Hydrocarbon aspiration, a frequent pediatric poisoning, may produce life-threatening pulmonary hypertension. Current treatment regimens to reduce pulmonary blood pressure are cumbersome, expensive, and involve potential toxic exposure to health care personnel. The recent development of a novel class of selective pulmonary vasodilators (polar NONOATEs) promises to revolutionize the treatment of pulmonary hypertension secondary to hydrocarbon aspiration. Inotek now proposes to establish proof-of-principle utilizing a large animal model of hydrocarbon aspiration. Upon confirmation that polar NONOATEs reverse pulmonary hypertension in this stringent and clinically relevant experimental model, Inotek intends to apply for Phase 2 SBIR funding to support formal toxicology studies and a Phase I FDA-regulated clinical trial.
The annual incidence of hydrocarbon aspiration in the United States is estimated at 30-50,000 patients. An effective, inexpensive, and safe therapy for pulmonary hypertension would command a unit price of 1000 dollars, for a typical clinical course of 1 week. Accordingly, a 30-50 million annual domestic market is anticipated. World-wide income would be approximately four times the domestic market.
