Navigation Links
FDA Clears GeNO LLC's Investigational New Drug Application for Clinical Trials With Its NITROSYL™ Inhaled Nitric Oxide System
Date:12/2/2010

COCOA, Fla., Dec. 2, 2010 /PRNewswire/ -- GeNO LLC (www.genollc.com), a privately held, advanced development-stage technology company, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a clinical trial with the GeNO NITROSYL™ (Inhaled Nitric Oxide) System for treatment of pulmonary hypertension in patients with Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis, (PH-IPF WHO Group 3) and Pulmonary Arterial Hypertension, (PAH, WHO Group 1).

This FDA clearance enables GeNO to begin a US, multicenter, Phase 2 dose escalation study in which both patient populations will receive up to a maximum of 80 parts per million (ppm) of Nitric oxide (NO) delivered for up to 150 minutes with GeNO's stand-alone NITROSYL™ platform. The study is subject to Institutional Review Board (IRB) approval.

"The clearance of this IND is a major milestone for the company as we are committed to developing treatment for these grave chronic conditions," commented GeNO LLC Founder and President David Fine, Ph.D.  "Today's development also lays the groundwork for our patented ambulatory platform, which has the potential to greatly expand the use of inhaled nitric oxide to many new chronic indications due to its simplicity and ease-of-use."

GeNO's stand-alone gas cylinder stores premixed nitric oxide as nitrogen dioxide in either air or oxygen.  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.  The company has also developed 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 attached to a hip or arm holster and provides up to a four-day continuous supply of inhaled nitric oxide for chronic use.  

"This IND moves GeNO's product from a diagnostic to a treatment setting, and the planned dose-escalation study with the gas cylinder will inform the final design of GeNO's NITROSYL™ ambulatory platform," said GeNO Vice President Robert F. Roscigno, Ph.D.  "This regulatory clearance by the FDA is an important step in our efforts to develop the NITROSYL™ platform and expand our focus on developing and commercializing novel therapeutics for chronic, life-threatening diseases."

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.  

In March 2010, the FDA approved the company's IND to test the NITROSYL™ stand-alone gas cylinder as a diagnostic agent in PAH. The resulting Phase 2 trial is ongoing for the diagnostic indication.  

ABOUT GENO LLCGeNO 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 acute in-hospital care, ambulatory and in-home use for potential chronic treatment.  GeNO's platforms 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 PAH.  The company has five issued US patents with additional patent applications pending. Media Contacts: Carla Burigatto, 610-457-2178

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

bheffron@ctpboston.com
'/>"/>

SOURCE GeNO LLC
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Clears Volpara™ Breast Imaging Software for Automatic Calculation of Volumetric Breast Density
2. FDA Clears Cymbalta to Treat Chronic Musculoskeletal Pain
3. FDA Clears Software Upgrade for Fenwal Plasma-Collection System
4. FDA Clears AirStrip RPM for CRITICAL CARE & CARDIOLOGY Remote Patient Monitoring Solutions
5. FDA Clears Xlumenas NAVIX(TM) Access Device
6. FDA Clears Three Additional Antimicrobials for Use on TREK Sensititre(R) In Vitro Diagnostic (IVD) MIC Susceptibility Plates: Minocycline and Telavancin Used to Treat MRSA and Other Infections; and Tigecycline, Now Cleared for Streptococcus Pneumoni
7. FDA Clears the Fenwal Amicus(R) Separator System for Collecting Platelets in New Additive Solution
8. FDA Grants Cequent IND - Clears Way for First-Ever Clinical Trial of Orally Delivered RNAi Therapeutic: CEQ508, a tkRNAi Drug Candidate in Oncology
9. FDA Clears the First Rapid Test to Detect Bacteria in Pooled Platelets
10. U.S. Food and Drug Administration Clears Alcatel-Lucent Remote Patient Monitoring Solution for Sale in the United States
11. Private Investment Firm Czura Thornton Today Introduces Clearstone Central Laboratories as the Newest Member of the Czura Thornton Life Science Group
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/30/2021)... ... March 29, 2021 , ... The University of Texas Health Science Center ... San Antonio Multispecialty and Research Hospital, a destination center for research and treatment of ... In a nod to the COVID-19 pandemic, the ceremony was held virtually. , William ...
(Date:3/30/2021)... ... March 29, 2021 , ... Iora Health ... primary care, has partnered with Devoted Health , one of the fastest-growing ... across Maricopa County and provides seniors with the highest-quality care and experience possible, ...
(Date:3/30/2021)... CITY (PRWEB) , ... March 29, 2021 , ... ... has joined the Vaccine Credential Initiative (VCI), a group bringing together leading health ... record of vaccination status, based on open, interoperable standards. By joining the VCI ...
Breaking Medicine Technology:
(Date:3/30/2021)... , ... March 29, 2021 , ... ... the 21st Century , A Virtual Workshop Presented by WCG FDAnews and Cerulean ... 4:30 pm EDT, https://wcg.swoogo.com/modern-sop-and-quality-systems , Are one’s SOPs written for the ...
(Date:3/30/2021)... ... March 29, 2021 , ... According to data released ... reproductive age (13-44) in need of publicly funded contraception live in counties impacted by ... Colorado’s 64 counties have lost some of their Title X resources. , The ...
(Date:3/30/2021)... ... March 29, 2021 , ... Health Literacy Innovations (HLI), a ... confusion due to low health literacy today announces a new partnership with the ... work with ACAP’s member Safety Net Health Plans, those that provide comprehensive health ...
(Date:3/30/2021)... ... ... Dr. Colin Campbell is proud to announce the 1 year anniversary in their new state ... internal medicine and is a primary care specialist who has been practicing for 23 years. ... keep South Jersey healthy one patient at a time. , “Over the past year, Dr. ...
(Date:3/30/2021)... ... March 30, 2021 , ... The COVID-19 ... and survivors; their families; and their caregivers. Crossroads4Hope is addressing the needs of ... emotional support system, MyGo2Support, which meets needs of people impacted by cancer, no ...
Breaking Medicine News(10 mins):