Discovery Laboratories, Inc.
DSCO, a specialty biotechnology company dedicated to advancing a new
standard of respiratory critical care, today announced that it has submitted
an investigational new drug (IND) application to the U.S. Food and Drug
Administration (FDA) to initiate its AEROSURF^® phase 2 clinical program. The
FDA has confirmed receipt of the IND and has indicated that, unless otherwise
notified during its review, the Company may initiate the phase 2 clinical
program after a 30-day period. Discovery Labs anticipates patient enrollment
could begin in the fourth quarter of 2013. The Company will host a conference
call this morning at 10:00 AM ET to discuss the AEROSURF program. Conference
call details are below.
"The filing of our AEROSURF IND with the FDA represents an important milestone
for our Company and a first step towards a potentially transformational
medical advancement for the neonatology community and the infants they care
for," said John G. Cooper, Chief Executive Officer at Discovery Labs.
AEROSURF is a novel investigational drug-device combination product being
developed to deliver Discovery Labs' KL4 surfactant in aerosolized form to
premature infants with respiratory distress syndrome (RDS). 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.
"The AEROSURF program is leveraging important advancements in our novel
technology platform," said Russell Clayton, DO, Senior Vice President,
Research and Development, at Discovery Labs. "Our synthetic KL[4] surfactant
technology was recently validated with the FDA approval of SURFAXIN^® for the
prevention of RDS in infants at high risk for RDS. We are now combining our
KL4 surfactant with our proprietary drug delivery technologies to potentially
deliver aerosolized KL[4] surfactant to patients with respiratory disease,
with an initial focus on the unmet medical needs in premature infants with
RDS."
Conference Call and Webcast Details
Discovery Labs will hold a conference call and webcast today at 10:00 AM EDT
to discuss the foregoing. A live webcast of the conference call, including a
slide presentation, is available at http://bit.ly/17KTf5r and
www.discoverylabs.com. An archive of the webcast will be available on
Discovery Labs' Investor Relations web site.
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