Navigation Links
Ikaria(R) Receives FDA Orphan Drug Designation for Inhaled Carbon Monoxide for Delayed Graft Function in Solid Organ Transplants
Date:8/10/2008

CLINTON, N.J., July 28 /PRNewswire/ -- Ikaria Holdings, Inc., a fully integrated critical care biotherapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for inhaled carbon monoxide for use in the reduction of the incidence and severity of delayed graft function (DGF) in patients undergoing solid organ transplantation.

Ralf Rosskamp, M.D., Executive Vice President of Research and Development for Ikaria, commented, "The designation of orphan drug status is a significant step that will greatly facilitate the development of inhaled carbon monoxide as a potential treatment for DGF in solid organ transplants. Pre-clinical data has demonstrated that the compound may possess anti-inflammatory, cytoprotective and anti-apoptotic properties that could potentially improve ischemic-reperfusion mediated malfunction in transplanted organs and allow for an important advance in solid organ transplantation. We look forward to advancing our research of inhaled carbon monoxide as part of our overall goal of delivering new therapies for the underserved critical care market."

Ikaria is currently conducting a single-blind, placebo controlled, dose-escalating Phase 2 study of inhaled carbon monoxide in patients receiving renal transplants. The primary endpoint of the study is to evaluate the safety and tolerability of increasing carbon monoxide dose levels when administered as an inhaled gas to kidney transplant patients over the course of one hour in an acute hospital setting. The study was initiated in August 2007 and is currently enrolling patients.

Delayed graft function following kidney transplantation represents an unmet medical need with considerable health burdens. DGF occurs when the kidney does not function sufficiently after transplantation, often requiring dialysis to support the patient. The underlying cause of DGF is ischemia-reperfusion injury, which occurs when blood flow is returned to damaged tissue, leading to an inflammatory response that could result in poor organ function. In the United States, approximately 28,000 patients received a solid organ transplant in 2007.

Orphan drug designation provides an accelerated FDA review process, tax advantages and a seven-year period of market exclusivity in the US upon product approval.

About Ikaria Holdings, Inc.

Ikaria Holdings, Inc. is a fully integrated biotherapeutics company focused on the development and commercialization of innovative pharmaceutical and biological products and drug/device combinations for the critically ill in the hospital and ICU setting. The company's product, INOmax(R) (nitric oxide) for inhalation, is an FDA-approved drug for the treatment of hypoxic respiratory failure in term and near-term newborns. The drug also is approved by regulatory authorities and used in Canada, Europe, Australia and Latin America. In addition to the ongoing clinical development as well as the marketing and selling of its INOmax product, Ikaria is engaged in a number of Phase 2 trials with Covox(R) (carbon monoxide) for inhalation and Phase 1 trials with hydrogen sulfide (H2S) for various critical care indications. Ikaria has a staff of approximately 400 people and is headquartered in Clinton, NJ, with research facilities in Seattle, WA and Madison, WI and manufacturing in Port Allen, LA. For more information on Ikaria, please visit http://www.ikaria.com.

CONTACTS: Matthew Bennett, Ikaria, (908) 238-6673, matthew.bennett@ikaria.com; or Jason Rando, The Ruth Group, 646-536-7025, jrando@theruthgroup.com


'/>"/>
SOURCE Ikaria Holdings, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology news :

1. Ikaria(R) Receives FDA Orphan Drug Designation for Inhaled Carbon Monoxide for Delayed Graft Function in Solid Organ Transplants
2. Artificial Gravity receives 2008 Life Science Book Award
3. Colorado Sen. Ken Salazar receives Soil Stewardship Award
4. Childrens Memorial Hospital of Chicago receives a grant from BioMarin to support adult PKU outreach
5. Engineer receives $1.5M grant for nanoparticle cancer research
6. UC Riverside bioengineer receives high honor from chemical engineers
7. Pitt receives $2.5 million to simulate and analyze brain, immune system activity
8. NJIT biomedical engineer receives NSF Career Development Award
9. Monash researcher receives prestigious Commonwealth Health Ministers award
10. Spradling receives Gruber Foundation Genetics Prize for new genetic techniques
11. UNH receives $380,000 grant to study organic dairy as closed ecosystem
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/2/2016)... 2, 2016 Perimeter Surveillance & ... Systems, Physical Infrastructure, Support & Other Service  ... offers comprehensive analysis of the global Border ... generate revenues of $17.98 billion in 2016. ... a leader in software and hardware technologies for advanced ...
(Date:5/24/2016)... 24, 2016 Ampronix facilitates superior patient care by providing unparalleled technology to ... display is the latest premium product recently added to the range of products distributed ... ... ... Imaging- LCD Medical Display- Ampronix News ...
(Date:5/16/2016)... NEW YORK , May 16, 2016   ... authentication solutions, today announced the opening of an IoT ... to strengthen and expand the development of embedded ... provides an unprecedented level of convenience and security with ... to authenticate one,s identity aside from DNA. EyeLock,s platform ...
Breaking Biology News(10 mins):
(Date:6/24/2016)... 24, 2016  Regular discussions on a range of subjects ... the two entities said Poloz. Speaking at a ... , he pointed to the country,s inflation target, which ... "In certain areas ... have common economic goals, why not sit down and address ...
(Date:6/24/2016)... ... ... Researchers at the Universita Politecnica delle Marche in Ancona combed medical journal ... Their findings are the subject of a new article on the Surviving Mesothelioma website. ... the blood, lung fluid or tissue of mesothelioma patients that can help point doctors ...
(Date:6/23/2016)... June 23, 2016   Boston Biomedical , ... compounds designed to target cancer stemness pathways, announced ... granted Orphan Drug Designation from the U.S. Food ... gastric cancer, including gastroesophageal junction (GEJ) cancer. Napabucasin ... to inhibit cancer stemness pathways by targeting STAT3, ...
(Date:6/23/2016)... 2016 Houston Methodist Willowbrook Hospital has ... Association to serve as their official health care ... Willowbrook will provide sponsorship support, athletic training services, ... coaches, volunteers, athletes and families. "We ... Association and to bring Houston Methodist quality services ...
Breaking Biology Technology: