SanFlow: A Therapeutic Agent for Use in the Field for Traumatic Brain Injury

We hypothesize that the use of SanFlow (aka polynitroxylated pegylated hemoglobin; PNPH) will ultimately translate to the reduction of mortality and morbidity, including post-traumatic stress disorder, from battle field traumatic brain injury (TBI). Towards that end, the present SBIR Phase 1 proposal will provide safety and efficacy results of SanFlow in a new guinea pig model of traumatic brain injury (TBI) with and without hemorrhagic shock (HS). Previous studies, all successful, were in mice. FDA in Pre-IND response has recognized SanFlow is a neuroprotective resuscitation agent for TBI and HS based on existing mouse data. The present study in a more advanced animal model with greater relevance to humans will set the stage for future Phase 2 studies in minipigs to be submitted at a later date. In mice, SanFlow is safe and efficacious at low unit volume as compared to fresh whole blood: peer reviewed publications have demonstrated SanFlow is efficacious at less than 1/10th the dose of shed fresh whole blood. The proposed safety and efficacy studies in guinea pigs will support IND and Phase I clinical trial protocol design for use of SanFlow as a neuroprotective agent for TBI with or without HS.