Navigation Links
Ikaria(R) Receives FDA Orphan Drug Designation for Inhaled Carbon Monoxide for Delayed Graft Function in Solid Organ Transplants
Date:7/28/2008

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. Artificial Gravity receives 2008 Life Science Book Award
2. Colorado Sen. Ken Salazar receives Soil Stewardship Award
3. Childrens Memorial Hospital of Chicago receives a grant from BioMarin to support adult PKU outreach
4. Engineer receives $1.5M grant for nanoparticle cancer research
5. UC Riverside bioengineer receives high honor from chemical engineers
6. Pitt receives $2.5 million to simulate and analyze brain, immune system activity
7. NJIT biomedical engineer receives NSF Career Development Award
8. Monash researcher receives prestigious Commonwealth Health Ministers award
9. Spradling receives Gruber Foundation Genetics Prize for new genetic techniques
10. UNH receives $380,000 grant to study organic dairy as closed ecosystem
11. Ape language pioneer Savage-Rumbaugh receives honorary Ph.D. from alma mater
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/3/2017)...  Data captured by IsoCode, IsoPlexis Corporation,s ... statistically significant association between the potency of ... objective response of cancer patients post-treatment. The ... cancer patients will respond to CAR-T cell ... to improve both pre-infusion potency testing and cell ...
(Date:3/30/2017)... March 30, 2017 The research team of ... three-dimensional (3D) fingerprint identification by adopting ground breaking 3D fingerprint minutiae ... realm of speed and accuracy for use in identification, crime investigation, ... cost. ... A research ...
(Date:3/29/2017)... 2017  higi, the health IT company that operates ... America , today announced a Series B investment ... EveryMove. The new investment and acquisition accelerates higi,s strategy ... transform population health activities through the collection and workflow ... higi collects and secures data today on behalf of ...
Breaking Biology News(10 mins):
(Date:8/16/2017)... (PRWEB) , ... August 16, 2017 , ... ... changing into a different cell type. Many treatments for specific cancers, such as ... example of targeted treatment is androgen deprivation therapy for advanced prostate cancer. ...
(Date:8/16/2017)... ... August 16, 2017 , ... Today, 3Bar Biologics ... secured $2M in funding from an impressive group of investors, including Rev1 Ventures, ... Fund. With this investment, 3Bar is broadening availability of its groundbreaking offering that ...
(Date:8/16/2017)... 16, 2017  This year,s edition of the Inc. 5000 features a ... workforce solutions, has made the list for the third year in a ... fastest-growing private companies based on a set of quantitative metrics. In addition, ... fastest-growing companies in the Bay State . ... Inc. 5000 ...
(Date:8/15/2017)... , Aug. 15, 2017 After spending the past two ... with crowdsourced data collection, GeneFo now offers this platform to healthcare ... and amplifying support, adherence, and data collection vis a vis their ... mark the successful launch of this offer. ... GeneFo ...
Breaking Biology Technology: