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BHR Pharma Enrolls First Patient in Phase 3 SyNAPSe Traumatic Brain Injury Trial
Date:7/23/2010

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"This drug has the potential to help a gravely ill population that includes car crash and battlefield injuries and we could not be more pleased to initiate this important trial," said Tom MacAllister, J.D., Ph.D., BHR president and CEO.  "The annual incidence of TBI is higher than breast cancer and HIV/AIDS combined, yet it is largely ignored.  We are proud to lead the efforts to make a difference for these patients and their families."

The leading cause of death and disability in children and young adults worldwide, TBI is involved in nearly half of all trauma deaths.  Traffic accidents account for 40-50 percent of the hospitalizations related to the condition.

BHR was notified in June that the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research had completed its special protocol review and the SyNAPSe trial design and planned analysis adequately address the objectives necessary to support a regulatory submission.  Under the FDA Special Protocol Agreement, BHR will be able to seek marketing approval of BHR-100 without additional pivotal trials, provided the SyNAPSe study results meet specific statistical significance targets and other measures.  The trial is posted on www.clinicaltrials.gov.

Last December, BHR announced that its product had been granted orphan drug status by the FDA Office of Orphan Products Development for early intervention in the treatment of moderate-to-severe closed-head TBI.  The FDA only designates orphan-drug status on novel drugs or biologics that treat a rare disease or condition affecting less than 200,000 A
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SOURCE BHR Pharma, LLC
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