Discovery Laboratories, Inc. (Nasdaq:DSCO), Warrington, Pa., has
announced 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, visit http://www.Discoverylabs.com or call
215/488-9413.
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.
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