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’s needed most, today
announced the presentation of a poster detailing an innovative
on-ambulance Phase 2 study with the Company’s lead drug trans
sodium crocetinate (TSC) for the treatment of acute stroke. The
poster was presented on February 7th at the American Heart
Association’s International Stroke Conference, held February 6-8 in
Honolulu.
The poster is titled “PreHospital Administration
of Stroke Therapy with Trans Sodium Crocetinate (PHAST-TSC) Trial”
with authors:
- Andrew M. Southerland, MD, MSc, University of Virginia Health
System;
- Nerses Sanossian, MD, University of Southern California;
- Timothy L. McMurray, PhD, University of Virginia Health
System;
- John L. Gainer, PhD, Diffusion Pharmaceuticals, Inc.;
- Anna Grace, MA, RN, CCRP, Diffusion Pharmaceuticals, Inc.;
- Amy C. Fansler, MPH, University of Virginia Health System;
- Guy M. Chisolm, III, PhD, Chair, Diffusion Scientific Advisory
Board;
- Karen C. Johnston, MD, M.Sc., University of Virginia Health
System;
- Jeffrey L. Saver, MD, University of California, Los Angeles
Health System.
The poster presents the design of the
randomized, double-blind, placebo-controlled PHAST-TSC
(Pre-Hospital Ambulance Stroke Trial-TSC) trial, which will enroll
80 suspected stroke patients in the active arm (0.25 mg/kg of TSC)
and 80 suspected stroke patients in the control arm (normal saline)
at participating stroke centers/EMS in Los Angeles County and
central Virginia. The primary trial endpoint is the extent of
disability at 90 days using the utility-weighted modified Rankin
Scale (UW-mRS). Safety endpoints include serious adverse
events and all-cause mortality.
TSC holds promise as a neuroprotective agent in
acute stroke as it is expected to off-set the decrease that occurs
in brain oxygen caused by stroke from either a clot or a
bleed. As part of the PHAST-TSC trial protocol, all patients
must be treated within two hours of their first stroke symptoms.
Administering TSC while the patient is on the ambulance will start
this reoxygenation process as soon as possible after the stroke
occurs.
An investigational new drug application has been
approved by the U.S. Food and Drug Administration and
investigational review board approval is pending at participating
sites. EMS training and community education for exception
from informed consent is about to begin in Los Angeles County and
central Virginia. Anticipated enrollment of the first patient
is expected this spring, subject to receipt by Diffusion of the
necessary funding for the trial.
“We are very pleased to highlight the details of
this innovative trial design at such a prestigious medical
conference,” said David Kalergis, Chairman and CEO of Diffusion.
“We expect this poster will be helpful as we work to gain awareness
for Diffusion and for TSC, both in the US and internationally.”
In addition, the poster includes references to
preclinical data suggesting that TSC has benefit for both ischemic
and hemorrhagic stroke, as well as promise in glioblastoma
multiforme (GBM) and peripheral artery disease.
Additional information about the
PHAST-TSC trial
The Phase 2 randomized, double-blind, placebo
controlled PHAST-TSC trial will enroll 160 suspected stroke
patients age 40-85, with 128 coming from up to 20 hospitals in the
greater Los Angeles area and 32 coming from three central Virginia
hospitals. Half the patients will be randomized to receive
TSC and half to placebo. The primary endpoint is mortality or
patient neurological disability as measured by the modified Rankin
scale administered 90 days after stroke occurrence. Because the
follow-up period in the trial is only 90 days post-treatment,
complete data collection is expected within 21 months of first
patient enrollment, offering a timely and cost-effective assessment
of a potential breakthrough therapeutic in one of healthcare’s most
significant unmet medical needs.
The PHAST-TSC Diffusion-sponsored clinical trial
is a cooperative effort by Diffusion and its Chief Science Officer
and inventor of the TSC molecule John L. Gainer, PhD and
Diffusion’s Scientific Advisory Board Chair Guy Chisolm, PhD, in
close cooperation with the Director of UCLA’s Stroke Center Jeffrey
Saver, MD and the Chair of UVA’s Department of Neurology Karen
Johnston, MD. Co-principal investigators for the study are
Andrew Southerland, MD (UVA) and Nerses Sanossian, MD (University
of Southern California). Other important participants include
approximately 150 emergency medical transport groups based in Los
Angeles and Central Virginia. Diffusion will be seeking additional
financing or a partnering arrangement to fund the trial.
More information about Diffusion’s clinical
programs, including both its INTACT Phase 3 trial in inoperable GBM
brain cancer and its PHAST-TSC acute stroke program, are available
on Diffusion’s Website at www.diffusionpharma.com.
About the International Stroke
Conference
The International Stroke Conference is the
world’s premier meeting dedicated to the science and treatment of
cerebrovascular disease. It is organized by the American Heart
Association.
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’s 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 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.
In 2018 the Company began enrolling patients in
its Phase 3 INTACT program, using TSC to target inoperable GBM
brain cancer. Its on-ambulance PHAST-TSC acute stroke protocol was
granted FDA clearance to proceed in September 2018.
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 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: the
difficulty of developing pharmaceutical products, obtaining
regulatory and other approvals and achieving market acceptance;
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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