Adult Respiratory Distress Syndrome (ARDS) is a major cause of morbidity and mortality after trauma and infection. ARDS is often complicated by pulmonary hypertension, a life-threatening condition which produces hypoxemia and heart failure. 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 ARDS. Inotek now proposes to establish proof- of-principle utilizing a porcine model of oliec acid-induced ARDS. 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 ARDS in the United States is estimated at 200,000 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 200 million dollar annual domestic market is anticipated. World-wide income would be approximately four times the domestic market.
