GeNO LLC Initiates Study of Inhaled NITROSYLâ„¢ Nitric Oxide in Idiopathic Pulmonary Fibrosis (PH-IPF) and Pulmonary Arterial Hypertension (PAH) Patients
COCOA, Fla., March 22, 2011 /PRNewswire/ -- GeNO LLC (www.genollc.com), a privately held, advanced development-stage technology company, today announced commencement of the PHiano Study: A Phase 2, Dose-Escalation Trial for the Treatment of Pulmonary Hypertension in patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension secondary to Idiopathic Pulmonary Fibrosis (PH-IPF) using Inhaled NITROSYL™ nitric oxide (NO). The first patient was successfully dosed at Creighton University Medical Center. This trial will be conducted at multiple clinical sites in the US, and is expected to enroll up to 75 patients. It is designed to investigate the safety and efficacy of various doses of inhaled nitric oxide (NO), up to a maximum of 80 ppm, delivered for up to 150 minutes with GeNO's stand-alone NITROSYL™ system in subjects with WHO Group 1 PAH and WHO Group 3 PH-IPF undergoing right heart catheterization (RHC).
The primary objective of the PHiano study is to identify the minimally effective dose and the maximum effective dose (dose beyond which no further effect on pulmonary vascular resistance is seen) of inhaled NITROSYL™ nitric oxide as compared to placebo. Secondary objectives include assessing the safety and tolerability of inhaled nitric oxide and evaluating the pharmacokinetics of total nitrates/nitrites and methemoglobin produced following inhalation. Additional study details can be found on http://clinicaltrials.gov/ ClinicalTrials.gov Identifier: NCT01265888.
GeNO's stand-alone gas cylinder stores premixed nitric oxide as nitrogen dioxide in either air or oxygen; however, this study will administer nitrogen dioxide only in air. The gas is allowed to flow through GeNO's proprietary cartridge containing ascorbic acid, which generates nitric oxide immediately prior to inhalation. A