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.
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