Drug Delivery Method for Sudden Sensorineural Hearing Loss

Project Summary Abstract The ultimate goal of the proposed project is to evaluate and commercialize a combination of proprietary magnet assemblies and magnetic nanoparticles that has been shown in small animal and cadaveric large animal and human studies to improve delivery of medications to the inner earStudies using the systemwhich uses magnetic forces to inject drug eluting magnetic nano particles into the inner earhave successfully reduced the degree of hearing loss and tinnitus in rats due to acoustic traumaand have conferred hearing protection against chemotherapy regimens in miceThe amount of drug reaching the inner ear was increased ten fold and the drug distribution uniformity was increased three foldas compared to the current standard of trans tympanic injection into the middle earOur strategy is to demonstrate the utility of the magnetic injection system as a platform technology addressing the $billion hearing marketstarting with a compelling orphan indicationsudden sensorineural hearing lossthat is currently without a cure and is considered an otologic emergencySubsequentlywe shall address other cochlear conditions such as tinnitus and protection of hearing during chemotherapy regimens that are also not adequately addressed by the current standards of careThe FDA recommends testing in at least two mammalian speciesthe second of which should be a non rodent mammal before entry into human trialsBased on successful Phaseresults in rodentsand on reviewer suggestionsin Phasewe shall conduct large animal testing in sheepSheep are recognized to have a similar ear anatomy and hearing as compared to humansand a common animal model submitted to the FDAWe aim toAimSelect sheep noise trauma conditions based on previously published dataAimSelect dose and show therapeutic effect for noise trauma induced hearing loss in sheepAimConduct a detailed safety and toxicology study in healthyno noise traumasheepWe anticipate that smallPhaseand large animalPhasesafety and therapeutic effect data in animals will support an INDInvestigational New Drugfiling to the FDAApproval of an IND by the FDA is required to allow entry into human clinical trials Project Narrative Our overall goal is to improve treatment outcomes for patients with sudden hearing lossand other conditions of the cochleausing a proprietary drug delivery systemMagnetic injection will be used to minimally invasively deliver drugs to the inner earto improve drug concentration and uniformity and thus therapeutic effect