New drug Depsipeptide (FK228)

Data Safety Monitoring Board Recommends Continuation of Gloucester Pharmaceuticals' Pivotal Trial for Depsipeptide in Cutaneous T-Cell Lymphoma

Gloucester Pharmaceuticals, Inc., announced today that an independent Data Safety Monitoring Board (DSMB) has reviewed interim safety data in its international pivotal trial evaluating the Company's depsipeptide product as a treatment for cutaneous T-cell lymphoma (CTCL). The DSMB recommended that Gloucester continue the trial without any modifications.

Data Safety Monitoring Boards are comprised of independent medical experts, including physicians and statisticians, who are not involved in the clinical trial under review. The DSMB 's focus is patient safety and it is responsible for monitoring the safety data from patients participating in the trial and providing feedback and recommendations to the sponsoring organization.

Gloucester's pivotal clinical CTCL trial is a Phase II, non-randomized, open label, single arm study that is being conducted at approximately 20 sites in the US and Europe.

About Depsipeptide (FK228)

Depsipeptide 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 depsipeptide for patients with cutaneous T-cell lymphoma (CTCL). The U.S. FDA reviewed the trial protocol under its Special Protocol Assessment (SPA) process prior to the initiation of the pivotal study. Depsipeptide has received both Fast Track and Orphan Drug designation by the FDA, and Orphan Drug Designation from the EMEA, as monotherapy for cutaneous T-cell lymphoma patients who have relapsed, or become refractory to, at least one prior systemic therapy. Depsipeptide 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.

Source: www.gloucesterpharma.com