GeNO LLC, Cocoa, Fla, announced the commencement of the PHiano Study: A phase two, dose-escalation trial for the treatment of pulmonary hypertension (PH) in patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension secondary to idiopathic pulmonary fibrosis (PH-IPF) using inhaled NITROSYL™ nitric oxide (NO). The trial will be conducted at multiple clinical sites in the United States, and is expected to enroll up to 75 patients. It is designed to investigate the safety and efficacy of various doses of inhaled 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.
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 NO 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.
Results from this study will provide information necessary to design a phase two/three study for chronic ambulatory administration of NO, according to GeNO’s founder and president David Fine, PhD. who added that the combined results from the studies will help to define responses in both populations and further guide future development."
No medications are currently approved for treatment of PH associated with IPF, which is characterized by progressive fibrosis in the lungs with a median survival time from diagnosis of 2 to 5 years and a 5-year survival rate of approximately 20%. Pulmonary arterial hypertension 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 5 years.
Source: GeNO LLC