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AOP Orphan Pharmaceuticals and Lantibio Announce Positive Phase II,Study with Novel Cystic Fibrosis Therapy

VIENNA, Austria and CHAPEL HILL, N.C., US, March 06, 2007 /PRNewswire/ -- AOP Orphan Pharmaceuticals AG ("AOP Orphan") and Lantibio, Inc. ("Lantibio") today announced positive final results from their placebo controlled, double-blinded Phase II clinical study of Moli1901, an experimental compound to treat cystic fibrosis ("CF"). Moli1901 is being developed by AOP Orphan in Europe under a licensing and commercialization agreement with Lantibio. The study, performed at multiple centers in Europe, was designed to investigate safety and tolerability of aerosolized Moli1901 in adolescents (12 years of age or older) and adults with CF.

The study was first populated with 9 subjects aged 16 years and older (Phase I), followed with 9 subjects aged 12-16 years (Phase II). Safety and tolerability were assessed by spirometric evaluation of pulmonary function, vital signs, pulse oximetry, physical examinations, clinical laboratory tests, electrocardiogram (ECG), and by monitoring adverse events. Efficacy was assessed by pre-treatment and post-treatment pulmonary function evaluation measuring forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and forced expiratory flow 25-75% of FVC. Exercise tolerance and quality of life were also assessed.

Results of the study demonstrated that subjects ages 12 and older tolerated daily administration of Moli1901 over 28 days of daily dosing by the inhalation route and analysis of the data did not reveal unexpected safety concerns. Furthermore, no traces of Moli1901 were detected in the plasma of subjects indicating that the drug has limited or no systemic absorption. Notably, although the study was not powered to demonstrate efficacy, patients who received 2.5 mg Moli1901 per day demonstrated a statistically significant improvement of lung function as demonstrated by FEV1, a standard measure of lung capacity in CF patients. The median FEV1 change fro
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