WARRINGTON, Pa. Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced the publication of SURFAXIN (lucinactant) preclinical data in Pediatric Research. Using a well-established preterm lamb model of respiratory distress syndrome (RDS), study investigators concluded that early intervention with SURFAXIN may mitigate progression of pulmonary pathophysiological consequences of RDS when compared with the animal-derived surfactants Curosurf and Survanta.
The newly-published data can be found in the September 2012 issue of Pediatric Research, a peer-reviewed medical journal widely read by academic neonatologists and other neonatal health care professionals.
According to study findings, subjects receiving surfactant replacement therapy (SRT) using SURFAXIN had improved sustained oxygenation and lower ventilatory pressure requirements (p < 0.05) compared with no SRT or SRT using Curosurf or Survanta. In addition, SURFAXIN treatment resulted in an attenuated lung and systemic inflammatory response as well as a more uniform and robust preservation of lung structural integrity.
"Findings such as these improve our understanding of the role of SURFAXIN in modulating lung inflammation and preserving lung structure, and suggest that SURFAXIN may provide protection to the lung on both a mechanical and cellular level for potentially improved clinical outcomes," said Dr. Marla R. Wolfson, lead investigator and Professor of Physiology, Pediatrics, and Medicine at the Temple University School of Medicine. "The use of this RDS model allows us to further our understanding of potential mechanistic differences between surfactants in a way that may explain observations from clinical trials."
Investigators found that the lungs of preterm lambs that were treated with SURFAXIN were more homogenously expanded both within and between lung regions, a finding that is suggestive of more uniform distribution of surfactant throughout the lung. Investigators also found that the lungs of SURFAXIN treated lambs had less cellular debris and fewer inflammatory cells when compared with the lungs of non-treated lambs and the lambs treated with Curosurf and Survanta. The investigators also noted lower levels of inflammatory mediators following treatment with SURFAXIN compared with negative controls as well as both animal-derived surfactants.
RDS is a condition in which premature infants are born with an insufficient amount of pulmonary surfactant, a substance produced naturally in the lungs and essential for breathing. Today, infants with RDS often require surfactant replacement therapy along with mechanical ventilation to survive. Approximately 90,000 premature infants in the United States are treated annually with currently available animal-derived surfactants made from cow or pig lung extract.
This is the first publication of these data, which have been presented previously in part at medical conferences. The study was funded in part by a grant from Discovery Laboratories, Inc. Dr. Marla Wolfson does not have a financial interest in Discovery Laboratories, Inc.
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