HERNDON, Va., June 12, 2012 /PRNewswire/ -- BHR Pharma's SyNAPSe® clinical trial is now enrolling patients suffering from severe traumatic brain injury (TBI) at 14 sites in Thailand, China and Russia. The trial currently has 153 participating sites (Level 1 and 2 trauma centers) worldwide.
The 500th of 1,180 patients needed to complete the global Phase III, multi-center trial was enrolled at the end of May in the United States.
SyNAPSe is evaluating the effectiveness of BHR-100, a proprietary intravenous progesterone infusion formulation, as a neuroprotective agent for treating severe TBI patients. The U.S. Food and Drug Administration had granted Orphan Drug designation to BHR-100 and have placed the drug on a Fast Track status designed to accelerate its potential approval.
"In the past four months we've added 28 clinical trial sites, including additional centers in the United States and Europe, and we're working towards opening six Malaysian sites in the near future," said Thomas W. MacAllister, JD, PhD, President & CEO of BHR Pharma. "We're on track to complete enrollment for this pivotal clinical trial early next year, with the intent of bringing the first-ever treatment for TBI to market."
TBI is a serious public health problem that affects more than 1.7 million Americans each year. Despite significant efforts in more than 75 clinical trials over the past 20 years, there is still no approved treatment for TBI.
Previous research has shown progesterone exerts its neuroprotective effects by protecting or rebuilding the blood-brain barrier, decreasing development of cerebral edema (brain swelling), down-regulating the inflammatory cascade and limiting cellular necrosis and apoptosis (programmed cell death).
"Unfortunately, little can be done to reverse the initial brain damage caused by a TBI. Once a TBI occurs, medical treatment focuses on preventing further injury and promoting rehabilitation," said Dr. MacAllister. "BHR-100 is designed to protect brain cells from dying right after the injury, which may facilitate outcomes previously not thought to be possible."
Building on the SyNAPSe study of BHR-100 and promising research conducted by Emory University, BHR is also developing BHR-310, an intranasal progesterone powder. This nasal spray is being evaluated as a potential treatment that can be administered to wounded warriors or athletes with TBI quickly after injury on the battlefield or playing field. Preclinical studies of BHR-310 in rats and monkeys support the feasibility of a high-dose, rapidly absorbed intranasal progesterone product able to deliver clinically meaningful doses of progesterone to the brain.
About BHR Pharma
Founded in January 2008, BHR Pharma, LLC (www.bhr-pharma.com) is a pharmaceutical research and development company located near Washington, DC. BHR is committed to bringing to market specialty treatments that employ non-oral delivery systems, with an emphasis on unmet and underserved medical needs. The company is a wholly owned subsidiary of Besins Healthcare SA (www.besins-healthcare.com), which markets healthcare products in 93 countries.
SOURCE BHR Pharma