BHR Pharma has recently announced plans for a study to begin in early 2010. The study will be a multi-clinic trial to test the power and effectiveness of BHR-100, an intravenous progesterone infusion product, as an outcome-enhancing treatment option for patients with severe traumatic brain injury.
Currently, there are no FDA approved medications for use in improving the outcome for those suffering with traumatic brain injuries. The BHR Pharma study, if successful, will lead to the production and dissemination of the BHR-100 progesterone product as a neuroprotective substance for treating traumatic brain injury.
The study will span over 100 clinics in the U.S., Europe, Israel, and elsewhere about the globe, and will treat over 1200 traumatic brain injury patients. BHR-100 will be administered for 5 days to randomly selected patients with ‘severe closed head trauma‘ type traumatic brain injuries. BHR-100, unlike previous progesterone infusions, has been tailored to meet all U.S. Food and Drug Administration requirements for approval for use in humans.
BHR Pharma is cooperating with the American Brain Injury Consortium (ABIC) and the European Brain Injury Consortium (EBIC) to locate trial clinics and to help with the final design of the study. BHR has hired PRA International as a Contract Research Organization to assist in conducting the massive trial.
A Reuters article on the study described traumatic brain injury as, ‘a non-degenerative, non-congenital insult to the brain from an external mechanical force, possibly leading to permanent or temporary impairments of cognitive, physical and psychosocial functions with an associated diminished or altered state of consciousness.’
Most traumatic brain injuries happen during sporting and automobile accidents. Over 1.5 million Americans per year suffer from traumatic brain injuries. Over 50,000 of them lead to fatalities, while the vast majority of survivors suffer a wide spectrum of short and long-term symptoms, from loss of cognitive function to paralysis and coma.
Previous progesterone studies conducted by BHR Pharma showed promising results in the form of lower mortality rates and improved brain functionality following progesterone treatment. The company hopes that the new study will show even more exciting results and will lead to the release of BHR-100 for use in treating traumatic brain injuries around the world.
BHR Pharma holds the exclusive rights to patents on the use of progesterone-based drugs for use in treatment of traumatic brain injuries.
(pic from itech.dickinson.edu)