HERNDON, Va., Sept. 7, 2011 /PRNewswire/ -- BHR Pharma, LLC (BHR) has now enrolled 200 patients in the SyNAPSe® Phase 3 clinical trial of progesterone for traumatic brain injury (TBI). This milestone gives SyNAPSe half the number of enrolled patients required for the important interim analysis planned at 400 patients.
"Through this study, we hope to dramatically change the lives of victims of severe TBI. This milestone puts us one step closer to that goal," said Dr. Tom MacAllister, CEO of BHR. "I want to thank all the investigators and researchers who have helped us get here. We remain focused on finding a treatment for this unmet need."
An estimated 1.7 million Americans per year suffer a TBI, resulting in 52,000 deaths, 275,000 hospitalizations and 80,000 cases of long-term disability. There are currently no treatments available to stop the progression of the disease. SyNAPSe is the only pivotal trial with progesterone for TBI designed for global regulatory approval.
"Traumatic brain injury is best known because of sports-related concussions, but there is an untold story here," said Dr. MacAllister. "The 200 subjects in our study include victims of automobile crashes, domestic abuse and other accidents that have left them permanently disabled."
In June, BHR Pharma's Data and Safety Monitoring Board (DSMB) reviewed safety and efficacy data on the first 100 subjects in the trial. The board found no safety concerns and concluded that the trial should continue.
The SyNAPSe trial will enroll approximately 1,200 patients with severe TBI (Glasgow Coma Scale scores of 4-8), who have sustained a closed-head trauma. There are currently more than 100 participating trauma centers in 16 countries, with plans to open centers in up to five more countries later this year.
Previous clinical trials, conducted in the U.S. and China, suggest that progesterone can improve outcomes for TBI victims. Both studies showed about a 50 percent lower mortality in the progesterone-treated group as compared to placebo. The Chinese study also showed a statistically significant functional improvement and the U.S. study showed a similar trend. The SyNAPSe trial is designed to build on these promising results with the intent of bringing an approved treatment to market.
BHR is conducting a global Phase 3, multi-center trial to evaluate the effectiveness of its proprietary BHR-100 intravenous progesterone infusion product as a neuroprotective agent for treating severe TBI patients. The therapy must be delivered within eight hours of sustaining a TBI.
The U.S. Food and Drug Administration (FDA) has granted orphan drug status to BHR-100 and has placed the drug on a Fast Track Development Program designed to accelerate its potential approval. They also agreed to approve BHR-100 based solely on the outcome of SyNAPSe if it meets certain objectives, something very uncommon. For information visit www.SyNAPSe-trial.com.
Founded in January 2008, BHR Pharma, LLC (www.bhr-pharma.com) is a pharmaceutical research and development (R&D) 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, LLC