WARRINGTON, Pa., June 17, 2014 /PRNewswire/ -- Discovery
Laboratories, Inc. (NASDAQ: DSCO) today announced that it has
been awarded the final $1.9 million
of a $2.4 million Fast Track Small
Business Innovation Research (SBIR) Grant from the National Heart,
Lung, and Blood Institute (NHLBI) of the National Institutes of
Health (NIH). This award will provide support for the ongoing phase
2a clinical trial for AEROSURF®, Discovery Labs' investigational
combination drug/device product. AEROSURF is in development to
provide KL4 surfactant therapy through nasal continuous positive
airway pressure (nCPAP) for respiratory distress syndrome (RDS) in
premature infants. Discovery Labs was notified in 2010 that it was
eligible for consideration under this grant program, and previously
received $580,000 to support
development activities related to its capillary aerosol generator
technology. The company expects to utilize the $1.9 million during 2014.
AEROSURF could potentially allow for the administration of KL4
surfactant to premature infants without invasive endotracheal
intubation, and may enable the treatment of a significantly greater
number of premature infants who could benefit from surfactant
therapy but are currently not treated.
Discovery Labs is enrolling patients into a phase 2a clinical
study to evaluate the safety and tolerability of aerosolized KL4
surfactant administered to premature infants 29 to 32 weeks
gestational age who are receiving nCPAP for respiratory distress
syndrome (RDS), compared to infants receiving nCPAP alone. This
study is as an escalating dose study evaluating three dose levels
of aerosolized KL4 surfactant and is expected to be completed in
the third quarter of 2014.
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 a 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.
Forward-Looking Statements
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.