WARRINGTON, Pa., May 4, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) announced that data from a preclinical study using KL4 surfactant demonstrated a favorable physiologic benefit and subsequent survival impact on treating Acute Lung Injury (ALI) in a well-established model for this severe respiratory condition. Discovery Labs' novel proprietary KL4 surfactant technology produces 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. The data were presented at the Pediatric Academic Societies Annual Meeting, which is internationally recognized as the largest, most relevant medical meeting dedicated to pediatric research.
Acute Lung Injury is associated with conditions that either directly or indirectly injure the lung to a point where critical care intervention, including mechanical ventilation, is required. ALI and related complications are typically associated with respiratory infections, including influenza and pneumonia, certain major surgeries or illnesses, inhalation or traumatic injury and mechanical ventilator-induced lung injury (VILI). ALI is a condition characterized by severe respiratory compromise and release of inflammatory mediators that can break down endogenous surfactant.
The results from the study "Improved Gas Exchange and Survival in Spontaneously Breathing Newborn Pigs with Hydrochloric Acid Induced Severe Acute Lung Injury Treated with KL4 Surfactant" were presented by Dr. Anna M. Zimmerman from the University of Minnesota. The objective of the study was to examine the effectiveness of KL4 surfactant in treating newborn piglets with severe ALI. After inducing ALI, the piglets were randomized to receive either treatment with KL4 surfactant and continuous positive airway pressure (CPAP) or CPAP alone as a control. The results demonstrated that piglets treated with KL4 surfactant experienced a statistically significant improvement in oxygenation (p < 0.001), as well as better structural integrity of the lung tissue (p < 0.05) and improved survival (p < 0.05) throughout the evaluation period.
Robert Segal, M.D., Senior Vice President and Chief Medical Officer of Discovery Labs, commented, "These results are very promising and support clinical studies of KL4 surfactant in ALI. We have been particularly interested in assessing the potential impact of KL4 surfactant in ALI and Acute Respiratory Failure (ARF), and are currently enrolling patients in a Phase 2 clinical trial for ARF. We believe that our KL4 technology platform has the potential to provide for a novel and much needed treatment for patients with severe respiratory infections that require critical care intervention following exposure to pathogens, such as influenza and respiratory syncytial virus. In light of the recent and very visible concerns regarding the influenza pandemic risk, it is clear that new therapeutic approaches to address acute injury of the lung are needed."
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.
Development programs for KL4 Surfactant addressing respiratory infections
Discovery Labs is conducting a Phase 2 clinical trial using its liquid KL4 surfactant, Surfaxin(r), in children up to two years of age suffering from Acute Respiratory Failure (ARF). ARF typically occurs following a serious respiratory infection, such as respiratory-syncytial virus or influenza, which leads to impairment in lung function, reduced levels of functional surfactant, and the need for endotracheal intubation and mechanical ventilation. There are currently no medications approved for this debilitating condition.
Discovery Labs is also developing its aerosolized KL4 surfactant as a potential effective measure to treat patients at risk for ALI. Preclinical studies are ongoing, employing Discovery Labs' KL4 surfactant and Capillary Aerosolization Technology in models of respiratory failure. Discovery Labs' novel Capillary Aerosolization has the potential to enable targeted upper respiratory, airway, or alveolar delivery of therapies for pulmonary applications.
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 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 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. Discovery Labs is focused initially on developing its KL4 surfactant pipeline to build a pediatric franchise that will potentially address several respiratory conditions affecting neonates and young children. 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 are: risks relating to the rigorous regulatory requirements required for approval of any drug or drug-device combination products that Discovery Labs may develop, including that: (i) Discovery Labs and the U.S. Food and Drug Administration (FDA) will not be able to agree on the matters raised by the FDA in its Complete Response letter dated April 17, 2009, or the FDA may require Discovery Labs to conduct significant additional activities to potentially gain approval of Surfaxin, if ever (ii) the FDA or other regulatory authorities may not accept or may withhold or delay consideration of any of Discovery Labs' applications, or may not approve or may limit approval of Discovery Labs' products to particular indications or impose unanticipated label limitations, and (iii) changes in the national or international political and regulatory environment may make it more difficult to gain FDA or other regulatory approval; risks relating to Discovery Labs' research and development activities, including time-consuming and expensive pre-clinical studies, clinical trials and other efforts, which may be subject to potentially significant delays or regulatory holds, or fail; risks relating to Discovery Labs' ability to develop and manufacture drug products and capillary aerosolization systems for clinical studies, and, if approved, for commercialization of drug and combination drug-device products, including risks of technology transfers to contract manufacturers and problems or delays encountered by Discovery Labs, its contract manufacturers or suppliers in manufacturing drug products, drug substances and capillary aerosolization systems on a timely basis or in an amount sufficient to support Discovery Labs' development efforts and, if approved, commercialization; risks that (a) market conditions, the competitive landscape or otherwise, may make it difficult to launch and profitably sell products, (b) Discovery Labs may be unable to identify potential strategic partners or collaborators to market its products, if approved, in a timely manner, if at all, and (c) Discovery Labs' products will not gain market acceptance by physicians, patients, healthcare payers and others in the medical community; the risk that Discovery Labs or its strategic partners or collaborators will not be able to attract or maintain qualified personnel; the risk that Discovery Labs will not be able in a changing financial market to raise additional capital or enter into strategic alliances or collaboration agreements, or that the ongoing credit crisis will adversely affect the ability of Discovery Labs to fund its activities, or that additional financings could result in substantial equity dilution; the risk that Discovery Labs will not be able to access credit from its committed equity financing facilities, or that the share price at which Discovery Labs may access the facilities from time to time will not enable Discovery Labs to access the full dollar amount potentially available under the facilities; the risk that Discovery Labs will be unable to maintain The Nasdaq Global Market listing requirements, causing the price of Discovery Labs' common stock to decline; the risk that recurring losses, negative cash flows and the inability to raise additional capital could threaten Discovery Labs' ability to continue as a going concern; the risks that Discovery Labs may be unable to maintain and protect the patents and licenses related to its products, or other companies may develop competing therapies and/or technologies, or health care reform may adversely affect Discovery Labs; risks of legal proceedings, including securities actions and product liability claims; risks relating to reimbursement and health care reform; and other risks and uncertainties 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.