Data Safety Monitoring Board Recommends Continuation of Gloucester Pharmaceuticals' Pivotal Trial for Depsipeptide in Cutaneous T-Cell Lymphoma; Second Favorable Recommendation from DSMB.CAMBRIDGE, Mass. -- Gloucester Pharmaceuticals, Inc., a privately held cancer therapeutics development company, announced today that 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 ) has reviewed interim safety data in its international pivotal trial evaluating the Company's depsipeptide product as a treatment 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 (CTCL CTCL Cutaneous T Cell Lymphoma ). The DSMB recommended that Gloucester continue the trial without any modifications. The DSMB had previously recommended continuation of the trial when it met in January 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. Gloucester's pivotal clinical CTCL trial is a Phase II, non-randomized, open label, single arm study that is being conducted at approximately 20 sites in the US and Europe. 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 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 cutaneous T-cell lymphoma patients who have relapsed, or become refractory to, at least one prior systemic therapy. Depsipeptide is also in clinical 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-GPI-CTCL (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. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion