Gloucester Pharmaceuticals to Present Interim Pivotal Clinical Trial Data at the 2006 Annual Meeting of The American Society of Clinical Oncology.CAMBRIDGE, Mass. -- Gloucester Pharmaceuticals, Inc., a privately held cancer therapeutics development company, announced today that interim data from the Company's pivotal trial of depsipeptide for cutaneous T-cell lymphoma Cutaneous T-Cell Lymphoma Definition Cutaneous T-cell lymphoma (CTCL) is a malignancy of the T-helper (CD4+) cells of the immune system. Description will be presented at the 2006 Annual Meeting of the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. (ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company ) to be held in Atlanta, GA June 2-6, 2006. Dr. Sean Whittaker of the St. Thomas's Hospital, London UK will present Abstract # 3063 "International Multicenter Phase II Study of the HDAC Inhibitor Depsipeptide (FK228) in Cutaneous T-cell Lymphoma (CTCL CTCL Cutaneous T Cell Lymphoma ) - Interim Report" in a poster session on Sunday, June 4 from 2:00-6:00 pm. The poster will be presented in a general poster session entitled "Developmental Therapeutics: Molecular Therapeutics" in Building B, Level 1, Hall B5 of the Atlanta World Conference Center. This Gloucester-sponsored pivotal trial is a Phase II, non-randomized, open label, single arm study that is being conducted in patients with CTCL at approximately 25 sites in the US and Europe. Full text of the abstract will be available through the ASCO website at www.asco.org. The Company also announced that it would be sponsoring a medical information exhibit in Booth #4273 during the meeting. Members of Gloucester's clinical affairs staff will be available Saturday, June 3rd through Monday, June 5th to discuss the Company's clinical development plans and corporate activities. 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. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) 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 for CTCL by the FDA, and Orphan Drug Designation from the EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. , as monotherapy for CTCL patients who have relapsed, or become refractory to, at least one prior systemic therapy. Depsipeptide is in Phase II trials for a variety of other hematologic malignancies and solid tumors including peripheral T-cell lymphoma, hormone refractory prostate cancer and multiple myeloma. These trials and others are being conducted by the Company or the National Cancer institute (NCI See Liberate. ), under a Cooperative Research and Development Agreement “CRADA” redirects here. For other uses, see CRADA (disambiguation). A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together. (CRADA CRADA Cooperative Research And Development Agreement ) 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 visit our website at www.gloucesterpharma.com. For more information on Gloucester's clinical trials, please call 888-474-2825 or visit www.clinicaltrials.gov/ct/show/NCT00106431 regarding Cutaneous T-Cell Lymphoma or www.clinicaltrials.gov/ct/show/NCT00106418 regarding prostate cancer. |
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