Data Presented At 2009 Pediatric Academic Societies Meeting
WARRINGTON, Pa., May 5, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO), announced that data from a preclinical study using Surfaxin(r) (lucinactant) in a well-established preterm lamb model of Respiratory Distress Syndrome (RDS), demonstrated improved lung surfactant distribution as compared with Curosurf(r), the global market-leading animal-derived surfactant available today. The data were presented at the Pediatric Academic Societies Annual Meeting, which is internationally recognized as the largest, most relevant medical congress dedicated to pediatric research.
Data from the study "Comparison of two pulmonary surfactants administered to premature lambs with respect to cerebral blood flow, oxygenation and pulmonary distribution" were presented by Dr. Arlin Blood from Loma Linda University School of Medicine. It has been hypothesized that a larger dose volume of surfactant could potentially result in more homogeneous distribution of surfactant throughout the lungs and may ultimately result in improved pulmonary and clinical outcomes. The objective of the study was to compare Surfaxin, at a dose of 5.8 mL/kg (the dose used in the Surfaxin Phase 3 clinical trials for RDS), with Curosurf, at a dose of 2.5 mL/kg (the dose prescribed in its label), in the well-established preterm lamb model. The lungs of preterm lambs closely resemble those of human lungs in development, structure, and function and are most relevant to study the pathophysiology and treatment of RDS. The lambs were mechanically ventilated and received via endotracheal administration either Surfaxin or Curosurf.
The data showed that both surfactants significantly increased pulmonary compliance and tidal volume in this preterm lamb model of RDS without adversely affecting heart rate, blood pressure, or cerebral blood flow, irrespective of the dose volume employed. However, significantly more homogeneous lung distribution of Surfaxin (p < 0.001) was observed compared with Curosurf, as measured by pulmonary distribution of a mix of gold-labeled microspheres and surfactant.
Robert Segal, M.D., Senior Vice President and Chief Medical Officer of Discovery Labs, commented, "Surfaxin was specifically formulated to provide both a smooth onset of action and a durable effect at a dose volume that would result in better lung distribution. The data from this study supports prior observations in other preclinical models that the clinical dose volume chosen for Surfaxin is likely to result in more uniform distribution throughout the lung. Of particular importance was the observation that there were no differences between Surfaxin and Curosurf following dosing in the stability of blood pressure, heart rate and cerebral blood flow, despite significantly different dose volumes of the surfactants studied."
Preterm infants are often born with a lack of natural lung surfactant and are unable to absorb sufficient oxygen, leaving them at risk for RDS. Surfaxin is a synthetic, peptide-containing surfactant that is structurally similar to human lung surfactant, a substance produced naturally in the lung and essential for survival and normal respiratory function.
