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.
SOURCE Ikaria, Inc.