GeNO LLC, Cocoa, Fla, has received approval from the US Food and Drug Administration (FDA) to begin clinical trials with the company’s NITROSYL™ (inhaled nitric oxide) System for the treatment of pulmonary hypertension in patients with pulmonary hypertension secondary to idiopathic pulmonary fibrosis (PH-IPF, WHO Group 3) and pulmonary arterial hypertension (PAH, WHO Group 1).
GeNO will conduct a US-based, multicenter, Phase 2 dose-escalation study in which both patient populations will receive up to a maximum of 80 ppm of nitric oxide delivered for up to 150 minutes with GeNO’s stand-alone NITROSYL platform.
The NITROSYL platform features a stand-alone gas cylinder that stores premixed nitric oxide as nitrogen dioxide in either air or oxygen. The gas is allowed to flow through a proprietary cartridge containing ascorbic acid, which generates nitric oxide immediately prior to inhalation. A second cartridge is provided for redundancy. The company has also developed the Ambulatory NITROSYL System, which is a hand-held unit with a disposable liquid source. The portable unit snaps into a small, battery-operated pump module attached to a hip or arm holster and provides up to a 4-day continuous supply of inhaled nitric oxide for chronic use.
Source: GeNO LLC