Gloucester Pharmaceuticals' Development of Romidepsin for Cutaneous T-Cell Lymphoma Continues Following Planned Review by Data Safety Monitoring Board.CAMBRIDGE, Mass. -- Gloucester Pharmaceuticals, Inc., an oncology focused biopharmaceutical company, today announced that following a planned safety review by an independent Data Safety Monitoring Board (DSMB DSMB Data & Safety Monitoring Board Clinical research A committee of independent clinical research experts who review data in ongoing clinical trials, ensuring that participants are not exposed to undue risk, and look for any differences in effectiveness ) of its pivotal trial of romidepsin as a treatment 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 ), the DSMB recommended that Gloucester continue the trial without any modifications. The DSMB had the same recommendation in each of three previous separate review meetings held in 2006. 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. 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 (CTCL) and has initiated a pivotal phase II study of romidepsin for patients with peripheral T-cell lymphoma (PTCL). Romidepsin has received Orphan Drug Designation from the 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. ) 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) has issued Orphan status for the treatment of both CTCL and PTCL. Fast Track status for CTCL has also been designated by the FDA. Romidepsin is in clinical trials for a variety of other hematologic 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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