GeNO LLC Receives Federal Grant To Advance Studies of Inhaled Nitric Oxide Product for the Treatment of Chronic Pulmonary Diseases
NIH Awards Company a Phase 1 Small Business Innovation Research Grant
COCOA, Fla., Aug. 23, 2011 /PRNewswire/ -- GeNO LLC, (www.genollc.com) a privately held, advanced development-stage technology company, today announced that it has received a new federal grant to help fund the development of its NITROSYL™ (Nitric Oxide for Inhalation) System for the treatment of multiple chronic pulmonary diseases. Last year, the company also received a US Treasury grant to develop the system, based on its potential to fill the unmet medical need for an ultra-pure inhaled nitric oxide (NO) drug in this disease setting.
The Phase I SBIR grant will help establish a research partnership involving GeNO and Steward St. Elizabeth's Medical Center, Boston, MA, to study the physiological performance and biocompatibility of the GeNO liquid source (N2O4) delivery system for the delivery of inhaled NO compared with the GeNO gas cartridge system (which converts NO2) in a porcine model of acute respiratory failure.
"This grant will help GeNO add to the body of research behind our technology so that we can better understand the optimal way to deliver ultrapure nitric oxide to patients," said GeNO's Founder and President, David Fine, Ph.D. "Since the gas cartridge method of achieving NO2 to NO conversion has already been developed and is in use in clinical studies, we will focus this research on the development of the N2O4 liquid storage system into a viable NO source. The liquid source data will help inform our ambulatory system design."
GeNO's NITROSYL™ Systems aim to add a valuable option for clinicians treating a range of serious pulmonary diseases with inhaled nitric oxide. GeNO's plans for both in-hospital and ambulatory inhaled nitric oxide systems would help address the cost, complexity and lack of portability of current treatment regimens, and would potentially reach a much larger group of patients.
The product is currently in two Phase 2 trials: one, as a Pilot Study in Pulmonary Arterial Hypertension (PAH) to obtain preliminary safety and feasibility data from short term (15 minute) administration of inhaled nitric oxide, and a second 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 Identifiers NCT01092559 and 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. The company has seven US patents with numerous additional patent applications pending.
SOURCE GeNO LLC
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