Ikaria® Completes Patient Enrollment in Pivotal Phase III Trial for Bronchopulmonary Dysplasia
-- Enrollment Concludes Ahead of Schedule --
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.
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.