July 29, 2008
Discovery Labs KL-4 Surfactant Anti-Inflammatory Data Published in Pediatric Research
WARRINGTON, Pa., July 29, 2008 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO), announces the publication in Pediatric Research of data from a pre-clinical research study conducted at the Nemours Research Lung Center, DuPont Hospital for Children. The data showed that KL-4 surfactant reduced the inflammatory response and improved cell survival and function in a human lung cell-culture injury model. Pediatric Research is a prominent peer reviewed journal that publishes results of significant clinical and laboratory studies intended for research-oriented pediatricians and faculty.
Respiratory inflammation is a primary component of many lung diseases. It is well established that inflammatory mediators in the lung damage the lung cells that make surfactant. Surfactants are compositions produced naturally in the lungs and are essential for breathing. Discovery Labs is focused on diseases in which inflammation or endogenous surfactant degradation plays an integral part in development of respiratory lung diseases, such as Acute Lung Injury, Acute Respiratory Failure, Bronchopulmonary Dysplasia, and Respiratory Distress Syndrome, Cystic Fibrosis, Asthma, and Chronic Obstructive Pulmonary Disorder.
The manuscript published in Pediatric Research is: Surfaxin (KL-4 surfactant) Protects Human Airway Epithelium from Hyperoxia (Zhu et al.) Pediatric Research. 64(2): 154-158, August 2008.Conducted under the direction of Drs. Zhu, Miller, Chidekel, and Shaffer, the study examined whether KL-4 surfactant reduced markers of inflammation, damage and remodeling in human airway epithelia cells exposed to high concentrations of oxygen (hyperoxia), which causes lung injury. The study assessed the impact of exogenous surfactants, including KL-4 surfactant (Surfaxin(r)), on hyperoxic-induced lung injury in an in-vitro cell-culture model. The results concluded that KL-4 surfactant reduced inflammation and cell injury, resulting in improved cell survival and function compared with both a saline control as well as beractant (Survanta(r)), an animal-derived surfactant and currently the most frequently prescribed surfactant in the United States. Preliminary results from this study were previously presented at the Pediatric Academic Societies annual meeting in May 2007 and the European Society for Paediatric Research annual meeting in October 2007.
Dr. Thomas H. Shaffer, Director, Nemours Research Lung Center, commented, "These data are quite compelling and support a potentially novel mechanism of KL-4 surfactant, which may be clinically relevant in the treatment of several respiratory disorders where lung inflammation plays a central role."
Surfaxin(r), an investigational drug, is the subject of an Approvable Letter from the FDA for the prevention of Respiratory Distress Syndrome in premature infants. The publication listed above includes information that may be of interest to healthcare practitioners; however, the clinical relevance of this information has not been established.
About Discovery Labs and its Novel, KL-4 Surfactant Technology
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' KL-4 technology produces a peptide-containing synthetic surfactant that is structurally similar to pulmonary surfactant. KL-4 is a 21-amino acid peptide with structural similarities to pulmonary surfactant protein B (SP-B), the surfactant protein most important for normal respiratory function. KL-4 surfactant technology has the potential to be precisely formulated as a liquid instillate or aerosol. 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.
About Pediatric Research
Pediatric Research presents the work of leading authorities in pediatric pulmonology, neonatology, cardiology, hematology, neurology, developmental biology, fetal physiology, endocrinology and metabolism, gastroenterology, and nutrition. Directed to research-oriented pediatricians and faculty, the journal publishes the results of significant clinical and laboratory studies. The Journal includes original peer-reviewed articles, abstracts of society meetings, state-of-the-art reviews, as well as supplements on pediatric health issues. Pediatric Research is the official publication of the American Pediatric Society, the European Society for Paediatric Research, and the Society for Pediatric Research.
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 may be unable to timely respond, if at all, to the May 2008 approvable letter for Surfaxin; Discovery Labs may not succeed in the FDA or other regulatory agency review process, including that such regulatory authority may not approve the marketing and sale of Surfaxin or any other drug product that Discovery Labs may develop, or such regulatory agency may further delay and/or limit marketing of Surfaxin or any of Discovery Labs' drug products by indication or impose other label limitations; Discovery Labs may not be able to raise additional capital or enter into additional collaboration agreements (including strategic alliances for development or commercialization of SRT); 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 profitably develop and market its products; Discovery Labs' significant, time-consuming and costly research and development activities, including pre-clinical studies, clinical trials and other efforts to gain regulatory approval for any of its products may not progress or may be subject to potentially significant delays or regulatory holds, or fail; Discovery Labs may be unable to successfully manufacture or provide adequate supplies of drug substances on a timely basis; Discovery Labs may be unable to transfer its manufacturing technology to third-party contract manufacturers or its contract manufacturers or any of its materials suppliers may encounter problems manufacturing drug products or drug substances on a timely basis or manufacture in amounts sufficient to meet demand; Discovery Labs and its collaborators 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 maintain and protect the patents and licenses related to its SRT; 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.
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CONTACT: Discovery Laboratories, Inc. Lisa Caperelli, Investor Relations 215-488-9413