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BHR Pharma's SyNAPSe® Trial Reaches Important Enrollment Milestone on Brain Injury Awareness Day
Date:3/21/2012

n brain injury among athletes and military veterans, it can happen to anyone, anywhere and anytime – it happened to me as a result of a skateboarding accident," said Jacob Gebuhr, a brain injury survivor who was treated by Michael S. Turner, M.D. at the Goodman Campbell Brain and Spine in Indianapolis, IN and is currently a student at Purdue University. "Participating in the SyNAPSe® clinical trial gave my family and I hope during our most difficult time when we truly felt we had no options."

Building on promising results that suggest progesterone may help, BHR Pharma is conducting the only global Phase 3, multi-center trial for severe TBI designed to support worldwide regulatory submissions. There are more than 140 hospitals in 18 countries participating in the SyNAPSe clinical trial, with teams led by the top brain injury experts in the world.

The SyNAPSe study is evaluating the effectiveness of its proprietary BHR-100 intravenous progesterone infusion product as a neuroprotective treatment for patients that have sustained a severe blunt head injury. 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 with the intent of bringing an approved treatment to market.

About SyNAPSe®
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 started within eight hours of sustaining a TBI. The U.S. Food and Drug Administration has granted orphan drug status to BHR-100 and has placed the drug on a Fast Track Develop
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SOURCE BHR Pharma, LLC
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