Navigation Links
Ikaria® Completes Patient Enrollment in Pivotal Phase III Trial for Bronchopulmonary Dysplasia
Date:2/27/2012

HAMPTON, N.J., Feb. 27, 2012 /PRNewswire/ -- Ikaria, Inc., a critical care company focused on developing and commercializing innovative therapies for critically ill patients, today announced that it has enrolled the last patient into its Pivotal Phase III trial investigating the use of inhaled nitric oxide (iNO) in premature infants with bronchopulmonary dysplasia (BPD).  The trial, which commenced in December 2009, enrolled its last patient six weeks ahead of schedule. The trial design includes a one-year follow-up assessment, as discussed with the U.S. Food and Drug Administration (FDA).

Bronchopulmonary dysplasia is a cause of chronic lung disease that develops most commonly in pre-term infants (less than 30 weeks of gestational age) with birth weights less than 1,250 grams who are treated with oxygen and positive-pressure ventilation. Bronchopulmonary dysplasia is even more pronounced in very pre-term infants (less than 26 weeks of gestational age) with birth weights less than 1,000 grams and who have been treated for respiratory distress syndrome.

This multi-center, double blind, placebo-controlled, randomized clinical trial, entitled, Inhaled Nitric Oxide for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants, or the "NewNO Trial," aims to determine whether preterm infants who require mechanical ventilation or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO. In eligible subjects, iNO was administered continuously at a starting dose of 20ppm for a duration of 24 days.

"The treatment of BPD is an area of great interest and much debate within the neonatology community given the challenges in treating this condition," stated Daniel Tasse, Chairman and CEO of Ikaria.  "We are hopeful that the data from this trial will provide the definitive answers the medical community has been seeking, particularly in light of the recommendations generated by the 2010 NIH Consensus Conference on BPD."

"Enthusiastic enrollment, which allowed us to beat the original enrollment timeline, speaks both to the unmet medical need and the profound interest by the medical community to address BPD," added Douglas A. Greene, M.D., Executive Vice President of Research & Development at Ikaria.

Inhaled nitric oxide selectively relaxes the cells of the pulmonary vasculature, resulting in increased blood flow through the lungs and delivery of more oxygenated blood to the body. Inhaled nitric oxide may also have beneficial effects on the development of pulmonary blood vessels and airspaces.  

Inhaled nitric oxide is available as INOMAX® (nitric oxide) for inhalation, a vasodilator, which, in conjunction with ventilation and other appropriate agents, treats term and near-term newborns (>34 weeks gestation) with hypoxic respiratory failure associated with evidence of pulmonary hypertension.  INOMAX is not approved for use in BPD.

About INOMAX®
INOMAX® is a vasodilator, which, in conjunction with ventilator support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.

INOMAX should not be used in the treatment of neonates known to be dependent on right-to-left shunting of blood. Abrupt discontinuation of INOMAX may lead to a worsening condition. Methemoglobinemia is a dose-dependent side effect of inhaled nitric oxide therapy.  Nitrogen dioxide (NO2) forms rapidly in gas mixtures containing nitric oxide and oxygen, and therefore may cause airway inflammation and damage. Methemoglobin, NO2, and FiO2 should be monitored during nitric oxide administration. 

Please see attached prescribing information.  For additional information about INOMAX, please visit www.inomax.com

