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CAMBRIDGE, MA 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. FK228 is one of a new class of anti-cancer agents, known as histone deacetylase inhibitors. FK228 was granted Fast Track designation by the Food and Drug Administration as a monotherapy for the treatment of cutaneous T-cell lymphoma in patients who have relapsed following, or become refractory to, one other systemic therapy. The product is currently being evaluated in a range of hematologic and solid tumor indications including CTCL, renal cell carcinoma and hormone refractory prostate cancer in clinical trials sponsored by Gloucester, as well as the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA). Gloucester acquired the rights to FK228 from Fujisawa Pharmaceutical Co, Ltd. in April 2004 under an exclusive, worldwide license agreement. A Special Protocol Assessment is a request for feedback from the FDA that allows a company to receive official evaluation, guidance and agreement on pivotal clinical trial protocols. A company can request this formal assessment on pivotal trials that may form the primary basis of an efficacy claim in an NDA. About CTCL CTCL is a group of diseases, including Mycosis Fungoides and S³zary syndrome, all constituting types of non-Hodgkin's lymphoma in which certain cells of the lymph system (T cells) become cancerous and affect the skin. The disorder is characterized by abnormal accumulation of malignant T-cells in the skin, which result in the development of itchy rashes, plaques and tumors. Occasionally malignant cells can be found circulating in the bloodstream and visceral (internal organ) involvement can occur. There are about 40,000 CTCL patients worldwide. 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. The company employs an in-licensing strategy to build a diversified product portfolio to address the significant unmet medical need in the management of cancer. Gloucester's first product is FK228, a novel HDAC inhibitor, which the company acquired from Fujisawa Pharmaceutical Co, Ltd. in April 2004. Gloucester is headquartered in Cambridge, MA. For more information visit our website at www.gloucesterpharma.com. This press release contains forward-looking statements concerning Gloucester that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Gloucester's actual results to differ materially from those indicated by such forward-looking statements, including risks as to whether results obtained in pre-clinical and early clinical studies such as the results referred to in this release will be indicative of results obtained in future clinical trials; whether FK228 will advance through the clinical trial process and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies and for which indications, if any; and whether the patent and patent applications owned or licensed by Gloucester will protect the Company's technology and prevent others from infringing it. Gloucester disclaims any intention or obligation to update any forward-looking statements. Investors Beverly Holley info@gloucesterpharma.com (617) 583-1362 Media Kathryn Morris KMorrisPR kathryn@kmorrispr.com (845) 635-9828 |
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Copyright ©2007 Rho Capital Partners, Inc.