COCOA, Fla., Nov. 2, 2010 /PRNewswire/ -- GeNO LLC (www.genollc.com) a privately held, advanced development-stage technology company announced today that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for the GeNO NITROsyl (Inhaled Nitric Oxide) System for the treatment of pulmonary hypertension in patients with pulmonary arterial hypertension (PAH) and in patients with pulmonary hypertension secondary to idiopathic pulmonary fibrosis (PH-IPF). If accepted, the IND will enable GeNO to begin a Phase 2 dose escalation study in which both patient populations will receive up to a maximum of 80 ppm NO delivered for up to 150 minutes with its stand-alone NITROsyl platform.
Pulmonary arterial hypertension (PAH) is a rare progressive disorder that carries a poor prognosis and is associated with significant morbidity and mortality, having an historical survival rate rarely exceeding five years.
In contrast to PAH, no medications are currently approved for treatment of pulmonary hypertension (PH) associated with idiopathic pulmonary fibrosis (IPF). IPF is characterized by progressive fibrosis in the lungs with a median survival time from diagnosis of two to five years and a five-year survival rate of approximately 20%. There is a significant unmet medical need in this patient population for a potent and selective pulmonary vasodilator that can reduce pulmonary arterial pressure (PAP) and pulmonary vascular resistance (PVR) and improve oxygenation.
"The submission of this IND is a major milestone for the company," said GeNO's founder and president, David Fine, Ph.D. "We have worked hard to develop an approach of delivering inhaled Nitric Oxide therapy as an efficient and effective treatment to chronic illness."
Following the dose escalation study, it is planned to study these two populations for 12 weeks in a multicente