WARRINGTON, Pa., Oct. 29, 2008 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) today announced that results from pre-clinical studies regarding its novel KL-4 surfactant technology were presented at two key medical congresses in October. Pre-clinical data supporting the use of KL-4 surfactant in the treatment of Cystic Fibrosis were presented at the International Society for Aerosols in Medicine (ISAM)/University of North Carolina (UNC) Symposium on mucociliary clearance. Additionally, pre-clinical Surfaxin(r) and Aerosurf(tm) data were presented at the European Academy of Pediatrics (EAP), a prestigious pediatric congress attended by 2,500 pediatric clinicians, researchers, and nurses from over 85 countries.
Robert Segal, M.D., F.A.C.P., Senior Vice President and Chief Medical Officer of Discovery Labs, commented, "The selection of our pre-clinical studies for presentation at two key congresses underscores the medical community's continued interest in the potential application of our KL-4 surfactant to address a variety of respiratory disorders. The results of these studies demonstrate the unique properties of our KL-4 technology platform and support its potential application to address a variety of diverse pulmonary disorders, including Cystic Fibrosis and chronic obstructive pulmonary disease. We are extremely excited that the information has been made available to key medical practitioners who have a clear interest in finding new approaches to treat lung disease."
Discovery Labs' KL-4 Surfactant Replacement Therapy (SRT) technology produces a peptide-containing synthetic surfactant that is structurally similar to human pulmonary surfactant. Surfaxin, Discovery Labs' lead SRT technology platform product, is the subject of an Approvable Letter from the U.S. Food and Drug Administration (FDA) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Surfaxin is also being developed for other neonatal and pediatric indications. Aerosurf, Discovery Labs' aerosolized SRT, is being developed to potentially obviate the need for intubation and conventional mechanical ventilation and holds the promise to significantly expand the use of surfactants in respiratory medicine.
Presentations at the October medical congresses include:
Testing the Ciliostimulatory and Mucokinetic Activity of Lucinactant Using the Frog Palate Mucociliary Model: Malcolm King, et. al. Division of Pulmonary Medicine, University of Alberta; Presented at the 2008 ISAM/UNC Symposium
The effect of lucinactant (KL-4 surfactant) on mucus clearance in a well- established pre-clinical model was studied. KL-4 surfactant was shown to increase the rate of mucociliary clearance in a dose-dependent manner, supporting the potential use of KL-4 surfactant in pulmonary disorders with compromised mucus clearance, such as Cystic Fibrosis and chronic obstructive pulmonary disease (COPD).
Aerosurf(tm) Reduces Lung Inflammation, Improves Lung Mechanics and Preserves Lung Histomorphometry in Spontaneously Breathing, CPAP-Supported Preterm Lambs: Marla R. Wolfson, et. al., Temple University School of Medicine in Philadelphia; Presented at the 2008 European Academy of Pediatrics Congress
A pre-clinical study assessed the potential advantage of treatment with Aerosurf plus CPAP (continuous positive airway pressure) compared with CPAP alone in pre-term lambs. The lungs of pre-term 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 following observations were noted: * Improvements in oxygenation and lung compliance were significantly greater in animals treated with Aerosurf vs. CPAP alone (p less than 0.05). * Treatment with Aerosurf resulted in significant reductions in key markers of inflammation, including interleukin-6 and interleukin-8, compared with CPAP alone (p less than 0.05). * Treatment with Aerosurf resulted in significantly improved structural integrity of the lung demonstrated by preserving lung tissue structure to a greater degree compared with CPAP alone (p less than 0.05). * Aerosurf was well tolerated and interfaced effectively with CPAP respiratory support.
Surfaxin(r) (lucinactant) Significantly Attenuates Inflammation and Preserves Lung Structural Integrity vs. Animal-derived Surfactants in a RDS Model: Marla R. Wolfson, et al., Temple University School of Medicine in Philadelphia; Presented at the 2008 European Academy of Pediatrics Congress
In a pre-clinical study, pre-term lambs were randomized to receive, by intratracheal instillation, either Surfaxin (lucinactant), Survanta(r) (beractant), Curosurf(r) (poractant alfa), or no surfactant replacement therapy. The following observations were noted: * Lambs treated with Surfaxin had significantly improved lung function compared with lambs treated with either Survanta, Curosurf, or no surfactant replacement as demonstrated by a sustained oxygenation response and lower ventilatory pressure requirements (p less than 0.05). * Lambs treated with Surfaxin had significantly better structural integrity of lung tissue, as assessed by histologic evaluation, and lower levels of inflammatory mediators in both blood and lung tissue compared with lambs treated with Survanta or no surfactant replacement therapy (p less than 0.05).
Both Surfaxin and Aerosurf are investigational products that have not been approved by the U.S. FDA or any other world health regulatory authorities. The data listed above include information that may be of interest to healthcare practitioners; however, the clinical relevance of this information has not been fully established.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Replacement Therapies (SRT) for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' technology produces a peptide-containing synthetic surfactant that is structurally similar to pulmonary surfactant. Discovery Labs believes that, with its proprietary technology, SRT has the potential, for the first time, to address a variety of respiratory diseases affecting neonatal, pediatric and adult patients.
Surfaxin(r), the Company's lead product from its SRT pipeline, is the subject of an Approvable Letter from the FDA for the prevention of Respiratory Distress Syndrome in premature infants. Surfaxin is also being developed for other neonatal and pediatric indications. Aerosurf(tm), Discovery Labs' aerosolized SRT, is being developed to potentially obviate the need for intubation and conventional mechanical ventilation and holds the promise to significantly expand the use of surfactants in respiratory medicine. For more information, please visit our website at www.Discoverylabs.com.
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, including, without limitation, the risks that: Discovery Labs response to the recent Approvable Letter for Surfaxin may not satisfy the FDA; the FDA or other regulatory authorities may not accept, or may withhold or delay consideration of, any applications that Discovery Labs may file for its products, or may not approve any such applications or may limit marketing of such products to particular indications or impose unanticipated label limitations; changes in the national or international political and regulatory environment may make it more difficult for Discovery Labs to gain FDA or other regulatory approval of its products; Discovery Labs may be unable to raise additional capital or enter into additional collaboration agreements (including strategic alliances for development or commercialization of SRT); Discovery Labs' lengthy and costly research and development programs, including pre-clinical studies, clinical trials and other efforts to gain regulatory approval for any of its products, including Surfaxin, may not progress or may be subject to potentially significant delays or regulatory holds, or fail; Discovery Labs or its contract manufacturers or materials suppliers may be unable to successfully manufacture adequate supplies of its drug product or drug substances when needed or in amounts sufficient to meet demand; Discovery Labs may be unable to develop, manufacture and successfully commercialize products that combine Discovery Labs' drug products with innovative aerosolization technologies; Discovery Labs may be unable to profitably develop and market its products; Discovery Labs may be unable to maintain and protect the patents and licenses related to its SRT technology; other companies may develop competing therapies and/or technologies or health care reform may adversely affect Discovery Labs; and Discovery Labs may become involved in securities, product liability and other litigation. The foregoing risks and others are further 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.