WARRINGTON, Pa., Oct. 17, 2013 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: 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 DetailsDiscovery 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. For "listen-only" participants and those who wish to take part in the question and answer portion of the call, the dial-in numbers are (877) 215-0093 (U.S.) or (706) 679-3237 (international). The passcode for the call is 86481667. The replay number is (855) 859-2056 or (404) 537-3406 using the same conference call passcode listed above. A replay will also be available at www.discoverylabs.com. About RDS and the Neonatologist's Dilemma RDS is a condition in which premature infants are born with a lack of natural lung surfactant and are unable to absorb sufficient oxygen. Premature infants born prior to 37 weeks gestation have not fully developed their own natural lung surfactant and therefore need treatment to sustain life. RDS is experienced in approximately half of the babies born between 26 and 32 weeks gestational age. The incidence of RDS approaches 100 percent in babies born less than 26 weeks gestational age. RDS can result in long-term respiratory problems and death.
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