Diffusion Pharmaceuticals Receives Notice of Intention to Grant a Patent Related to Use of TSC in Combination with tPA in Isc...
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 bring oxygen to the
areas where it is needed most, today announced receipt from the
European Patent Office of a Notice of Intention to Grant a patent
related to the use of the Company’s lead compound trans sodium
crocetinate (“TSC”) in combination with the leading thrombolytic,
tissue plasminogen activator (“tPA”), in the treatment of ischemic
stroke. The patent claim covers administration of TSC within three
or four hours of the onset of stroke symptoms in combination with
tPA administered within nine to 12 hours of the onset of stroke
The European Patent Office has also granted two additional
patents to Diffusion. Patent, No. EP1667954B1 entitled “Bipolar
Trans Carotenoid Salts and Their Uses” covers the use of bipolar
trans-carotenoids, including TSC, to treat acute lung injury,
congestive heart failure, and pretreatment or treatment during or
after surgery. Patent No. EP 1487774B1, also entitled “Bipolar
Trans Carotenoid Salts and Their Uses,” relates to methods of
synthesizing bipolar trans carotenoid salts, including TSC. Similar
patents were previously issued in the U.S.
“We are building an important portfolio of intellectual property
on a global scale and are pleased with our continued progress to
protect TSC in multiple indications,” said David Kalergis, Chief
Executive Officer of Diffusion Pharmaceuticals. “As we prepare to
begin our Phase 2 on-ambulance trial for the treatment of stroke
this summer, we are heartened to receive additional protection in
Europe for our proprietary compound in combination with tPA.
“tPA is used to break down blood clots in patients suffering
from ischemic stroke and is the only FDA-approved stroke treatment.
While tPA has shown efficacy in ischemic stroke, it may not be used
in hemorrhagic stroke and precious time may be lost before the
determination is made as to which type of stroke a patient is
experiencing. TSC may provide an important solution as our
preclinical work has shown that TSC in combination with tPA may
extend the timeframe wherein tPA may be administered.
“More than 40 patents related to TSC have either been allowed or
issued in various geographies, including the U.S. and the EU, the
world’s two largest markets for pharmaceutical products, which
collectively account for approximately 80% of the world’s
pharmaceutical market,” Mr. Kalergis added.
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
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
In January 2018 the Company began enrolling patients in the
lead-in phase to its Phase 3 INTACT program, using TSC to target
inoperable GBM brain cancer. In September 2018 its on-ambulance
PHAST-TSC acute stroke protocol was granted FDA clearance to
proceed. 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
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
Contacts:David Kalergis, CEODiffusion Pharmaceuticals Inc.(434)
email@example.comLHA Investor RelationsKim
Sutton Golodetz(212) firstname.lastname@example.org
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