Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a
cutting-edge biotechnology company developing new treatments for
life-threatening medical conditions by improving the body’s ability
to bring oxygen to the areas where it is needed most, announces
that the first patient has been enrolled in its Phase 2
on-ambulance study evaluating trans sodium crocetinate (TSC) for
the treatment of stroke. The 160-patient trial, named
PHAST-TSC (Pre-Hospital Administration of Stroke Therapy-TSC), will
involve 23 hospitals, working closely with approximately 150
emergency medical transport groups across Central Virginia and
urban, suburban and rural areas in Los Angeles County. Results from
the trial may be available in just under two years.
The first patient was treated by ambulance-based
Emergency Medical Technicians in co-ordination with researchers at
the University of Virginia Medical Center (UVA).
Diffusion expects enrollment at the University
of Los Angeles (UCLA) to begin later this quarter, where about 20
hospital sites will be participating. The PHAST-TSC trial Study
Chair is Jeffrey Saver, M.D., Professor of Clinical Neurology and
Director of the Stroke Unit at the David Geffen School of Medicine
at UCLA. Co-Principal Investigators are Andrew Southerland, M.D.
(UVA) and Nerses Sanossian, M.D. (University of Southern
California).
“We are delighted the PHAST-TSC study has begun
and are optimistic enrollment will pick up rapidly given the large
number of participating institutions and the prevalence of stroke,”
said David Kalergis, chairman and chief executive officer of
Diffusion. “The study design calls either for TSC or placebo to be
administered by paramedics while the stroke victim is still in the
ambulance, regardless of whether the stroke is ischemic or
hemorrhagic. Our preparations were time-consuming due to the
extensive training and coordination of first responders, and our
work to ensure adequate supply of TSC was delivered to the
ambulances.
“Because we believe TSC can reduce cell death
and improve outcomes by increasing the amount of oxygen directed to
affected tissue, utility is expected in both major types of stroke.
Our clinical research has shown that TSC has an excellent patient
safety profiles, which contrasts with the leading thrombolytic,
tissue plasminogen activator, or tPA, which may only be used with
ischemic stroke in inpatient settings. With stroke patients,
time is of the essence to obtain treatment. Because it can be given
in the ambulance, TSC may provide an important improvement in the
field. In addition, our preclinical work showed that TSC in
combination with tPA may extend the timeframe wherein tPA may be
administered, thus expanding the potential utility of TSC in this
indication,” Mr. Kalergis added.
About Stroke
Stroke is a disease that affects the arteries
leading to and within the brain. According to the American Stroke
Association, it is the No. 5 cause of death and a leading cause of
disability in the United States.
A stroke occurs when a blood vessel that carries
oxygen and nutrients to the brain is either blocked by a clot or
bursts (or ruptures). When that happens, part of the brain cannot
get the blood (and oxygen) it needs, so it and brain cells die.
Stroke can be caused either by a clot obstructing the flow of blood
to the brain (called an ischemic stroke) or by a blood vessel
rupturing and preventing blood flow to the brain (called a
hemorrhagic stroke). A TIA (transient ischemic attack), or "mini
stroke," is caused by a temporary clot.
About Diffusion Pharmaceuticals
Inc.
Diffusion Pharmaceuticals Inc. is an innovative
biotechnology company developing new treatments that improve the
body’s ability to bring oxygen to the areas where it is needed
most, offering new hope for the treatment of life-threatening
medical conditions.
Diffusion’s lead drug TSC was originally
developed in conjunction with the Office of Naval Research, which
was seeking a way to treat hemorrhagic shock caused by massive
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 stroke and
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 the target for TSC’s
novel mechanism.
Its on-ambulance PHAST-TSC acute stroke protocol
has begun patient enrollment. 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
brain cancer. Additional preclinical data supports the
potential use of TSC as a treatment for other conditions where
hypoxia plays a major role, such as myocardial infarction,
respiratory diseases such as COPD, 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, the anticipated timing of future clinical trials, 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 Diffusion’s actual results to be materially different
than those expressed in or implied by such forward-looking
statements. Particular uncertainties and risks include: the
difficulty of developing pharmaceutical products, obtaining
regulatory and other approvals and achieving market acceptance;
ability to enroll patients, general business and economic
conditions; 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)
220-0718dkalergis@diffusionpharma.com
LHA Investor RelationsKim Sutton Golodetz(212)
838-3777kgolodetz@lhai.com
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