Study Evaluating Intravenous Progesterone Formulation BHR-100 Aims to Bring First-Ever Approved TBI Treatment to Market; Patient Enrollment Set to Complete in 2013
HERNDON, Va., April 15, 2013 /PRNewswire-USNewswire/ -- BHR Pharma, LLC announced today that the 1,000th patient has been enrolled in its SyNAPSe® clinical trial, a global phase III study evaluating the effectiveness of its proprietary intravenous progesterone infusion agent, BHR-100, to treat severe traumatic brain injury (TBI). BHR Pharma is sponsoring SyNAPSe with the intent to bring the first-ever approved TBI treatment to market.
This milestone patient was randomized at University of Louisville Clinical Research Center in Louisville, Ky., USA. The SyNAPSe trial currently has 154 participating sites, including U.S. Level 1 and 2 trauma centers, in 21 countries worldwide. Enrollment is expected to complete in 2013 with a target enrollment of 1,180 severe TBI patients.
"This is an exciting milestone for the SyNAPSe trial as we continue to develop this first-of-its kind treatment for a condition with no currently approved therapies," said Roland Gerritsen van der Hoop, M.D., Ph.D., BHR Pharma Chief Medical Officer and Head of Global Research and Development. "As we complete patient enrollment this year, we are one step closer to bringing BHR-100 to market, giving hope to TBI patients with few treatment options."
BHR-100 was granted Orphan Drug designation in Europe earlier this year and in the United States in 2009. In addition, the U.S. Food and Drug Administration placed the drug on Fast Track status designed to accelerate its potential approval. In January, BHR announced the trial's independent Data and Safety Monitoring Board (DSMB) interim analysis found no safety issues, indicating there was no reason to stop the study for futility and the trial could continue towards its intended completion.
Building on the promise of the SyNAPSe trial, BHR plans to initiate a phase I clinical trial for BHR-310, an intranasal progesterone powder, as a potential treatment for wounded warriors or athletes with TBI to be administered at the site of injury. Previous studies have shown the dry powder formulation to be highly efficient for targeting the brain, with very rapid absorption in the systemic circulation and even more so in the actual brain tissue.
About Traumatic Brain Injury (TBI)
TBI is a serious public health problem about 3.5 million Americans have a traumatic brain injury. Once a TBI occurs, medical treatment focuses on preventing further injury and promoting rehabilitation. TBI can have a debilitating impact on a person's life, and may require daily living assistance. Despite significant efforts and 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 in a TBI 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).
About BHR Pharma
Founded in January 2008, BHR Pharma, LLC (www.bhr-pharma.com) is a pharmaceutical research and development company located near Washington, D.C. 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 progesterone, estrogen and testosterone therapy products in 93 countries.
SOURCE BHR Pharma, LLC