Surfaxin LS Improves Pulmonary Function and Reduces Lung Inflammation in Established Model of Respiratory Distress Syndrome

Update: Surfaxin (lucinactant) Now FDA Approved - March 6, 2012

WARRINGTON, Pa., May 5, 2010 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO), announced that new data regarding Surfaxin LSTM (its novel, lyophilized KL4 surfactant dosage form) were presented at the 2010 Pediatric Academic Societies (PAS) Annual Meeting. The two studies presented demonstrate that Surfaxin LS improves lung function and oxygenation while attenuating lung inflammation in the preterm lamb model of respiratory distress syndrome (RDS). The preterm lamb model is recognized by the neonatal scientific community as an acceptable and well-established animal model of RDS in human preterm infants. The PAS Annual Meeting is internationally recognized as the largest, most relevant medical meeting dedicated to pediatric research.

Dr. Robert Segal, Senior Vice President and Chief Medical Officer of Discovery Labs, commented, "Surfaxin®, our lead product for RDS, has demonstrated a very favorable clinical profile and could potentially be approved by the FDA in 2011 for the prevention of RDS in premature infants. We have also been working with leading neonatology research centers to characterize the pharmacologic profile of our novel lyophilized KL4 surfactant, our second generation surfactant product candidate that we refer to as Surfaxin LS. Our strategy for Surfaxin LS development is to build upon the Surfaxin clinical experience to create a best-in-class product with improved preparation and administration flexibility with the potential to improve clinical performance by reducing potentially unfavorable peri-dosing events."

The following studies were presented:

Lyophilized KL4 Surfactant Sustains Oxygenation and Attenuates Inflammation Versus Animal- Derived Surfactant Replacement Therapy (SRT) in Ventilated-Hyperoxic Respiratory Distress (RDS) Model; Marla R Wolfson, et al.

* The objective of this study was to compare lyophilized KL4 surfactant to commercially available animal-derived surfactants with regard to improvements in pulmonary function (lung compliance, functional residual capacity and ventilator support requirements), integrity of lung tissue structure (assessed histologically), and the potential impact on inflammatory mediators in preterm lambs with RDS.

* Compared with untreated controls, treatment with lyophilized KL4 surfactant resulted in significant improvements in pulmonary function (p < 0.05), significantly better microscopic lung tissue structure (p < 0.05), and a significant reduction in two potent inflammatory mediators: interleukin (IL) – 8 and myeloperoxidase (p < 0.05). Significant improvements in pulmonary function were observed in lambs treated with the animal-derived surfactants, Survanta® and Curosurf®, compared with controls (p < 0.05); however, oxygenation was significantly improved in lambs treated with lyophilized KL4 surfactant compared with those treated with comparator animal-derived surfactants (p < 0.05).

* The investigators concluded that lyophilized KL4 surfactant improved oxygenation and attenuated lung inflammation in preterm lambs with RDS to a greater extent than animal-derived surfactants. These data suggest that lyophilized KL4 surfactant may mitigate the progression of RDS to bronchopulmonary disease (BPD) and, as a lyophilized formulation, may expand flexibility of use and patient access.

Comprehensive Comparison of Poractant Alfa and Lyophilized KL4 Surfactant in a Preterm Lamb Model of Respiratory Distress Syndrome; Arlin B. Blood, et al

* The objective of this study was to compare the effects of lyophilized KL4 surfactant and poractant alfa (Curosurf) on pulmonary function and peri-dosing associated effects of surfactant administration in preterm lambs with RDS.

* Both surfactants significantly improved pulmonary function (p < 0.05). However, lambs treated with lyophilized KL4 surfactant required significantly lower mechanical ventilator pressures to maintain pulmonary function compared with Curosurf-treated lambs (p < 0.05).

* In contrast to lambs treated with lyophilized KL4 surfactant, lambs treated with Curosurf experienced significant reductions in heart rate and rapidly increased brain oxygenation during the peri-dosing period (p < 0.05).

* The investigators concluded that the lyophilized KL4 surfactant may enable ventilation at lower mean airway pressures which may reduce the incidence of chronic lung disease and as such may be an effective substitute for the currently marketed surfactant products.

Dr. Segal continued, "These two studies indicate that Surfaxin LS favorably improves lung physiology and attenuates lung inflammation, which may reduce the risk for chronic lung disease. Additionally, we believe that Dr. Blood's observations with respect to heart rate and brain oxygenation suggest that lyophilized KL4 surfactant may also support a reduction in potentially unfavorable peri-dosing events following surfactant administration. These observations, coupled with the flexibility and anticipated ease of use of a reconstituted, lyophilized product represent a potentially meaningful improvement in this class of drugs relative to currently marketed surfactants. We look forward to continued advancement of the Surfaxin LS program."

About SURFAXIN and SURFAXIN LS

Surfaxin and Surfaxin LS are investigational products that have not been approved by the U.S. Food and Drug Administration or any other world health regulatory authority. The study results listed above include information that may be of interest to healthcare practitioners; however, the clinical relevance of these results has not been fully established and further scientific investigation may be warranted.

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. For more information, please visit our website at <http://www.globenewswire.com/newsroom/ctr?d=190906&l=12&a=www.Discoverylabs.com&u=http%3A%2F%2Fwww.discoverylabs.com%2F> www.Discoverylabs.com<http://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.

CONTACT: Discovery Laboratories, Inc. John G. Cooper, EVP and Chief Financial Officer 215-488-9300

Source: Discovery Laboratories, Inc.

 

 

 

Posted: May 2010

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