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.
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SOURCE Windtree Therapeutics, Inc.