About Ikaria, Inc.
Ikaria, Inc. is a critical care company focused on developing and commercializing innovative therapies designed to address the significant needs of critically ill patients. The company's lead product is INOMAX® (nitric oxide) for inhalation, the only FDA-approved drug for the treatment of hypoxic respiratory failure associated with pulmonary hypertension in term and near-term infants. It is offered through the INOMAX therapy package, an all-inclusive offering of drug product, drug-delivery system, on-site training and 24/7/365 technical assistance and support. The INOMAX therapy package also is marketed in Puerto Rico, Canada, Australia, Mexico and Japan. The company is investigating additional indications for INOMAX in bronchopulmonary dysplasia, and for inhaled nitric oxide with the INOpulse® DS drug-delivery system as a drug-device combination product in pulmonary arterial hypertension (PAH) and chronic obstructive pulmonary disease (COPD). Ikaria's late-stage pipeline is also comprised of LUCASSIN® (terlipressin), a potential treatment for Hepatorenal Syndrome Type 1; as well as Bioabsorbable Cardiac Matrix (BCM), a potential treatment for preventing cardiac remodeling and subsequent congestive heart failure following acute myocardial infarction. Ikaria is headquartered in Hampton, NJ, with a research facility in Madison, WI, and manufacturing facilities in Port Allen, LA and Madison, WI.  Please visit www.ikaria.com.Company Contact:Media Contact:Samina Bari

Claire SojdaIkaria, Inc.

Tiberend Strategic Advisors, Inc.(908) 238-6372  

(212) 827-0020samina.bari@ikaria.com

csojda@tiberend.com 

  

 


'/>"/>
SOURCE Ikaria, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Ikaria® to Present at 14th Annual BIO CEO & Investor Conference
2. Ikaria® to Present at 2011 BIO Investor Forum
3. Ikaria® To Present at 2011 BIO Business Forum and International Convention
4. GeneLink Biosciences Completes Sale of GeneWize Life Sciences
5. CitiusTech Completes Another Milestone Year: Revenues Grow by 59% in 2011
6. Auxogyn Completes $20 Million In Series A Funding
7. goBalto Completes a Successful FDA 21 CFR Part 11 Compliance Audit
8. MiMedx Group Completes $5,000,000 Private Placement
9. PDL BioPharma Completes Regular Quarterly Dividend Payment
10. CeNeRx BioPharma Completes $4.85 Million Financing
11. Aratana Therapeutics Completes $15 Million Series B Financing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... ... May 03, 2016 , ... Leading CEOs from biotech, ... 31st and June 1st at The Four Seasons Hotel Boston. , The Boston ... sciences, offering exclusive access to key decision makers who influence deal making and ...
(Date:5/3/2016)... THE WOODLANDS, Texas , May 3, 2016 /PRNewswire/ ... board certified plastic surgeon in The Woodlands, ... technology that destroys 24 percent of treated fat cells ... men and woman. Close to 90 percent of Americans ... effective treatment options. Nonsurgical fat reduction procedures are a ...
(Date:5/2/2016)... ... ... StarNet Communications Corp, ( http://www.starnet.com/ ) a leading publisher of remote Linux ... to its flagship X-Win32 PC X server. The new modules enable X-Win32 to ... over encrypted SSH. , Traditionally, users of PC X servers deploy the XDMCP protocol ...
(Date:4/29/2016)... April 29, 2016 According ... Market Research "Separation Systems for Commercial Biotechnology Market ... and Forecast 2015 - 2023", the separation systems ... 10,665.5 Mn in 2014 and is projected to ... to 2023 to reach US$ 19,227.8 Mn in ...
Breaking Biology Technology:
(Date:3/14/2016)... , March 14, 2016 NXTD ) ... mobile commerce market, announces the airing of a new series ... the week of March 21 st .  The commercials will ... its popular Squawk on the Street show. --> ... the growing mobile commerce market, announces the airing of a ...
(Date:3/10/2016)... Pa. , March 10, 2016   Unisys Corporation ... Customs and Border Protection (CBP) is testing its biometric ... San Diego to help identify certain non-U.S. ... . The test, designed to help determine the efficiency ... environment, began in February and will run until May 2016. ...
(Date:3/3/2016)... -- FlexTech, a SEMI Strategic Association Partner, awarded five FLEXI ... Leadership in Education, and, in a category new this ... year of the FLEXI Awards and the winners join ... past years . Judging was done on a set ... by a panel of non-affiliated, independent, industry experts. ...
Breaking Biology News(10 mins):