of romidepsin," commented Mitchell Keegan, Ph.D., Senior Director of Drug Development at Gloucester. "We now have ongoing clinical trials in five hematologic and solid tumor indications, including pivotal registration trials in cutaneous T-cell lymphoma and peripheral T-cell lymphoma."

About Multiple Myeloma

Multiple Myeloma is a type of blood cancer in which plasma cells grow, divide and accumulate in the bone marrow, resulting in the decreased production of normal red and white bloods as well as the decreased production of disease-fighting antibodies. According to the Multiple Myeloma Research Foundation, 5-6 new cases of multiple myeloma per 100,000 persons will occur in the U.S. each year.

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.