BHR Pharma (BHR) has reported that it will initiate phase 3, multi-center pivotal trial to evaluate the effectiveness of its proprietary BHR-100 intravenous progesterone infusion product as a neuroprotective agent for treating severe traumatic brain injury (TBI) patients in early 2010.
Reportedly, BHR will enroll approximately 1,200 patients with severe (Glasgow Coma Scale scores of 4-8), closed-head trauma TBI at 100-120 medical centers in the US, Europe, Israel and additional countries.
The company said that the randomised patients will receive a five-day intravenous infusion of progesterone or placebo.
Moreover, BHR is collaborating with the American Brain Injury Consortium (ABIC) and the European Brain Injury Consortium (EBIC) to identify the trial sites and help design the clinical study.
The SyNAPSe study will build on promising results achieved in several previous clinical trials that has demonstrated a mortality benefit and improved functional outcomes in TBI patients treated with progesterone.
BHR has exclusively licensed the rights to a patent family claiming the use of progesterone to treat traumatic brain injury, along with preclinical and clinical data from a phase 2 TBI study.