Topic 369: DRUG DELIVERY SYSTEM TO SAVE HEARING DURING PEDIATRIC CHEMOTHERAPY REGIMENS

Our company has invented a magnetic drug delivery device that we intend to develop to enable prevention of a major side effect of chemotherapy in children. Cisplatin and carboplatin chemotherapy regimens can lead to severe hearing loss, especially in pediatric patients. For cisplatin, hearing loss is FDA listed on-label as a dose limiting toxicity. Hearing loss in kids has a dramatic impact on their ability to communicate and learn and is associated with substantial cognitive and speech development deficits. Our drug delivery technology enables topical delivery of otoprotective therapy to the cochlea, and in animal studies has been shown to save hearing from cisplatin regimens. Topical and non-invasive magnetic delivery of a small dose of otoprotective steroid to the cochlea would not interrupt the systemic anti-tumor action of chemotherapy, and in some patients would remove limits on administering needed chemo doses due to induced severe hearing loss. Funding support shall be used to progress our delivery system through FDA milestones, so it can reach patients.