WARRINGTON, Pa., Oct. 1, 2014 /PRNewswire/ -- Discovery
Laboratories, Inc. (Nasdaq: DSCO) today announced that the
Company has been awarded a Phase II Small Business Innovation
Research Grant (SBIR) valued at up to $3.0
million from the National Institute of Allergy and
Infectious Diseases (NIAID) of the National Institutes of Health
(NIH) to support the development of the Company's aerosolized
KL4 surfactant as a medical countermeasure to mitigate
acute and chronic/late-phase radiation-induced lung injury. The
company has been awarded $1.0
million, and over the next three years may be awarded up to
an additional $2.0 million as part of
this grant. This program will be conducted in conjunction with
Melpo Christofidou-Solomidou, Ph.D., a leading expert in novel
antioxidant approaches to acute and chronic lung diseases from the
University of Pennsylvania's Perelman
School of Medicine. In fiscal year 2010, the Perelman School of
Medicine received $583 million in
support for its research activities from extramural sponsors,
including $408 million from the
National Institutes of Health, ranking third in the nation among
all academic medical institutions.
"While we remain focused on respiratory distress syndrome in
premature infants, we believe that our proprietary KL4
surfactant also has the potential to address a number of other lung
diseases and complications, including certain acute lung injuries,"
commented John G. Cooper, Discovery
Lab's President and Chief Executive Officer. "The NIH has
previously provided Discovery Labs funding to assess these
potential opportunities, and based on the encouraging results of
that preliminary work, has provided additional funding to continue
research in this area. Radiation-induced pulmonary injury is a
common and complicated manifestation of radiation exposure, and we
look forward to developing data that may help define the role of
KL4 surfactant in protecting irradiated lungs."
The Company believes that its proprietary KL4
surfactant may have utility in a variety of radiation-induced lung
injuries, a common term referencing not only damage to the lungs
occurring as a result of a radiological accident or terrorism
threat agent, but also lung damage occurring as a result of
radiation therapy as a treatment modality for a number of thoracic
malignancies. Studies have suggested that radiation-induced
pneumonitis may occur in up to 15 percent of patients receiving
radiation therapy for lung cancer.
KL4 surfactant is a novel synthetic,
peptide-containing surfactant designed to closely mimic the
essential attributes of human lung surfactant. Discovery Labs
is currently evaluating aerosolized KL4 surfactant in an
ongoing phase 2a clinical program to assess safety and tolerability
of aerosolized KL4 surfactant delivered to premature
infants receiving nasal continuous positive airway pressure (nCPAP)
for respiratory distress syndrome (RDS).
Government support and interest in Discovery Labs' aerosolized
KL4 surfactant program stems from the passing of the
Project Bioshield Act of 2004 and the Pandemic & All-Hazards
Preparedness Act of 2006 by the U.S. Congress. Both Acts
encourage private sector development of medical countermeasures
against chemical, biological, radiological, and nuclear terrorism
threat agents, and pandemic influenza, and provide a mechanism for
federal acquisition of such countermeasures.
About Discovery Labs
Discovery Laboratories, Inc. is a
specialty biotechnology company focused on advancing a new standard
in respiratory critical care. Discovery Labs' technology
platforms include its novel proprietary KL4 surfactant,
a synthetic, peptide-containing surfactant that is structurally
similar to pulmonary surfactant, and proprietary drug delivery
technologies being developed to enable efficient delivery of
aerosolized KL4 surfactant. Discovery Labs'
strategy is initially focused on neonatology and improving the
management of respiratory distress syndrome (RDS) in premature
infants. Discovery Labs believes that its RDS product
portfolio has the potential to become the new standard of care for
RDS and, over time, to enable the treatment of a significantly
greater number of premature infants who could benefit from
surfactant therapy but are currently not treated. SURFAXIN®
(lucinactant), Discovery Labs' first KL4
surfactant-based product, is the only available synthetic
alternative to animal-derived surfactants approved by the U.S. Food
and Drug Administration (FDA). Full prescribing information can be
found at http:///www.surfaxin.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 risks and uncertainties that could cause actual results
to differ materially from the statements made. Examples of such
risks and uncertainties, including those affecting Discovery Labs'
ability successfully to complete its development programs and
realize the potential benefits of its RDS product portfolio, are
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. Any forward-looking
statement in this release speaks only as of the date on which it is
made. Discovery Labs assumes no obligation to update or revise any
forward-looking statements.
SOURCE Discovery Laboratories, Inc.