Updated on 13 June 2012
Traumatic brain injury trials to be held in Thailand, China and Russia
Singapore: BHR Pharma has started recruiting patients, who are suffering from severe traumatic brain injury (TBI), for their SyNAPSe clinical trial at 14 sites in Thailand, China and Russia. Gloabally, the trial presently has 153 participating sites, including level 1 and 2 trauma centers.
The SyNAPSe clinical trial is evaluating the effectiveness of BHR-100, which is a proprietary intravenous progesterone infusion formulation, as a neuroprotective agent for treating severe TBI patients. The US FDA had granted orphan drug designation to BHR-100 and have placed the drug on a fast track status in order to accelerate its potential approval.
Dr Thomas W MacAllister, president & CEO, BHR Pharma, said that, "In the past four months we've added 28 clinical trial sites, including additional centers in the US and Europe, and we're working towards opening six Malaysian sites in the near future. We're on track to complete enrollment for this pivotal clinical trial early next year, with the intent of bringing the first-ever treatment for TBI to market."
Building on the SyNAPSe study of BHR-100 and promising research conducted by Emory University, BHR is also developing BHR-310, an intranasal progesterone powder. This nasal spray is being evaluated as a potential treatment that can be administered to wounded warriors or athletes with TBI quickly after injury on the battlefield or playing field.