WARRINGTON, Pa., Sept. 22, 2010 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) announces that new data from a pre-clinical study regarding Surfaxin ® (lucinactant) was recently published in Pediatric Research. The study was conducted at Loma Linda University using the preterm lamb model which is recognized by the neonatal academic community as a well-established pre-clinical model of human respiratory distress syndrome (RDS). The results of the study demonstrate that lung function following Surfaxin exposure compares favorably to Curosurf ®, an animal-derived and current market leading surfactant, when administered to surfactant-deficient preterm lambs. Additionally, pulmonary distribution of surfactant was significantly improved with Surfaxin when compared with that of Curosurf in this study. Dr. Thomas F. Miller, Chief Operating Officer of Discovery Labs, commented, "In this study, Dr. Terry and colleagues observed a significantly improved lung-distribution profile favoring Surfaxin versus Curosurf, supporting a potential advantaged dosing-volume strategy to protect the lungs of RDS infants. We are pleased with the continued interest of the academic neonatology community in our novel surfactant technology platform and we are fortunate to collaborate with such well-respected thought leaders as those at Loma Linda University." Pediatric Research is a prominent peer-reviewed journal that publishes results of significant clinical and laboratory studies intended for research-oriented pediatricians. The published manuscript is: Pulmonary Distribution of Lucinactant and Poractant Alfa and Their Peridosing Hemodynamic Effects in a Preterm Lamb Model of Respiratory Distress Syndrome ( Terry et al.) Pediatric Research 68: 193-198, 2010. The objective of the study was to compare responses to two surfactants with different dose volumes (Surfaxin 5.8 mL/kg and Curosurf 2.5 mL/kg) given to newly-delivered preterm lambs with established RDS. Both surfactants improved lung function and oxygenation, with stable blood pressure and no significant changes in cerebral blood flow. Intrapulmonary distribution of surfactant was significantly improved with Surfaxin ( p < 0.05) compared to Curosurf when assessed with an established methodology. About Surfaxin Discovery's Labs' surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant, a substance produced naturally in human lungs and essential for breathing. If approved, Surfaxin would be the first synthetic, peptide-containing surfactant available for commercial use in neonatal medicine. The safety and efficacy of Surfaxin for neonatal RDS has been previously demonstrated in a Phase 3 clinical program. Surfaxin is currently under review by the U.S. Food and Drug Administration (FDA) for potential marketing approval for the prevention of RDS in premature infants and is the subject of a Complete Response Letter. The Company believes that it remains on track to submit a complete response to the FDA in the first quarter of 2011, potentially leading to Surfaxin approval that year.
Surfaxin is an investigational drug product that has not been approved by the FDA or any other world health regulatory authority. The study results reported above include information that may be of interest to healthcare practitioners; however, the clinical relevance of these results has not been fully established and further scientific investigation may be warranted.About Pediatric Research Pediatric Research presents the work of leading authorities in pediatric pulmonology, neonatology, cardiology, hematology, neurology, developmental biology, fetal physiology, endocrinology and metabolism, gastroenterology, and nutrition. Directed to research-oriented pediatricians and faculty, the journal publishes the results of significant clinical and laboratory studies. The Journal includes original peer-reviewed articles, abstracts of society meetings, state-of-the-art reviews, as well as supplements on pediatric health issues. Pediatric Research is the official publication of the American Pediatric Society, the European Society for Paediatric Research, and the Society for Pediatric Research. About Discovery Labs Discovery Laboratories, Inc. is a biotechnology company developing KL4 surfactant therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol or lyophilized formulations. In addition, Discovery Labs' proprietary capillary aerosolization technology produces a dense aerosol, with a defined particle size that is capable of potentially delivering aerosolized KL4 surfactant to the deep lung without the complications currently associated with liquid surfactant administration. Discovery Labs believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. For more information, please visit our website at www.Discoverylabs.com. Forward Looking Statements To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties, including those related to the Company's pre-clinical and clinical research and development activities, are described in Discovery Labs' filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.
CONTACT: Linnden Communications Media relations: Michelle Linn 508-362-3087 Discovery Laboratories, Inc. Investor relations: John G. Cooper, President and Chief Financial Officer 215-488-9490