Discovery Labs : Aerosolized KL-4 Surfactant Selected for Evaluation in Phase 2a Cystic Fibrosis Clinical Trial

September 3, 2008 - First Clinical Trial Evaluating Aerosolized KL-4 Surfactant in Patients With Cystic Fibrosis - Discovery Laboratories, Inc. (NasdaqGM:DSCO) announces that its proprietary, aerosolized KL-4 surfactant has been selected for a Phase 2a clinical trial in patients with Cystic Fibrosis (CF). The trial is being conducted as an investigator-initiated study under the direction of Dr. Scott H. Donaldson at The University of North Carolina and is funded primarily through a grant provided by the Cystic Fibrosis Foundation.
The trial is designed as a double-blind, randomized study to evaluate whether Discovery Labs' aerosolized KL-4 surfactant is safe and well tolerated in patients with mild to moderate CF lung disease. In addition, the short-term effectiveness of aerosolized KL-4 will be assessed. UNC's Investigational New Drug (IND) Application for this study was submitted to the United States Food and Drug Administration and went into effect in May 2008. Patient enrollment is expected to begin this fall.

CF is characterized by a genetic mutation that produces thick, viscous mucus that is difficult to clear from the airways of the lung and typically leads to life-threatening respiratory infections. Preclinical and exploratory clinical studies suggest that therapeutic surfactants may improve lung function by loosening mucus and making it easier to clear... [PDF] Discovery Labs' Press Release -

Discovery Labs : Approvable Letter from FDA for Surfaxin for RDS

May 2, 2008 - Discovery Laboratories, Inc. (Nasdaq:DSCO) today announced that it has received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. This official notification sets forth the remaining conditions that must be satisfied to gain U.S. marketing approval for Surfaxin... [PDF] Discovery Labs' Press Release -

Discovery Labs and Chrysalis Technologies : about Collaboration for Future Development of Aerosolized Drug Device Products

April 2, 2008 - Discovery Laboratories, Inc. (NasdaqGM:DSCO ) and Chrysalis Technologies (a division of Philip Morris USA, Inc.) have been collaborating to develop combination drug device products that unite Discovery Labs' precision-engineered synthetic surfactant with Chrysalis' novel capillary aerosolization technology to address respiratory diseases. To date, the collaboration has focused on developing a prototype device for use in Discovery Labs' upcoming Phase 2 clinical trials for Aerosurf, aerosolized Surfactant Replacement Therapy (SRT) for premature infants. Under the modified collaboration, Discovery Labs will assume full responsibility, effective July 1, 2008, to further develop the capillary aerosolization technology into devices for potential clinical and commercial application... [PDF] Discovery Labs' Press Release -

Discovery Labs, Aerosurf Improves Lung Function and Reduces Inflammation in a Model of Respiratory Distress Syndrome

December 3, 2007 — ...Aerosurf is an aerosolized formulation of Discovery Lab’s novel KL4 surfactant technology that is delivered non-invasively via novel aerosol generating technology and employs nasal continuous positive airway pressure (nCPAP). Aerosurf, like Discovery’s lead product Surfaxin®, is a precisionengineered synthetic, peptide-containing surfactant which is designed to closely mimic the essential attributes of human lung surfactant.... Discovery Labs' PDF -

Discovery Laboratories, Surfaxin Process Validation Batches

Oct. 1, 2007 , 2007 - Discovery Laboratories, Inc. (NasdaqGM:DSCO) today announces that its new Surfaxin(r) (lucinactant) process validation batches have demonstrated acceptable stability at six months under Discovery Labs' comprehensive stability testing protocol. This six-month stability data will be included, along with other data and information, in a formal response to the U.S. Food and Drug Administrations' (FDA) April 2006 Approvable Letter for Surfaxin for the prevention of Respiratory Distress Syndrome (RDS) in premature infants... Discovery Laboratories' Press Release [PDF] -