ARF trial missed endpoint today.
>>WARRINGTON, Pa., June 9, 2010 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO - News), reports preliminary results from its Phase 2 clinical trial of Surfaxin(R) in children with Acute Respiratory Failure (ARF), a critical condition often caused in children by severe respiratory infections. The objective of the study was to evaluate the safety and tolerability of intratracheal administration of Surfaxin and to assess whether Surfaxin treatment could decrease the duration of mechanical ventilation in children with ARF.
The Phase 2 trial was a multicenter, randomized, masked, placebo-controlled estimation trial that enrolled 165 children under the age of two with ARF and compared Surfaxin treatment to standard of care alone, masked with sham air control. All children enrolled received standard of care and were randomized to receive either Surfaxin at 5.8 mL/kg of body weight or sham air. The trial enrolled patients at 24 sites located in the northern and southern hemispheres.
Key preliminary observations in this Phase 2 trial are:
Relative to the control treatment group, Surfaxin treatment reduced time on mechanical ventilation by approximately 10%, although this observation was not statistically significantly different. Duration on mechanical ventilation was 3.8 days for the Surfaxin treatment group versus 4.1 days for the control treatment group, expressed as the geometric mean (primary analysis per protocol).
Surfaxin treatment appeared generally safe and well tolerated in this trial. Statistically significant differences in the incidence of bradycardia and desaturation were observed in the Surfaxin treatment group during the dosing period versus the control treatment group. Generally, such peri-dosing events are transient and expected with intratracheal surfactant administration.
Comprehensive analysis of the data from this trial is ongoing. Further assessment of safety and tolerability, as well as in-depth analysis of additional efficacy endpoints and patient sub-populations, is expected to be completed in the third quarter of 2010. Following this analysis, Discovery Labs in collaboration with the ARF Steering Committee plans to present the comprehensive results at relevant medical congresses and submit these data for publication in a peer review journal.
Robert Segal, MD, Chief Medical Officer and Senior Vice President of Discovery Labs, commented, "Pediatric Acute Respiratory Failure represents a significant medical challenge and, unfortunately, there are no approved medical therapies that effectively treat this disorder today. Pulmonary surfactant is critical for normal respiration and may become impaired following patient exposure to a pathogen such as influenza or respiratory syncytial virus. The comprehensive data set from this Phase 2 trial is being further analyzed with the study Steering Committee as we evaluate next steps. These data are important as we are assessing, for the first time, the safety, tolerability and efficacy of intratracheally administered Surfaxin in the ARF patient population."<<
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Cheers, Tuck |
