Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin in Peripheral T-Cell Lymphoma.-- 2(nd) fast track designation for romidepsin in the treatment of T-cell lymphomas -- CAMBRIDGE, Mass. -- Gloucester Pharmaceuticals, Inc., an oncology focused biopharmaceutical company, announced today that 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. ) has granted Fast Track designation for its novel histone deacetylase inhibitor, romidepsin, for the monotherapy of previously treated peripheral T-cell lymphoma (PTCL PTCL Pakistan Telecommunication Company Limited PTCL Peripheral T Cell Lymphoma PTCL Physical and Theoretical Chemistry Laboratory PTCL Pakistan Tobacco Company Limited ). The Company had previously announced that it has reached an agreement with the FDA under the FDA's Special Protocol Assessment (SPA) process for the design of its registration-directed trial of romidepsin in patients with PTCL, and that it has received Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the Status covering this indication in both the United States and Europe. "The receipt of Fast Track Designation for PTCL is an important component of our overall product development strategy for romidepsin," commented John McBride, Executive Vice President and Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. at Gloucester. "We now are extremely well positioned to move forward with clinical development of romidepsin for PTCL, having previously secured Orphan Drug Designation and finalized a Special Protocol Assessment with the FDA for this indication. As a novel agent in a new class of drugs, histone deacetylase inhibitors, we believe romidepsin has significant potential as a treatment for a variety of hematological hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. cancers as well as solid tumors," he concluded. At the American Society of Hematology Annual Meeting held in December 2006 an interim analysis of the NCI's phase II study of romidepsin as a treatment for PTCL was presented. The interim results reported on 36 patients with PTCL. An overall response rate of 30% (11/36) was reported, with 3 complete responses (8%) and 8 partial responses (22%). The overall median duration of response has not yet been reached but was reported as being greater than 12 months. The most common adverse events reported were fatigue, nausea, and vomiting. About Fast Track Designation The Fast Track program is designed to facilitate and expedite the development and review of new products that demonstrate the potential to address an unmet medical need for serious or life-threatening conditions. A New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for a Fast Track product may be submitted in sections on a rolling basis, rather than simultaneously. Fast Track designation may further lead to a priority review of an NDA within a 6 month timeframe. About Special Protocol Assessment A Special Protocol Assessment is a request for feedback from the FDA that allows a company to receive official evaluation and guidance on the design and size of pivotal clinical trial protocols. A company can request this formal assessment on a pivotal trial that is intended to form the primary basis of an efficacy claim in a New Drug Application (NDA). About PTCL Peripheral T-cell lymphoma is a term which encompasses a number of different malignancies of T-cell origin that account for about 10-15% of all cases of non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma . PTCL can occur at any age from young adulthood to old age and is slightly more common in men than in women. It is a particularly aggressive form of lymphoma with a short median duration of life expectancy (approximately two years) from diagnosis. 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 Cutaneous T-Cell Lymphoma Definition Cutaneous T-cell lymphoma (CTCL) is a malignancy of the T-helper (CD4+) cells of the immune system. Description (CTCL CTCL Cutaneous T Cell Lymphoma ) and has initiated a pivotal phase II study for patients with peripheral T-cell lymphoma (PTCL). Romidepsin has received Orphan Drug Designation from the Food and Drug Administration (FDA) for the treatment of non-Hodgkin T-cell lymphomas, which includes CTCL and PTCL. In addition, the European Agency for the Evaluation of Medicinal Products (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. ) has issued Orphan Drug status for the treatment of both CTCL and PTCL. Fast Track status for CTCL and PTCL has also been designated by the FDA. Romidepsin is in clinical trials for a variety of other hematological 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 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 on Gloucester and our clinical development program visit our website at www.gloucesterpharma.com or call 888-474-2825. |
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