Inhaled Nitric Oxide Data Presented at European Academy of Pediatri... ( CLINTON N.J. Oct. 25 /- Ikaria Ho...)

Inhaled Nitric Oxide Data Presented at European Academy of Pediatrics Meeting

Date:10/25/2008

CLINTON, N.J., Oct. 25 /PRNewswire/ -- Ikaria Holdings, Inc. today announced that results from its Phase III clinical trial -- INOT27, nitric oxide for inhalation for the treatment of bronchopulmonary disease (BPD) in premature babies -- were presented at the European Academy of Pediatrics in Nice, France. The pre-specified primary endpoint, survival without BPD, did not meet statistical significance, with the INOT27 treatment group achieving a 65.3% success rate compared to a 65.5% success rate for the control group (p=0.73).

BPD most commonly occurs in pre-term (less than 30 weeks of gestational age) infants with birth weights less than 1,500 g. BPD is even more pronounced in very pre-term infants (less than 26 weeks of gestational age) with birth weights less than 1,000 g. and who have been treated for respiratory distress syndrome.

"These results were quite unexpected based on prior evidence indicating the efficacy of inhaled nitric oxide in the prevention of BPD in pre-term infants," stated lead researcher Jean-Christophe Mercier, MD, MSci, Professor of Pediatrics, University of Paris -- Denis Diderot Medical School and Associate Professor, Division of Pediatric and Neonatal Intensive Care, Hopital Robert Debre, Paris. "Although the study was well designed, a lower dose was administered to higher birth weight infants than in previous studies which -- combined with certain risk-factors of the patient population -- may have contributed to these results. We hope that further research will demonstrate the potential of nitric oxide to improve outcomes for pre-term infants."

The multi-center, double-blind, controlled Phase III clinical trial, examined 800, pre-term infants ranging in gestational age from 24 weeks to 28 weeks, 6 days. All patients required the use of surfactant within 24 hours of birth or the use of CPAP, or continuous positive airway pressure, to maintain an oxygen saturation value of greater than or equal to 85 percent. U
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Inhaled Nitric Oxide Data Presented at European Academy of Pediatri...( CLINTON N.J. Oct. 25 /- Ikaria Ho...),Health