Windtree Awarded $1.0 million SBIR Grant in Continuing Support of the Development of Aerosolized KL4 Surfactant to Address Radiation-Induced Lung Injury

WARRINGTON, Pa., July 14, 2016 /PRNewswire/ -- Windtree Therapeutics, Inc. (Nasdaq: WINT), a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today announced that it has received the third $1.0 million tranche under a previously announced 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 radiation-induced lung injury.  Windtree was previously awarded $2.0 million under this Phase II grant, and a $0.6 million SBIR Phase I award.

Windtree believes that its proprietary KL4 surfactant may have utility in a variety of conditions involving acute lung injury, including radiation-induced lung injuries resulting from a radiological accident or terrorism threat agent, or occurring as a side effect of radiation therapy for a number of thoracic malignancies.  Studies have suggested that radiation-induced injury may occur in up to 15 percent of patients receiving radiation therapy for lung cancer.

The initial animal-model research conducted under this SBIR grant assessed whether aerosolized KL4 surfactant would reduce acute and long-term lung injury associated with radiation exposure. Preliminary results indicate that treatment with aerosolized KL4 surfactant preserved oxygenation and reduced lung inflammation when administered both early and later in the course of radiation-induced lung injury. 

The preclinical research to be performed under the third phase of the grant includes continued assessment of both early and delayed administration of aerosolized KL4 surfactant to mitigate the delayed effects of radiation-induced lung injury including the development of pulmonary fibrosis. Research under this SBIR grant is being conducted by Robert Segal, MD, Principle Investigator at Windtree and 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.

The U.S. Government's support and interest in Windtree's 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.  These 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 is being 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 Windtree and does not necessarily represent the official views of the NIH.

About Windtree Therapeutics
Windtree Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel surfactant therapies for respiratory diseases and other potential applications. Windtree's proprietary technology platform includes a synthetic, peptide-containing surfactant (KL4 surfactant) that is structurally similar to endogenous pulmonary surfactant and novel drug-delivery technologies being developed to enable noninvasive administration of aerosolized KL4 surfactant. Windtree is focused initially on improving the management of respiratory distress syndrome (RDS) in premature infants and believes that its proprietary technology may make it possible, over time, to develop a pipeline of KL4 surfactant product candidates to address a variety of respiratory diseases for which there are few or no approved therapies.

Windtree's lead product candidate is AEROSURF®, a novel, investigational drug/device product that combines the Company's proprietary KL4 surfactant and aerosolization technologies.  AEROSURF is being developed to potentially reduce or eliminate the need for endotracheal intubation and mechanical ventilation in the treatment of premature infants with respiratory distress syndrome (RDS).  Enrollment is ongoing in a  phase 2b clinical trial in up to 240 premature infants to study AEROSURF in premature infants 26 to 32-week gestational age receiving nasal continuous positive airway pressure (nCPAP) for RDS, compared to infants receiving nCPAP alone.  The phase 2b trial is a global trial with clinical sites in North America, Europe and Latin America.

For more information, please visit the Company's website at www.windtreetx.com.

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 certain risks and uncertainties that could cause actual results to differ materially from the statements made.  Examples of such risks and uncertainties include those risks related to Windtree's aerosolized KL4 surfactant development programs, including for AEROSURF and radiation induced lung injury, which may involve time-consuming and expensive pre-clinical studies and eventual clinical trials, which may be subject to potentially significant delays or regulatory holds, or fail; risks related to the manufacture by contract manufacturers or suppliers of drug products, drug substances, aerosol delivery systems (ADS) and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including those of the U.S. Food and Drug Administration or other regulatory authorities that may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of Windtree's products; and other risks and uncertainties described in Windtree's 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.

SOURCE Windtree Therapeutics, Inc.

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