September 3, 2008
Discovery Labs’ Aerosolized KL-4 Surfactant Selected for Evaluation in Phase 2a Cystic Fibrosis Clinical Trial; First Clinical Trial Evaluating Aerosolized KL-4 Surfactant in Patients With Cystic Fibrosis
WARRINGTON, Pa., Sept. 3, 2008 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) announces that its proprietary, aerosolized KL-4 surfactant has been selected for a Phase 2a clinical trial in patients with Cystic Fibrosis (CF). The trial is being conducted as an investigator-initiated study under the direction of Dr. Scott H. Donaldson at The University of North Carolina and is funded primarily through a grant provided by the Cystic Fibrosis Foundation.
The trial is designed as a double-blind, randomized study to evaluate whether Discovery Labs' aerosolized KL-4 surfactant is safe and well tolerated in patients with mild to moderate CF lung disease. In addition, the short-term effectiveness of aerosolized KL-4 will be assessed. UNC's Investigational New Drug (IND) Application for this study was submitted to the United States Food and Drug Administration and went into effect in May 2008. Patient enrollment is expected to begin this fall.
CF is characterized by a genetic mutation that produces thick, viscous mucus that is difficult to clear from the airways of the lung and typically leads to life-threatening respiratory infections. Preclinical and exploratory clinical studies suggest that therapeutic surfactants may improve lung function by loosening mucus and making it easier to clear.
Dr. Scott H. Donaldson, Assistant Professor of Medicine at the University of North Carolina and study's principal investigator, commented, "My colleagues and I are committed to working with the Cystic Fibrosis Foundation to support the development of new therapies for CF patients. Refinement of our understanding of the pathogenesis of CF lung disease has led us to believe that aerosolized surfactant therapies could advance the management of CF. With its unique attributes, including its ability to be aerosolized and expected effects on mucus clearance, KL-4 synthetic surfactant may represent an important new therapy for CF. Accordingly, I believe that an aerosolized surfactant could complement the current standard of care."
Dr. Charles Cochrane, co-founder and Professor Emeritus of The Scripps Research Institute and inventor of Discovery Labs' KL-4 technology, commented, "KL-4 surfactant was developed to expand the medical application of therapeutic surfactants beyond their current applications for neonates only. Recently published and ongoing scientific investigations continue to identify potentially unique attributes of KL-4 surfactant, including anti-inflammatory and anti-microbial properties that add to the primary KL-4 surfactant function of establishing and maintaining expansion of the lung. I am delighted that KL-4 surfactant will now be studied in patients with cystic fibrosis."
CF is a life-threatening genetic disease affecting the respiratory and other body systems in approximately 30,000 patients in the United States and nearly 70,000 worldwide. It is the most common, life-threatening genetic disorder in the United States, occurring in approximately one in every 3,500 live births. To date, treatment of pulmonary conditions in CF primarily includes antibiotics to address lung infection and airway clearance therapies to break down and remove mucus. Life expectancy for CF has more than doubled in the past 25 years to age 37, due to significant advances in research and care.
About Discovery Labs
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' technology produces a peptide-containing synthetic surfactant (KL-4 surfactant) that is structurally similar to pulmonary surfactant. 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 KL-4 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.
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 respond, if at all, to the recent approvable letter for Surfaxin within the anticipated timeline and the response, when filed, may not satisfy the FDA; the FDA or other regulatory authorities may not accept, or may withhold or delay consideration of, any applications that Discovery Labs may file for its products, or may not approve any such applications or may limit marketing of such products to particular indications or impose unanticipated label limitations; 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 raise additional capital or enter into additional collaboration agreements (including strategic alliances for development or commercialization of SRT); Discovery Labs' lengthy and costly research and development programs, including pre-clinical studies, clinical trials and other efforts to gain regulatory approval for any of its products, including Surfaxin, may not progress or may be subject to potentially significant delays or regulatory holds, or fail; Discovery Labs or its contract manufacturers or materials suppliers may be unable to successfully manufacture adequate supplies of its drug product or drug substances when needed or in amounts sufficient to meet demand; Discovery Labs 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 profitably develop and market its products; 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. Investor Relations Lisa Caperelli 215-488-9413