Virtech Bio, Inc. — Department of Defense SBIR Phase II: SOCOM172-002

Description

Currently, there is no resuscitation fluid with oxygen carrier and plasma expansion capabilities to treat hemorrhagic shock in combat canines. Under SOCOM SBIR Phase 1, VirTech Bio developed a new hemoglobin-based oxygen carrier, VIR-VET, and performed successful feasibility safety and efficacy tests in rat models. In those studies, VIR-VET demonstrated prolonged vascular retention, without adverse hemodynamic effects, and longer survival times in a hemorrhagic shock model. In Phase 2, Technical Issues will be addressed under four Tasks: 1) Finalize processing of the prototype VIR-VET to be used for stability studies in accordance with FDA guidelines and for use in pre-clinical tests. 2) Acute toxicity studies will be performed in vivo in canines. 3) Experimental mechanism of action studies, based on preliminary Phase 1 studies in rats, will be assessed in a PK study to evaluate circulating half-life in canines and a hemorrhage and resuscitation model in canines using the pre-clinical grade material. Efficacy will be evaluated in canines through measures of oxygen transport and survivability in the hemorrhagic shock model. The hemorrhagic shock model is designed to mimic battlefield treatment of canine hemorrhage before hospital care is available.