Texas Tech University Health Sciences Center and University Medical Center Continue to Forge Ahead with Clinical Trial

Every 19 seconds someone is treated in an emergency room for a traumatic brain injury (TBI). Every 10 minutes one of those patients dies.

Despite the fact that emergency departments treat TBIs more frequently than heart attack and stroke patients, there are currently no approved medications to improve outcomes following a TBI.

“Traumatic brain injuries are the leading cause of death and disability among young Americans and have become known as the ‘signature wound’ of the wars in Iraq and Afghanistan,” said Congressman Todd Platts (PA-19), co-chair of the Congressional Brain Injury Task Force. “Making progress on this critical issue will require concerted efforts in Congress to expand access to treatments in a fiscally responsible manner, as well as expanded research in the private sector to help find treatments for this debilitating condition.”

Most TBI victims will survive, but the consequences of the injury are unpredictable. TTUHSC and University Medical Center, with Principal Investigator Ahmed Badr, M.D., professor of neurosurgery, and Co-Investigators Alan Tyroch, M.D., professor of surgery, and Fadi Hanbali, M.D., associate professor of neurosurgery, are participating in SyNAPSe, a global Phase 3, multi-center trial (www.SyNAPSe-trial.com) sponsored by BHR Pharma to evaluate the effectiveness of its proprietary BHR-100 intravenous progesterone infusion product as a neuroprotective agent for treating severe TBI patients. Patients must meet certain eligibility criteria in order to participate in the study. The therapy must be delivered within eight hours of sustaining a TBI.

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. Moreover, SyNAPSe is the only pivotal trial with progesterone for TBI designed for global regulatory approval.

The U.S. Food and Drug Administration 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.

“Our hope with the SyNAPSe trial is to demonstrate that progesterone can dramatically alter the outcome for TBI patients and result in an approved product,” said Tom MacAllister, CEO of BHR. “We have worked with both the American Brain Injury Consortium and the European Brain Injury Consortium to design the trial for success, but success will ultimately depend on the help of our medical center partners in enrolling patients in the trial.”

The SyNAPSe trial will enroll approximately 1,200 patients with severe TBI (Glasgow Coma Scale scores of 4-8), and who have sustained a closed-head trauma, at more than 100 trauma centers in the U.S., Europe, Israel and additional countries. The trial started in July 2010 and the first patient was enrolled at the University of Pittsburgh Medical Center.