Diffusion Pharmaceuticals Evaluating TSC Against Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients
April 01 2020 - 7:00AM
Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN)
(“Diffusion” or “the Company”), a cutting-edge biotechnology
company developing new treatments for life-threatening medical
conditions by improving the body’s ability to deliver oxygen to the
areas where it is needed most, today announced that it has begun a
cooperative research effort with University of Virginia Health
(UVA) and the Integrated Translational Research Institute of
Virginia (iTHRIV), to evaluate the Company’s novel small molecule
Trans Sodium Crocetinate (TSC) in patients with Acute Respiratory
Distress Syndrome (ARDS) associated with COVID-19 infection. iTHRIV
is a National Institutes of Health (NIH)-funded Clinical and
Translational Awards (CTSA) program. Dr. Andrew Southerland,
Associate Professor of Neurology and Public Health Sciences at UVA,
will serve as lead Principal Investigator, working with
co-investigators in the UVA Division of Pulmonary & Critical
Care Medicine.
Patients with COVID-19 infections are at risk
for developing ARDS, which can lead to death from systemic
hypoxemia (general lack of oxygen to body tissue and vital organs).
Diffusion, and researchers affiliated with UVA and iTHRIV, believe
the oxygen-enhancing mechanism of action of TSC could benefit
COVID-19 patients by mitigating the multiple organ failure that
often accompanies systemic hypoxemia, and are, together, exploring
avenues to advance TSC’s development as quickly as possible for
this use.
TSC is currently under clinical development by
the Company for other enhanced-oxygen-related uses including the
treatment of acute stroke and glioblastoma multiforme (GBM) brain
cancer. Preclinical data indicate TSC increases oxygen availability
in animal models of acute lung injury, mitigating the negative
effects of systemic hypoxemia. Preclinical publications also
indicate TSC’s ability to mitigate systemic hypoxemia in other
animal models, including hemorrhagic shock. Clinical data from 150
patients receiving TSC for other indications demonstrate that the
drug has an acceptable safety profile in both healthy and
critically ill patients.
The Company and UVA/iTHRIV have together begun
discussions with the U.S. Food and Drug Administration (FDA) to
assess possible regulatory pathways for the evaluation of TSC in
ARDS-related COVID-19 patients.
“We are in desperate need of
novel therapies to help combat the morbidity and mortality
associated with COVID-19 infection,” said Dr. Southerland. “Given
our experience partnering with Diffusion Pharmaceuticals to study
TSC in clinical trials for other conditions, we believe there is
strong biological plausibility that the drug could help COVID-19
patients suffering from ARDS. Our robust infrastructure of research
and clinical expertise at UVA positions us well to help bring TSC
to COVID-19 trials as soon as possible to determine if it can help
patients.”
“TSC’s oxygen-enhancing mechanism may help
address the often-fatal multiple organ failure from ARDS in
COVID-19 patients,” said Diffusion’s CEO, David Kalergis, JD/MBA.
“In addition to UVA/iTHRIV, the Company has begun coordination with
researchers from other institutions who have asked to participate
in this new program. We have also begun discussions with the FDA.
We will issue public updates as warranted by this fast-moving
situation.”
About Diffusion Pharmaceuticals
Inc.
Diffusion Pharmaceuticals Inc. is an innovative
biotechnology company developing new treatments that improve the
body’s ability to deliver oxygen to the areas where it is needed
most, offering new hope for the treatment of life-threatening
medical conditions. Diffusion’s lead drug trans sodium crocetinate
(TSC) was originally developed in conjunction with the Office of
Naval Research, which was seeking a way to treat multiple organ
failure and its resulting mortality caused by the systemic
hypoxemia from blood loss on the battlefield. Evolutions in
research have led to Diffusion’s focus today: Fueling Life by
taking on some of medicine’s most intractable and
difficult-to-treat diseases, including multiple organ failure,
stroke and glioblastoma multiforme (GBM) brain cancer. In each of
these diseases, hypoxia – oxygen deprivation of essential tissue in
the body – has proved to be a significant obstacle for medical
providers and is the target for TSC’s novel mechanism.
In July 2019 the Company reported favorable
safety data in a 19-patient dose-escalation run-in study to its
Phase 3 INTACT program, using TSC to target inoperable GBM. Further
findings from the dose-escalation run-in study, released in
December 2019, also showed possible signals of enhanced survival
and patient performance. Diffusion’s in-ambulance PHAST-TSC trial
for acute stroke began enrolling patients last year. Given the
heightened responsibilities of the Company’s partnering emergency
medical services providers, enrollment in this trial is expected to
be minimal until the Covid-19 pandemic abates. The Company is also
currently partnering with the University of Virginia and iTHRIV in
a research program to develop its novel small molecule Trans Sodium
Crocetinate (TSC) as a treatment for Acute Respiratory Distress
Syndrome (ARDS) from COVID-19 infection, specifically targeting the
associated multiple organ failure.
Preclinical data supports the potential for TSC
as a treatment for other conditions where hypoxia plays a major
role, such as myocardial infarction, peripheral artery disease, and
neurodegenerative conditions such as Alzheimer’s and Parkinson’s
disease. In addition, RES-529, the Company’s PI3K/AKT/mTOR
pathway inhibitor that dissociates the mTORC1 and mTORC2 complexes,
is in preclinical testing for GBM.
Diffusion is headquartered in Charlottesville,
Virginia – a hub of advancement in the life science and
biopharmaceutical industries – and is led by CEO David Kalergis, a
30-year industry veteran and company co-founder.
Forward-Looking Statements
To the extent any statements made in this news
release deal with information that is not historical, these are
forward-looking statements under the Private Securities Litigation
Reform Act of 1995. Such statements include, but are not limited
to, statements about the company's plans, objectives, expectations
and intentions with respect to future operations and products, the
potential of the company's technology and product candidates, and
other statements that are not historical in nature, particularly
those that utilize terminology such as "would," "will," "plans,"
"possibility," "potential," "future," "expects," "anticipates,"
"believes," "intends," "continue," "expects," other words of
similar meaning, derivations of such words and the use of future
dates. Forward-looking statements by their nature address matters
that are, to different degrees, uncertain. Uncertainties and risks
may cause the Diffusion’s actual results to be materially different
than those expressed in or implied by such forward-looking
statements. Particular uncertainties and risks include: as of yet
the FDA not having approved a trial evaluating TSC for the
treatment of ARDS, or if approved, such a trial possibly entailing
significant additional time, effort and expense; Diffusion’s
ability to maintain its Nasdaq listing, market conditions, the
difficulty of developing pharmaceutical products, obtaining
regulatory and other approvals and achieving market acceptance;
general business and economic conditions; the sufficiency of the
company’s cash, the company's need for and ability to obtain
additional financing or partnering arrangements; and the various
risk factors (many of which are beyond Diffusion’s control) as
described under the heading “Risk Factors” in Diffusion’s filings
with the United States Securities and Exchange Commission. All
forward-looking statements in this news release speak only as of
the date of this news release and are based on management's current
beliefs and expectations. Diffusion undertakes no obligation to
update or revise any forward-looking statement, whether as a result
of new information, future events or otherwise.
Contacts:David Kalergis, CEODiffusion Pharmaceuticals Inc.(434)
825-1834dkalergis@diffusionpharma.comorLHA Investor RelationsKim
Sutton Golodetz(212) 838-3777kgolodetz@lhai.com
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