WARRINGTON, Pa., Dec. 7, 2010 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO), today announced that new Aerosurf® data in a study employing the well-established preterm lamb model of respiratory distress syndrome (RDS) were presented at the 2010 Annual Hot Topics in Neonatology congress in Washington, DC. Key observations from this preclinical study, conducted at the Temple University School of Medicine, suggest that Aerosurf may improve lung function and reduce the inflammatory response associated with lung injury and the development of chronic lung disease in a dose-dependent fashion and at reduced dose exposures compared with previous studies in this non-clinical model. Aerosurf is an aerosolized form of Discovery Labs' proprietary KL4 surfactant.
Dr. Marla R. Wolfson, Study Principal Investigator and Professor, Departments of Physiology, Pediatrics, and Medicine at the Temple University School of Medicine, commented, "The potential benefits of Aerosurf suggested by the results of this latest study are quite promising, particularly in light of high rates of CPAP failure in recently published clinical trials. This novel approach will potentially allow for non-invasive administration of surfactant to improve lung function. In this most recent assessment, we observed meaningful improvement in lung function and lung structural integrity, as well as reduced lung tissue inflammatory marker levels, in surfactant deficient preterm lambs following relatively low exposures of aerosolized KL4 surfactant."
The well-established preterm RDS lamb model is the most relevant in vivo system to study the pathophysiology and treatment of RDS because it closely resembles the development, structure, and function of the respiratory system of preterm humans. In this study, twenty-two preterm lambs were randomized to receive CPAP alone or CPAP plus either 10, 20, 30 or 90 minutes of Aerosurf exposure at a maintained CAG output rate of 22.5 mg of total phospholipid per minute. Lung function, lung structure and lung tissue inflammatory markers were assessed across groups. Key observations from this preclinical study include:
- Treatment with Aerosurf resulted in a dose-dependent improvement in lung function and decrease in lung interleukin-8, an established marker of respiratory inflammation, with marked differences following 20 minutes of aerosol exposure and with no further improvement following 30 and 90 minutes of exposure.
- Improvement in oxygenation was observed to a greater degree in the 10, 20, and 30 minute dosing groups compared with CPAP alone or the 90 minute dosing group.
- Treatment with Aerosurf preserved lung structural integrity in all Aerosurf exposure groups.
- Aerosurf appeared to be well tolerated and interfaced effectively with CPAP respiratory support
Dr. Russell Clayton, Discovery Labs' Vice President of Research and Development, commented, "These data represent an important step forward in our understanding of the dose–response relationship for our aerosolized KL4 surfactant and will help guide next steps in Aerosurf development. The observations from this study suggest that as little as 20 minutes of Aerosurf exposure could potentially yield a favorable effect on lung function as well as a reduction of inflammatory mediators in the lung. Reduced dosing times effectively translate to more efficient use of healthcare provider resources, a critical consideration for new respiratory therapies."
In order to avoid endotracheal intubation and the risk of lung damage, CPAP is increasingly being employed by medical practitioners to support preterm infants with respiratory insufficiency. However, avoiding endotracheal intubation in these infants precludes the timely administration of surfactant. Recent multi-center neonatal trials have demonstrated that a large proportion of preterm infants fail early CPAP therapy and require subsequent rescue with endotracheal intubation, and mechanical ventilation, each with their attendant medical risks, and then will often receive delayed surfactant administration. The neonatal, pediatric, and adult critical care medical communities recognize the substantial unmet need and potential for an aerosolized lung surfactant, delivered non-invasively, to address a wide array of respiratory disorders.
Aerosurf is an aerosolized form of Discovery Labs' proprietary KL4 surfactant created via proprietary capillary aerosol generating (CAG) technology. Discovery Labs' KL4 surfactant is a completely synthetic, peptide-containing surfactant designed to closely mimic the essential attributes of human lung surfactant. The safety and efficacy of Discovery Labs' lead KL4 surfactant product, Surfaxin® for neonatal RDS, has been previously demonstrated in a large multi-national Phase 3 clinical program. Surfaxin is the subject of a Complete Response letter from the U.S. Food and Drug Administration (FDA) and Discovery Labs expects to submit a complete response to the FDA in the first quarter of 2011. If approved, Surfaxin would be the first synthetic, peptide-containing surfactant for commercial use in neonatal medicine.
Data from previous pre-clinical and clinical studies using aerosolized KL4 surfactant were presented at the Pediatric Academic Societies (PAS) 2006 and 2007 and at the 2008 European Society for Pediatric Research Annual Meetings. In these studies, aerosolized KL4 surfactant maintained its chemical structure and essential functional activity post-aerosolization. In addition, in a recent pilot study, aerosolized KL4 surfactant delivered via a commercially available nebulizer was observed to be safe and well tolerated in human preterm infants.
Both Surfaxin and Aerosurf are investigational drugs that have not been approved by the FDA or any other world health regulatory authorities. The non-clinical nature of the studies mentioned above may be of interest to scientists and medical practitioners but the clinical relevance of this information has not been determined.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing 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 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.
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 and related regulatory efforts, 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.
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