Discovery Labs Receives $1.0 million under an SBIR Grant in Continuing Support of the Development of Aerosolized KL4 Surfactant to Address Radiation-Induced Lung Injury

WARRINGTON, Pa., July 30, 2015 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO) today announced that it has received the second $1.0M tranche under a previously awarded Phase II Small Business Innovation Research (SBIR) grant valued at up to $3.0 million to support continued development of the company's aerosolized KL4 surfactant as a potential medical countermeasure to mitigate acute and chronic/late-phase radiation-induced lung injury.  Discovery Labs was awarded an initial $1.0 million under this grant in October 2014 and over the next year may be awarded up to an additional $1.0 million following completion of certain research activities.

The primary objectives of the first phase of the research conducted under the award included establishing appropriate conditions for both the acute and long-term studies of aerosolized KL4 surfactant in an animal model, and initiating studies to confirm that aerosolized KL4 surfactant would reduce acute lung injury associated with radiation exposure.  Preliminary results of that research indicate that early treatment with aerosolized KL4 surfactant was able to preserve oxygenation and reduce lung inflammation. 

The research to be performed under this next phase of the grant includes the potential confirmation that early intervention with KL4 surfactant may prevent the effects of radiation exposure, which may lead to pulmonary fibrosis months or years following exposure.  All of the research under the SBIR grant is being conducted in conjunction with Melpo Christofidou-Solomidou, Ph.D., a leading expert in novel antioxidant approaches to acute and chronic lung diseases with the University of Pennsylvania's Perelman School of Medicine.

Discovery Labs believes that its proprietary KL4 surfactant may have utility in a variety of radiation-induced lung injuries, including damage to the lungs occurring as a result of a radiological accident or terrorism threat agent, but also to lung damage occurring as a result of radiation therapy as treatment 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.

The U.S. Government's 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.  Research reported in this press release was supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) under award number R44AI102308.  The content is solely the responsibility of Discovery Labs and does not necessarily represent the official views of the NIH.

About Discovery Labs 
Discovery Laboratories, Inc. is a specialty biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases.  Pulmonary surfactants are produced naturally in the lung and are essential for normal respiratory function and survival.  If surfactant deficiency or degradation occurs, the air sacs in the lungs can collapse, resulting in severe respiratory diseases and disorders.  Discovery Labs' technology platform includes a novel synthetic peptide-containing (KL4) surfactant that is structurally similar to naturally occurring pulmonary surfactant and proprietary drug delivery technologies being developed to enable efficient delivery of aerosolized KL4 surfactant.  Discovery Labs believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of aerosolized surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies.

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 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.

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