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New Pre-Clinical and Clinical Data on GeNO LLC's Nitric Oxide Delivery Systems to be Presented at 2013 American College of Cardiology and American Thoracic Society Medical Meetings


1/29/2013 9:24:25 AM

WALTHAM, Mass., Jan. 29, 2013 /PRNewswire/ -- GeNO LLC (www.genollc.com), a privately held pharmaceutical company developing a line of innovative nitric oxide drug products, today announced that new pre-clinical and clinical data from studies of GeNO's nitric oxide delivery systems will be presented at the American College of Cardiology's Annual Scientific Session in March 2013, and at the American Thoracic Society International Conference in May 2013.

GeNO's preclinical and clinical data will be included in the following presentations:

"Nitric Oxide Treatment of Right Ventricular (RV) Failure Associated with the Use of a Left Ventricular Assist Device (LVAD) and Hypoxemia-induced Pulmonary Hypertension" will be presented at the American College of Cardiology 62nd Annual Scientific Session in San Francisco, CA on March 11, 2013. The presentation will include pre-clinical data from a study showing GeNO's inhaled nitric oxide delivery system decreased pulmonary vascular resistance (PVR) and RV distension, increased RV ejection, and increased the maximum achievable LVAD speed and flow in a mammal model with LVAD associated RV failure and hypoxemia induced pulmonary hypertension.

"Ambulatory System for the Delivery of Nitric Oxide (NO) Derived from Liquid Dinitrogen Tetroxide (N2O4)" will be presented at the American Thoracic Society International Conference in Philadelphia, PA on May 20, 2013. This pre-clinical data shows a novel approach for the delivery of inhaled nitric oxide to a mammal that, for the first time, uses a small volume of liquid rather than cylinders of compressed gas. The delivery system relies on evaporation of liquid N2O4 into NO2 gas, which is then reduced to ultrapure nitric oxide just prior to inhalation, using GeNO's proprietary cartridge technology. These experiments demonstrate that nitric oxide derived from liquid N2O4 is equally efficacious as nitric oxide derived from NO2 gas in lowering mean pulmonary arterial pressure (mPAP) and PVR in a mammal. The amount of nitric oxide generated with 0.2 ml of N2O4 is enough to deliver nitric oxide for >24 hours at flow rates used for nasal cannula delivery systems.

"A Phase 2 Open Label Pilot Study Evaluating Preliminary Safety and Performance of the GeNO Nitrosyl Delivery System" will be presented at the American Thoracic Society International Conference in Philadelphia, PA on May 20, 2013. This is the first clinical study to demonstrate that inhaled nitric oxide can be delivered in adult pulmonary arterial hypertension (PAH) patients with GeNO's inhaled nitric oxide delivery system in combination with approved PAH therapies with expected selective acute pulmonary hemodynamic effects.

"The data to be presented at these meetings provide important new insights into the clinical utility of ultrapure, inhaled nitric oxide delivered by GeNO's nitric oxide delivery system," said Dr. David Fine, Chief Executive Officer, GeNO LLC.

Dr. Robert Roscigno, Executive Vice President of Clinical Development, GeNO LLC, stressed that "as we advance this investigational product into late stage clinical trials for various forms of Pulmonary Hypertension, additional therapeutic options are still needed. These data support further clinical development of GeNO's technologies for use by patients in need of acute and chronic Pulmonary Hypertension therapies."

In 2012, GeNO announced that its New Drug Application (NDA) for the GeNOsyl MVG-2000 Nitric Oxide Delivery System for neonates with hypoxic respiratory failure had been accepted for filing by the U.S. Food and Drug Administration (FDA). 510(k) clearance was also granted earlier that year for GeNO's MV-1000 Inhaled Nitric Oxide Delivery System, as well as orphan drug designation for the nitric oxide delivered by the GeNOsyl MVG-2000 Delivery System for the treatment of persistent pulmonary hypertension in newborns.

GeNO is developing three unique nitric oxide delivery platforms for hospital and outpatient use. Each of the platforms is designed to deliver ultrapure nitric oxide with extremely low levels of nitrogen dioxide, an impurity known to pose serious health risks. These platforms also address the cost, complexity and lack of portability of currently approved inhaled nitric oxide treatment systems. GeNO'snitric oxide gas has the potential for use in the treatment of a multitude of serious pulmonary and cardiac diseases, and potentially could reach a much larger group of patients than the currently approved alternatives.

GeNO has completed a Phase 2 pilot study of its nitric oxide for use as a diagnostic in Pulmonary Arterial Hypertension (PAH) and is currently performing a dose-escalation trial for the treatment of Pulmonary Hypertension in patients with PAH and Pulmonary Hypertension secondary to Idiopathic Pulmonary Fibrosis (PH-IPF). Additional study details can be found on http://clinicaltrials.gov/-- ClinicalTrials.gov Identifier NCT01265888. Other than the 510(k) clearance of GeNO's MV-1000 nitric oxide delivery system, GeNO's nitric oxide delivery technologies are investigational and are not approved by regulatory authorities.

ABOUT GENO LLC
GeNO LLC, founded in 2006, is a privately held pharmaceutical company that is developing innovative nitric oxide generation and delivery chemistry and platforms to enable the true potential of inhaled nitric oxide to be realized for the treatment of a multitude of diseases. The company is focused on applying its technology to delivering inhaled nitric oxide to patients in a variety of settings, including ambulatory and in-home use for potential chronic treatment. GeNO will provide stand-alone medical devices and combination products that include the base delivery system and GeNO's nitric oxide gas. GeNO's systems have been designated as Combination Products by the FDA Office of Combination Products, with the Division of Cardiovascular and Renal Products designated as the lead reviewer for GeNO's initial INDs. The combination products will be regulated by the FDA as new drugs with their own NDAs.

Media Contacts:

Kellie Caldwell
610-505-1511
kelliemcaldwell@gmail.com

Brian Heffron
781-799-9568
bheffron@ctpboston.com

SOURCE GeNO LLC



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