WARRINGTON, Pa., Jan. 19, 2010 (GLOBE NEWSWIRE) -- Research recently published in the Proceedings of the National Academy of Sciences indicates that a naturally occurring phospholipid in pulmonary surfactant, palmitoyl-oleoyl-phosphatidylglycerol (POPG), suppresses respiratory syncytial virus (RSV) infection and associated inflammation in both in vitro and in vivo models (Numata et al, Proc Nat Acad of Sci, Dec 09). This important research, along with commentary from Discovery Labs, was featured in the January 14, 2010 issue of SciBX, a weekly publication from Nature Publishing Group and BioCentury Publications. SciBX requested that Discovery Labs provide expert commentary regarding this research because POPG is a key active pharmaceutical ingredient in Discovery Labs' novel, KL4 Surfactant Technology.
The research demonstrates that POPG inhibits the spreading of RSV in human airway cells, prevents damage to human airway cells exposed to RSV, and blocks RSV infection in mice exposed to RSV. POPG appears to directly attach and interact with the virus, thus inhibiting the attachment of the virus to human airway cells. In addition, POPG inhibits production of important inflammatory cytokines interleukin (IL) -6 and IL-8 produced by human airway cells consistent with previously-reported results of in vitro and in vivo studies regarding Discovery Labs' KL4 surfactant (Zhu et al; Pediatric Research, 2008; Wolfson et al; Pediatric Research, 2008).
Robert Segal, M.D., Senior Vice President and Chief Medical Officer of Discovery Labs, commented, "This research is an important step towards defining the role of POPG as a potential new therapy to address viral lung infections. We believe that our synthetic, peptide-based KL4 surfactant, which contains relatively high concentrations of POPG, is the only surfactant in which POPG is an active pharmaceutical ingredient. We are encouraged that data from leading academic centers continue to support our position that KL4 surfactant may play a unique role in addressing several, debilitating respiratory disorders."
RSV is the most common cause of hospitalization for respiratory tract infection in young children and is a leading cause of Acute Respiratory Failure (ARF) in this age group. RSV is also a significant cause of morbidity and mortality in adult patients with compromised respiratory function including those diagnosed with asthma and chronic obstructive pulmonary disease.
Discovery Labs is conducting a Phase 2 clinical trial to determine whether its drug candidate, Surfaxin®, improves lung function and reduces duration and related risk of mechanical ventilation in children up to two years of age diagnosed with ARF following exposure to a pathogen such as RSV or influenza (including the H1N1 serotype). Top-line results are expected to be available in the first half of 2010. Discovery Labs is also currently conducting preclinical studies employing its KL4 surfactant and novel Capillary Aerosolization Technology to explore potential application of aerosolized surfactant for other serious respiratory conditions, including Acute Lung Injury (ALI), in both pediatric and adult populations.
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. 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: (a) Discovery Labs and the U.S. Food and Drug Administration (FDA) or other regulatory authorities will not be able to agree on the matters raised during regulatory reviews, or Discovery Labs may be required to conduct significant additional activities to potentially gain approval of its product candidates, if ever, (b) 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 (c) 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 (i) 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, and (ii) the need for sophisticated and extensive analytical methodologies, including an acceptable biological activity test, if required, as well as other quality control release and stability tests to satisfy the requirements of the regulatory authorities; 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; the risk that Discovery Labs may be unable to identify potential strategic partners or collaborators to develop and commercialize its products, if approved, in a timely manner, if at all; 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 (CEFFs), or that the minimum share price at which Discovery Labs may access the CEFFs from time to time will prevent Discovery Labs from accessing the full dollar amount potentially available under the CEFFs; the risk that Discovery Labs or its strategic partners or collaborators will not be able to retain, or attract, qualified personnel; the risk that Discovery Labs will be unable to regain compliance with The Nasdaq Global Market listing requirements prior to the expiration of the grace period currently in effect, which could cause 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 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.