Navigation Links
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
Date:1/29/2013

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's nitric 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
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Significant Pre-Clinical Data in Acute Lung Injury
2. Charleston Laboratories, Inc. Begins Enrollment for CL-108 Phase 3 Clinical Trial
3. MicroConstants China Signs Site Management Organization Agreement with the Clinical Research Center of No. 307 Hospital
4. GLP Preclinical Studies Demonstrate nContact Ablation Lesions Are Complete and Transmural
5. Metabolic Solutions Development Company announces publication of Phase 2b data in Clinical Pharmacology & Therapeutics
6. Projecis Demonstrates Flagship Project Management Software at Outsourcing Clinical Trials-West in San Francisco
7. Topokine Therapeutics Secures Financing from Schooner Capital to Advance Clinical Development of XAF5 Gel
8. Hadasit Bio-Holdings Portfolio Companies Receive Funding to Support Clinical Trial Preparations and Obtain Regulatory Approvals in U.S. and Europe
9. Omeros Announces Positive OMS302 Safety Data in Phase 3 Clinical Trial
10. Diet Doc Weight Loss Diets and Fast Weight Loss Plans To Seek Patent Protection for the Most Clinically Advanced Diet Offered in the United States.
11. Clinical Data from NewLink Genetics HyperAcute Prostate Cancer Immunotherapy Published in Journal of Immunotherapy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... 8, 2016 According to ... by Product (Actual Sugars, Sugar Alcohols, Artificial Sweeteners), ... Tonicity Agents), Formulation (Oral, Topical, Parenteral) - Global ... has witnessed healthy growth during the last decade, ... of 4.3% between 2016 and 2021 to reach ...
(Date:12/8/2016)... December 8, 2016 According to a new market ... Sleep, Fetal), Therapeutic (Pain, Insulin)), End Use (Sports, Fitness, RPM), Type (Smart ... MarketsandMarkets, the global market, in terms of value, is projected to reach ... CAGR of 18.0% during the forecast period. ... ...
(Date:12/8/2016)... , Dec. 8, 2016  Hanson Research, ... of dissolution testing and diffusion testing instruments for ... acquired by Teledyne Instruments, Inc. ("Teledyne"). The move ... line of precision testing instruments, as well as ... development of new products and services. ...
Breaking Medicine Technology:
(Date:12/7/2016)... ... 07, 2016 , ... "Today, MHA and mental health advocates ... systems reform legislation in more than fifty years. We applaud the bipartisan action ... elected officials to improving mental health services and supports in our nation. , ...
(Date:12/7/2016)... ... December 07, 2016 , ... Children ... bodies, a researcher at the Icahn School of Medicine at Mount Sinai has ... found that when young children are exposed to secondhand marijuana smoke, measurable amounts ...
(Date:12/7/2016)... (PRWEB) , ... December 07, 2016 , ... ... the release of Smart Device Remote Control through a new partnership with Splashtop ... platforms and strengthens its mobile solutions to help businesses maximize their uptime and ...
(Date:12/7/2016)... ... December 07, 2016 , ... ... Presence Technology, S.L. (“Presence”) for a purchase price of approximately $17.4 million ... considerations. Presence’s annual revenue is approximately $13.2 million. Headquartered in Barcelona, Spain, ...
(Date:12/7/2016)... ... 07, 2016 , ... It is vital for any lab to secure funding, ... The team at Beckman Coulter has designed Kaluza, templates with advanced analytical tools to ... to operate in a GLP (Good Laboratory Practice) fashion. , With features designed to ...
Breaking Medicine News(10 mins):