New Data Shows GeNO LLC Nitric Oxide Delivery System Provided Nitric Oxide With Low Levels of Nitrogen Dioxide for Heart Transplant Patient Evaluation
SAFETY RESULTS for NITROSYL COULD SIGNAL BROADER TESTING IN CARDIO-PULMONARY DISEASE
19 Apr, 2012, 11:00 ET
COCOA, Fla., April 19, 2012 /PRNewswire/ -- New data presented today studied the safety of the GeNO system for delivering inhaled nitric oxide (NO) to patients being evaluated for cardiac transplant. GeNO LLC (www.genollc.com), a privately held, advanced development-stage technology company, announced that a study of GeNO's NITROSYL Delivery System during Right Heart Catheterization (RHC) in subjects being evaluated for Orthotopic Heart Transplantation (OHT) and Left Ventricular Assist Device (LVAD) implantation was presented at the International Society for Heart & Lung Transplantation (ISHLT) Annual Meeting in Prague, Czech Republic.
The study was led by Dr. Andrew Boyle, Medical Director of Heart Failure, Cardiac Transplantation and Mechanical Circulatory Support at Aurora St. Luke's Medical Center in Milwaukee, and evaluated 10 heart failure patients who underwent RHC prior to cardiac transplant or LVAD implant.
GeNO's NITROSYL Delivery System was used to deliver NO at a concentration of 80 PPM for 15 minutes by nasal cannula with air or O2. Results showed that in eight patients who received NO in air, the levels of nitrogen dioxide (NO2) in the gas that was delivered varied from 0.04 PPM to 0.06 PPM. Two patients received NO in O2 with NO2 levels in the gas varying from 0.25 to 0.35 PPM. Device performance was evaluated by measuring the amount of NO2 delivered to the patients as monitored by cavity attenuated phase-shift spectroscopy (CAPS) which can accurately detect NO2 down to 0.006 PPM. Cardiac hemodynamics were measured prior to and following 15 minutes of NO exposure. Clinically meaningful hemodynamic changes were not seen after such a short exposure to NO including PAP, PCWP, CO, CI, and PVR.
"The GeNO device reproducibly provided NO with low levels of NO2 in air or O2. The NO2 levels were considerably below the FDA limit of 3 PPM and OSHA limit of 5 PPM even in the presence of oxygen which is known to convert NO to NO2 rapidly," said lead author Dr. Boyle. "These promising preliminary safety findings, combined with an improved ease of delivery compared with commercially available devices, justify a larger efficacy trial with longer exposure to the device in patients with pulmonary hypertension."
The primary aim of the study was to evaluate the safety, tolerability and device performance of the GeNO NITROSYL Delivery System during RHC. Secondary considerations were to confirm that inhaled NO generated by the system reduces pulmonary vascular resistance (PVR) in patients with reversible pulmonary hypertension and contains levels of NO2 well below the upper level of acceptable exposure. The study title is "An Open Label Non-Randomized Pilot Study To Evaluate the Safety of the GeNO NITROSYL Delivery System in Patients Being Evaluated for Heart Transplantation."
This is the first human data to be presented with the Company's novel NO delivery system that converts nitrogen dioxide in either balance air or oxygen to nitric oxide. The gas is allowed to flow through a proprietary cartridge containing ascorbic acid, which generates nitric oxide immediately prior to inhalation. A second cartridge is provided for redundancy.
"We are pleased to see these study results, as the purity of nitric oxide produced by our unique technology will be of interest to many health care professionals who use NO to treat a variety of life threatening conditions and diseases," said GeNO LLC Founder and President David Fine. "We remain committed to moving both our in-hospital solution and our ambulatory system through clinical development."
GeNO's NITROSYL Delivery System could add valuable options for clinicians treating a range of serious pulmonary and cardiac diseases with inhaled nitric oxide. GeNO's plans for both in-hospital and ambulatory inhaled nitric oxide systems will help address the cost, complexity and lack of portability of current treatment regimens, and potentially reach a much larger group of patients. At present, GeNO's delivery technologies are investigational and are not approved by regulatory authorities.
GeNO recently completed a 10 patient Phase 2 pilot study of NITROSYL as a diagnostic in Pulmonary Arterial Hypertension (PAH) to obtain preliminary safety and feasibility data 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.
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 true 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. These 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.
ABOUT AURORA HEALTH CARE
Aurora Health Care is a not-for-profit Wisconsin based health care provider and a national leader in efforts to improve the quality of care. Aurora provides care at sites in more than 90 communities throughout eastern Wisconsin and northern Illinois.
Carla Burigatto, 610-457-2178
Brian Heffron, 781-799-9568
SOURCE GeNO LLC
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