Gloucester Pharmaceuticals, Inc. Initiates Pivotal Trial With FK228 In Cutaneous T-Cell Lymphoma; FDA Approves Trial Protocol Under Special Protocol Assessment
10/19/2005 5:12:52 PM
CAMBRIDGE, Mass.--(BUSINESS WIRE)--March 1, 2005--Gloucester Pharmaceuticals, Inc., a privately held cancer therapeutics development company, announced today that it has initiated a pivotal trial of its novel histone deacetylase (HDAC) inhibitor, FK228 (depsipeptide), for the treatment of cutaneous T-cell lymphoma (CTCL). The Company also announced that the U.S. Food and Drug Administration (FDA) had approved the trial protocol under its Special Protocol Assessment (SPA) process prior to the Company beginning the pivotal study.
"We are delighted to commence the pivotal trial for FK228 in CTCL," said Joseph S. "Jay" Mohr, President and Chief Executive Officer of Gloucester Pharmaceuticals, Inc. "We have accomplished many key objectives since acquiring FK228 last year and look forward to completing the pivotal trial, which we hope will lead to regulatory approval," he concluded.