NUVOX PHARMA, L.L.C. — Department of Health and Human Services SBIR Phase I: 101

Description

PROJECT SUMMARY ABSTRACT Clinical ChallengeIn acute traumain the civilian settinghemorrhage is the second most leading cause of deathIn the military settingof potentially preventable deaths are caused by hemorrhage due to traumaof civilian andof military mortality caused by traumatic hemorrhage occurs pre hospitalizationAdverse outcome in trauma patients during prehospital resuscitation is due to the unavailability of blood transfusions in the field leading to insufficient oxygenationTraumatic brain injuryTBIis the leading cause of disability in both civilians and militarySpecificallyin the pre hospital settinghypoxia in TBI may be the most important secondary injury affecting mortalityA therapy that can be deployed rapidlyand safely en route to the hospital in the civilian and the battlefield settings could greatly reduce the trauma mortality rates due to both hemorrhage and TBIWe are developing an oxygen therapeuticdodecafluoropentane emulsionDDFPewhich has the potential to be administered in the prehospital settingThis could greatly prolong the time window for administration of follow on therapies to trauma patientsthus increasing the likelihood of successful recoveryAll fluorocarbon emulsions undergo a gradual increase in particle size due to Ostwald ripeningDDFPe has a two year shelf life atCabout one year at room temperature and shorter shelf life at higher temperatures due to particle size increase beyond specificationsWe have discovered a means of maintaining the particle size of DDFPe within specification that affords at least a two year shelf life even under potentially extreme conditionsAvailability of an oxygen therapeutic in field conditions would allow it to be used in emergent settings maintaining vital oxygenation in civilian and military traumaOverarching HypothesesSonication of pre filled syringes of DDFPe can be employed to produce in spec nanoemulsion suitable for IV administrationUltimatelybattery poweredportableeasy to use pre filled syringe sonication systems can be developed for field based applicationsSpecific AimsDemonstration of optimal acoustic parametersDemonstration that product composition is not affected by sonicationExpected OutcomeSuccessful completion of the study will determine the optimal ultrasound parameters to enable design of a portablebattery powered syringe sonication device in Phase II of this development program A therapy that can be deployed rapidlyand safely en route to the hospital for civilians and also for soldiers on the battlefield could greatly reduce the trauma mortality rates due to both hemorrhage and traumatic brain injurySonication of pre filled syringes of dodecafluoropentane emulsionDDFPean oxygen therapeuticcan be employed to produce in spec nanoemulsion suitable for IV administrationUltimatelya battery poweredportableeasy to usepre filled syringe sonication system can be developed for DDFPe administration in the pre hospital setting