WARRINGTON, Pa., Oct. 19, 2011 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO), announced that data from two scientific studies regarding the Company's aerosolized KL4 surfactant program were presented at the 2011 European Society for Paediatric Research (ESPR) Annual Meeting, internationally recognized as the largest and most relevant European medical meeting dedicated to new advancements in pediatric research. These data were initially presented at the 2011 Pediatric Academic Societies Annual Congress in May, 2011. The presented studies were as follows:
Aerosolized KL4 Surfactant Dose-Response in the Spontaneously Breathing CPAP-Supported Preterm Lamb; Dr. Wolfson, et al.
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This study was conducted to determine which dose of aerosolized KL4 surfactant would produce the optimal physiologic response in a preterm lamb model of respiratory distress syndrome (RDS) in which spontaneously breathing preterm lambs were supported by continuous positive airway pressure (CPAP). This model is widely recognized by the scientific community as a well-established pre-clinical model of RDS.
- Relative to treatment with CPAP alone, treatment with aerosolized KL4 surfactant, delivered via Discovery Labs' proprietary capillary aerosol generator (CAG) and AFECTAIRTM technologies, improved gas exchange (p < 0.05), pulmonary mechanics (p < 0.05), lung structure integrity (p < 0.05), and reduced levels of inflammatory mediators in the lung (p < 0.05) in a dose-dependent manner in the preterm lamb RDS model. Additionally, aerosolized KL4 surfactant was well tolerated and interfaced effectively with CPAP respiratory support.
Aerosolized KL4 Surfactant Improves Gas Exchange and Survival in Spontaneously Breathing Piglets With HCl Induced Acute Lung Injury; Dr. Lampland, et al.
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The objective of this study was to evaluate the effect of aerosolized KL4 surfactant in a piglet model of acute lung injury (ALI). Piglets were randomized to receive one of endotracheal bolus KL4 surfactant with extubation to continuous positive airway pressure (CPAP), aerosolized KL4 surfactant, delivered via Discovery Labs' proprietary capillary aerosol generator (CAG) and AFECTAIR technologies, while on CPAP, or CPAP alone as a control.
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Relative to control piglets on CPAP alone, treatment with either bolus or aerosolized KL4 surfactant resulted in a significant improvement in both oxygenation response (p < 0.001) and overall survival (p < 0.05) throughout the evaluation period, with the most robust response observed in the aerosolized KL4 surfactant treatment group.
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Piglets treated with aerosolized KL4 surfactant had reduced tissue levels of interleukin–8 (IL-8), a key marker of lung inflammation, compared with control piglets (p < 0.03).
- Aerosolized KL4 surfactant was well tolerated and interfaced effectively with respiratory support.
Dr. Thomas F. Miller, Chief Operating Officer of Discovery Labs, commented, "We are excited to have the opportunity to present aerosolized KL4 surfactant to thought leaders in the European pediatric critical-care community, given the substantial unmet medical need for an aerosolized surfactant. Although our primary focus has been to pursue U.S. regulatory approval for SURFAXIN®, we have also advanced and are becoming recognized for our aerosolized medication delivery technologies in the field respiratory critical care."
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. Aerosolized KL4 surfactant is an investigational drug product and is not approved by the FDA or any other world health regulatory authority for use in humans. The CAG and AFECTAIR are investigational devices and are not cleared by the FDA or any other world health regulatory authority for use in humans.
About Discovery Labs' KL4 Surfactant and Aerosol Delivery Technology
Discovery Labs' novel KL4 surfactant is a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant, a substance produced naturally in the lung and essential for survival and normal respiratory function. Discovery Labs' aerosol technology platform includes the development of a proprietary capillary aerosolization generation (CAG) and a series of novel patient interfaces. The CAG has the potential to enable targeted upper respiratory or alveolar delivery of therapies for pulmonary applications and has been initially designed to produce high-quality, low-velocity aerosolized KL4 surfactant for intra-pulmonary delivery. The proprietary patient interface technology has the potential to simplify aerosol delivery to the patient receiving positive pressure ventilatory support.
SURFAXIN® is Discovery Labs' lead product and represents the first synthetic, peptide–containing surfactant that, if approved, will provide healthcare practitioners with an alternative therapy to the currently-approved, animal-derived surfactants that are standard of care today. The safety and efficacy of SURFAXIN for the prevention of RDS has previously been demonstrated in a comprehensive Phase 3 clinical program. Discovery Labs' SURFAXIN product is under active review by the US Food and Drug Administration for the prevention of RDS with a target action date of March 6, 2012 under the Prescription Drug User Fee Act (PDUFA).
AEROSURF® is Discovery Labs' initial aerosolized KL4 surfactant, and holds the promise to significantly expand the use of surfactant therapy in premature infants by potentially providing neonatologists with a means of administering KL4 surfactant to infants without the risks currently associated with administration of currently-approved surfactants, which require invasive endotracheal intubation and mechanical ventilation.
About The European Society for Paediatric Research Annual Meeting
Since its establishment in 1953, the European Paediatric Research Society (ESPR) has evolved from a club for paediatricians interested in research in children to improve child care to a 500-member strong organization. ESPR aims to promote pediatric research in Europe and encourage collaboration between different specialized fields of pediatrics to maintain pediatrics as a unified, scientifically orientated discipline. One of the ways ESPR achieves these goals is by organizing its own annual congress and co-organizing others. These prestigious pediatric meetings attract thousands of experts in all fields of pediatrics, providing them with networking opportunities and exposure to the latest available research, treatments and patient care.
About Discovery Labs
Discovery Laboratories, Inc. is a specialty biotechnology company with one focus – to create life-saving products for patients with respiratory disease and improve the standard of care for pulmonary medicine. 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, lyophilized and aerosol formulations. Discovery Labs is also developing its proprietary drug delivery technologies – capillary aerosol generator and novel patient interface adapters – to enable efficient, targeted upper respiratory or alveolar delivery of aerosolized KL4 surfactant. Discovery Labs believes that its proprietary technology 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 Discovery Labs' pre-clinical and clinical research and development programs, including the potential development of aerosolized KL4 surfactant and the proprietary patient interface technology, 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. Except as otherwise required by law, Discovery Labs undertakes no obligation to update or revise any forward-looking statements.