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GeNO LLC Initiates Study of Inhaled NITROSYL™ Nitric Oxide in Idiopathic Pulmonary Fibrosis (PH-IPF) and Pulmonary Arterial Hypertension (PAH) Patients
Date:3/22/2011

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 second cartridge is provided for redundancy.  

"Results from this study will provide information necessary to design a Phase 2/3 study for chronic ambulatory administration of nitric oxide," said GeNO LLC Founder and President David Fine, Ph.D.  "The combined results from this current Phase 2 study and planned Phase 2/3 chronic study will help to define responses in both populations and further guide Phase 3 development."

"Our Phase 2 program will assess whether nitric oxide improves pulmonary hypertension in both populations, whether there are safety concerns in either group that are unique to that condition (or background treatment) or shared by both, and whether the profile of effect is common," added GeNO Vice President Robert F. Roscigno, Ph.D.  "While IPF and PAH are different, GeNO will focus on the one common feature, the pulmonary hypertension, which is a determinant of survival and at least an element or cause of symptoms."

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 percent.  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.  

The next version of GeNO's platform to enter the clinic later this year will be the GeNO Ambulatory NITROSYL™ System, which is a hand-held unit with a disposable liquid source.  This portable unit snaps into a small, battery operated pump module attaching to a hip or arm holster and provides up to a 4-day continuous supply of inhaled nitric oxide for chronic use.

In December 2010, GeNO initiated its first clinical study, a 10 patient Pilot Study to obtain preliminary safety and feasibility data from short term (15 minute) administration of inhaled nitric oxide via the GeNO Nitrosyl delivery system.  Additional study details can be found on http://clinicaltrials.gov/ ClinicalTrials.gov Identifier: NCT01092559.

"This trial has provided important information regarding preliminary safety and feasibility data from short term (15 minute) administration of inhaled NITROSYL™ nitric oxide," said Fine. "We are pleased with the performance of the system and to date, no adverse events (AEs), or unanticipated adverse device effects (UADE's) have been reported."

With the diagnostic trial ongoing, today's Phase 2 PHiano study will help GeNO establish the optimal dose for further product development (including the ambulatory system), and helps GeNO prepare to move from a diagnostic to a treatment setting.

ABOUT GeNO LLC GeNO LLC, founded in 2006, is a privately held, advanced development-stage technology company that is developing innovative nitric oxide (NO) generation and delivery platforms to enable the broad potential of inhaled nitric oxide to be realized. The company is focused on applying the new technology to deliver inhaled nitric oxide to patients in a wide variety of settings, including ambulatory and in-home use for potential chronic treatment. GeNO's NITROSYL™ Systems will be regulated by the FDA as new drugs with their own NDAs. GeNO plans to submit an IND to FDA later this year to begin evaluation of the GeNO Ambulatory NITROSYL™ System. The company has five US patents with additional patent applications pending. Media Contacts: Carla Burigatto, 610-457-2178

Brian Heffron, 781-799-9568cburigatto@gmail.com

bheffron@ctpboston.com
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SOURCE GeNO LLC
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