WARRINGTON, Pa., May 3, 2011 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO), announced that new data from a study using aerosolized KL4 surfactant demonstrated a significant improvement in lung function and survival when treating Acute Lung Injury (ALI) in a well-established preclinical model of this severe respiratory condition. The study was presented at the Pediatric Academic Societies (PAS) Annual Meeting, internationally recognized as the largest, most relevant medical meeting dedicated to pediatric research.
Dr. Mark C. Mammel, Professor of Pediatrics at the University of Minnesota, Director of Newborn Research & Education at Children's Hospital & Clinics of Minnesota and senior author of the study commented, "This study is important, as it is the first successful use of an aerosolized surfactant in a model of ALI to our knowledge. Discovery Labs' aerosolized KL4 surfactant allows us to contemplate non-invasive surfactant delivery as a means of potentially preventing disease progression and the need for aggressive critical care intervention that is typical for ALI patients today."
ALI is characterized by a decrease in lung function to a point where critical care intervention, including mechanical ventilation, is often required. ALI is associated with significant lung inflammation and a breakdown of natural surfactant. ALI can occur as a complication of several conditions, including severe respiratory viral and bacterial infections, certain major surgeries, sepsis, smoke inhalation and mechanical ventilator-induced lung injury (VILI). There are a significant number of patients at risk for ALI annually in the United States and there are no currently approved therapies other than supportive respiratory care.
The following study was presented: Aerosolized KL4 Surfactant Improves Gas Exchange and Survival in Spontaneously Breathing Piglets With HCl Induced Acute Lung Injury; Lampland, et al.
-
The objective of this study was to evaluate aerosolized KL4 surfactant in a piglet model with lung injury and subsequent reduced pulmonary function consistent with what is observed in humans with ALI. This preclinical model specifically assesses the potential impact of therapeutic intervention on lung function when severe lung injury is present. Piglets were randomized to receive either endotracheal bolus KL4 surfactant with extubation to continuous positive airway pressure (CPAP), aerosolized KL4 surfactant while on CPAP, or CPAP alone (control).
-
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.
-
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.
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 is also developing an aerosol delivery technology platform, including its proprietary capillary aerosolization generation (CAG) technology 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 increase the efficiency of aerosol delivery to the patient, reduce drug wastage, and result in more precise aerosol dosing.
Dr. Thomas F. Miller, Chief Operating Officer of Discovery Labs, commented, "Our team at Discovery is quite excited about this study and its very visible presentation at PAS. We are developing a unique aerosolized surfactant delivery system based on our proprietary technologies – KL4 surfactant, capillary aerosol generator and novel patient interface – and these component technologies were employed in Dr. Lampland's study. Aerosolized KL4 surfactant may allow the medical community to potentially address ALI in a completely new way."
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.
About The Pediatric Academic Societies Annual Meeting
The Pediatric Academic Societies (PAS) consists of the American Pediatric Society, the Society for Pediatric Research and the Ambulatory Pediatric Association. The PAS annual meeting is recognized as the largest, most prestigious meeting dedicated to pediatric research and education in the world and brings together scientists and physicians with expertise in all areas of pediatrics. More than 5,000 pediatric healthcare providers, including approximately 1,100 neonatologists attend this meeting annually.
About Discovery Labs
Discovery Laboratories, Inc. is a specialty 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. Discovery Labs is also developing its proprietary capillary aerosolization technology and novel patient interfaces, 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, 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.