WARRINGTON, Pa., Jan. 5, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc.
(Nasdaq:DSCO) announces the publication of results from its Phase 2 clinical
trial of Surfaxin(r) for the prevention and treatment of Bronchopulmonary
Dysplasia (BPD) in Pediatrics, a premier medical journal for pediatric
critical-care healthcare practitioners. BPD is a chronic, debilitating lung
disease typically affecting premature infants who received treatment for
Respiratory Distress Syndrome (RDS). The results from the study indicated that
administration of additional doses of Surfaxin following standard SRT treatment
for acute RDS may represent a novel therapeutic option for infants at risk for
developing BPD. Presently, there are no approved pharmaceutical therapies for
BPD.
These results appear in the following manuscript published in the January issue
of Pediatrics:
* A Pilot Randomized, Controlled Trial of Later Treatment with
a Peptide-Containing, Synthetic Surfactant for the Prevention
of Bronchopulmonary Dysplasia (Laughon et al. Pediatrics
2009;123 89-96)
Robert J. Capetola, President and CEO of Discovery Labs commented, "We are
extremely pleased that Pediatrics has published these data and made them
available to the medical community. We believe that these data further validate
the pharmacology of our KL-4 surfactant and support our continued development of
our technology platform to address a broad range of unmet medical needs in
pulmonary medicine."
Discovery Labs conducted a Phase 2 clinical trial to evaluate the safety and
potential efficacy of Surfaxin in infants at risk for BPD. The clinical trial
enrolled 136 premature infants that were randomized to receive, in addition to
standard of care, either Surfaxin standard dose (175 mg/kg), Surfaxin low dose
(90 mg/kg), or sham air as a control. In this pilot estimation study, infants
treated with the Surfaxin standard dose, as compared to those in the control
group experienced a lower incidence of death or BPD (58% vs. 66%), a higher
survival rate through 36 weeks post-menstrual age (89% vs. 84%), and fewer days
on mechanical ventilation. No meaningful conclusions could be drawn from the
Surfaxin low dose treatment group, likely due to this group containing infants
with more pre-existing medical risk conditions.
Dr. Matthew Laughon, Assistant Professor, Department of Pediatrics, Division of
Neonatal-Perinatal Medicine, The University of North Carolina at Chapel Hill,
commented, "The data from this Phase 2 estimation trial support additional
trials to evaluate the potential of Surfaxin as a therapeutic option for the
prevention of BPD. BPD represents one of the most challenging clinical problems
we face in neonatology. Extremely low birth weight infants, particularly those
that require mechanical ventilation, are at risk for this debilitating
disorder."
BPD is associated with surfactant deficiency and is diagnosed when premature
infants require mechanical ventilation or supplemental oxygen at 36 weeks
post-menstrual age. Premature infants are often born with a lack of natural lung
surfactant and are unable to absorb sufficient oxygen to survive, resulting in
RDS. These infants often require endotracheal intubation to administer one of
the currently-available, animal-derived surfactants (usually within the first
hours of birth) and to provide respiratory support via mechanical ventilation.
Unfortunately, many infants relapse following initial SRT and require
reintubation and prolonged mechanical ventilation as well as supplemental
oxygen, which increases the risk of developing BPD. Discovery Labs believes that
BPD may be prevented with repeated doses of Surfaxin administered after the
initial RDS SRT treatment (on day 1 or 2 of life) to improve the clinical
outcome of these infants.
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 the medical journal, Pediatrics
Pediatrics, the official journal of the American Academy of Pediatrics,
publishes papers on original research or observations and special feature
articles in the field of pediatrics. The Executive Board and Officers of the
American Academy of Pediatrics select articles that appear in Pediatrics. The
American Academy of Pediatrics is an organization of 60,000 primary care
pediatricians, pediatric medical subspecialists, and pediatric surgical
specialists dedicated to the health, safety, and well-being of infants,
children, adolescents, and young adults. The Academy is committed to the
attainment of optimal physical, mental, and social health for all infants,
children, adolescents and young adults.
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 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.
Discovery Labs' lead product from its SRT pipeline is SURFAXIN(r) for the
prevention of Respiratory Distress Syndrome in premature infants. The U.S. Food
and Drug Administration (FDA) has established April 17, 2009 as its target date
to complete its review of this new drug application (NDA) and potentially grant
marketing approval for this product. SURFAXIN is also being developed for other
neonatal and pediatric indications. AEROSURF(r), 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' response to the
May 2008 Approvable Letter for Surfaxin 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), which could
cause Discovery Labs to cut back or suspend its development activities or
potentially cease operations; 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, 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 technology; 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.
-0-
CONTACT: Discovery Laboratories, Inc.
Investor Relations
Lisa Caperelli
215-488-9413
