Aires Pharmaceuticals signs license agreement with NIH

Aires Pharmaceuticals Inc. today announced the signing of an exclusive license agreement with the U.S. National Institutes of Health for the patented use of a nitric oxide prodrug to treat cardiopulmonary conditions.

The technology, identified at the NIH's National Heart, Blood and Lung Institute, shows that nitrite, which is converted by the body into nitric oxide, can be delivered as an effective treatment for pulmonary hypertension, myocardial infarction, transplantation and cerebral vasospasm. Aires Pharmaceuticals is developing Aironite(TM), a proprietary, inhalable formulation of nitrite, to treat pulmonary arterial hypertension (PAH). The company has Orphan Drug Status from the U.S. Food and Drug Administration and has completed its first Phase I clinical trial for this indication.

"We are pleased to have concluded this important agreement," said Wendy Johnson, President and CEO of Aires Pharmaceuticals. "We are aggressively gearing up to evaluate our product in patients with pulmonary arterial hypertension."

Pulmonary hypertension is an under-diagnosed disease, with an estimated prevalence of 100,000 patients in the U.S. Approximately 16,000 patients are currently being treated. It is characterized by narrowing of the arteries of the lung resulting in difficulty breathing during exertion. Heart failure results as the condition worsens. While there is no cure for the disease, current treatments can extend the lives of patients five to seven years. "Drug therapy has been shown to improve survival and PAH patient quality of life," stated Dr. Lewis Rubin, Professor of Medicine at the University of California, San Diego. "Aironite holds great promise due to its unique mechanism of action, and pulmonary specific activity." Dr. Rubin serves as Aires' Chief Medical Officer.

Aironite is aerosolized nitrate in a sustained release formulation that delivers the drug to the areas of the lung and heart experiencing reduced oxygen and blood flow. Under these conditions, Aironite is converted to nitric oxide, a substance with several beneficial properties, including dilation of blood vessels and a reduction of inflammation and undesirable cell growth.

The research and technology for this treatment was identified in the laboratory of Dr. Mark Gladwin, formerly chief of the Pulmonary and Vascular Medicine Branch of the National Heart, Blood and Lung Institute, and colleagues from other U.S. universities. Dr. Gladwin is now at the University of Pittsburgh Medical Center where he is the Chief of the Division of Pulmonary, Allergy and Critical Care Medicine and Director of the Hemostasis and Vascular Biology Research Institute.