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Ikaria Completes Dosing of Phase 1a Clinical Study for IK-1001 (Sodium Sulfide) for Injection
Date:5/19/2008

CLINTON, N.J., May 19 /PRNewswire/ -- Ikaria Holdings, Inc., a fully integrated critical care biotherapeutics company, announced today that it has completed dosing of its Phase 1a trial for its drug candidate, IK-1001 (sodium sulfide) for injection.

The study was a Phase 1, randomized, single blind, placebo-controlled, single center dose escalation study of a single bolus injection of IK-1001 in healthy volunteers to assess safety, tolerability and pharmacokinetics. The study comprised five dosing cohorts of 0.005 mg/kg, 0.01 mg/kg, 0.03 mg/kg, 0.06 mg/kg and 0.1 mg/kg with four subjects in the first cohort and eight subjects in the remaining cohorts. Subjects were monitored for adverse events. Blood and urine were sampled to determine pharmacokinetic profiles. Doses evaluated were expected to be within the therapeutic window based on preclinical animal models. At the doses tested, no adverse reactions were observed that were of clinical significance, and no clinical laboratory abnormalities were detected. The trial was conducted in Melbourne, Australia and involved a total of 36 healthy volunteers.

Ralf Rosskamp, M.D., Executive Vice President for Research and Development of Ikaria, commented, "We are very pleased with these preliminary results, which suggest that IK-1001 is a well tolerated drug at the doses tested in healthy volunteers. Pre-clinical data have demonstrated the therapeutic potential of sodium sulfide for injection as a treatment for multiple hypoxic/ischemic conditions, including myocardial infarction, cardiopulmonary bypass surgery, and acute lung injury. In conjunction with this Phase 1a trial utilizing a single bolus injection, and an ongoing second, parallel Phase 1 study utilizing a single infusion regimen to be completed in July 2008, a dose regimen can be selected for Phase 2a. With the results of both studies in hand, we will begin planning for Phase 2a trials, which, pending discussions and approval from the appropriat
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