WARRINGTON, Pa., Nov. 3, 2016 /PRNewswire/ -- Windtree
Therapeutics, Inc. (Nasdaq:WINT), a biotechnology company focused
on developing aerosolized KL4 surfactant therapies for respiratory
diseases, announced today that recently presented preclinical data
at the 62nd Radiation Research Society Annual Meeting
suggest that KL4 surfactant could potentially be an effective
medical countermeasure to mitigate acute and chronic/late-phase
radiation-induced lung injury (pneumonopathy) due to exposure from
a nuclear accident or act of terrorism. The Company believes that,
as a possible additional application, KL4 surfactant may also
mitigate radiation pneumonopathy associated with cancer radiation
therapy.
"While we remain primarily focused on the rigorous and timely
execution of the AEROSURF® phase 2 clinical development program for
premature infants with respiratory distress syndrome (RDS), a Phase
I SBIR grant of $600,000 from the
National Institute of Allergy and Infectious Diseases (NIAID) of
the National Institutes of Health (NIH) provided us the opportunity
to explore the use of KL4 surfactant to mitigate damage to lungs
after radiation exposure," commented Craig
Fraser, President and Chief Executive Officer. "We are very
encouraged by the results of this early preclinical work and are
grateful for the support provided by the NIH. Based on the results
of this initial study, Windtree was awarded $3 million in additional funding from the NIAID
to support the further exploration of aerosolized KL4 surfactant as
a potential medical countermeasure for radiation exposure."
In this initial study, KL4 surfactant was administered via an
intranasal route into the lungs of C57/BL6 mice 24-hours following
exposure to a single fraction of high-dose (13.5 Gy)
thoracic-targeted X-ray irradiation (XRT). Mice were evaluated for
evidence of reduced blood oxygenation and lung inflammation between
two to four weeks post-XRT, and lung fibrosis, chronic pneumonitis,
oxidative stress and local and systemic inflammation at 18-weeks
post-XRT, by assessing lung function, and analyzing bronchoalveolar
fluid (BALF), serum and lung tissue.
The data from this study indicate that KL4 surfactant treatment
significantly preserved blood oxygenation in irradiated mice two
and four weeks post-XRT suggesting reduced acute lung injury,
coupled with significantly reduced lung inflammation in irradiated
mice three and 18 weeks post-XRT. KL4 surfactant-treated
irradiated mice also showed a decrease in lung fibrosis and
pneumonitis at 18 weeks post-XRT, evidence of reduced
chronic/late-phase radiation-induced lung injury.
"Though an early study, these data are especially encouraging as
the U.S. Department of Health and Human Services has indicated that
there is an urgent and unmet need to develop medical
countermeasures to prevent radiation pneumonopathy that can be
efficiently administered within days, if not hours post-exposure.
These data combined with our promising work to deliver aerosolized
KL4 surfactant represent progress toward potentially providing an
effective and efficient means to counter exposure to potential
radiation lung damage under various circumstances, including
potentially as a result of cancer radiation therapy," said
Robert Segal, M.D., Senior Vice
President, Clinical Development & Academic Affairs, Windtree
Therapeutics, the study principle investigator, who conducted this
research in collaboration with Melpo Christofidou-Solomidou, PhD,
Research Professor of Medicine at the University of Pennsylvania.
Acute and chronic/late-phase radiation induced lung
injury
Exposure to ionizing radiation (IR) from an unpredictable
nuclear reactor accident, a nuclear attack, deliberate terrorist
actions, including the detonation of a radiological dispersal
device (RDD), and, represents a significant public health concern.
Radiological and nuclear threats are complex, as the radiation
source, duration and extent of exposure all contribute to the
nature and effects of IR exposure. The lung is particularly
susceptible to injury from IR-exposure from external radiation
sources, as well as from inhaled radioactive particles from nuclear
radioactive fallout as an example. Radiation pneumonopathy can
manifest with acute radiation pneumonitis (ARS) and/or delayed
effects of acute radiation exposure (DEARE), which may lead to
progressive, often fatal, pulmonary fibrosis many months or years
later, with a median survival of 2 to 4 years. This is also seen
with pulmonary radiation exposure as a result of radiation therapy
for certain types of cancer.
This preclinical study of KL4 surfactant as a potential medical
countermeasure to mitigate acute and chronic/late-phase
radiation-induced lung injury was supported, in part, by a
$0.6 million Phase I Small Business
Innovation Research (SBIR) grant from the National Institute of
Allergy and Infectious Diseases (NIAID) of the National Institutes
of Health (NIH) under award number R43AI102308. The follow-on
Phase II SBIR $3.0 M grant supporting
ongoing research of aerosolized KL4 surfactant as a radioprotectant
is being funded under award number R44AI102308. The
content of this press release is solely the responsibility of
Windtree Therapeutics, Inc. and does not necessarily represent the
official views of the National Institutes of Health or the
University of Pennsylvania.
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 29 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 AEROSURF, which may involve
time-consuming and expensive clinical trials that may be subject to
potentially significant delays or regulatory holds, or fail; risks
related to the development of aerosol delivery systems (ADS) and
related components; risks related to the manufacture by contract
manufacturers or suppliers of drug products, drug substances, 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.