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, announced
today that it has been awarded a patent for the use of its
breakthrough drug, trans sodium crocetinate (TSC), in conjunction
with Tissue Plasminogen Activator (tPA) for the treatment of
stroke. Currently, tPA – a thrombolytic used to break down blood
clots in patients suffering from ischemic stroke – is the only
FDA-approved therapeutic stroke treatment. Worldwide, stroke is the
second leading cause of death and is responsible for an estimated
6.2 million deaths per year.
The granting of Diffusion’s patent follows the
recent news that the Company received FDA approval to enroll
patients in an ambulance-based Phase 2 clinical trial testing TSC
for the treatment of both ischemic and hemorrhagic stroke.
The use of TSC represents a potential
breakthrough in the treatment of stroke, which afflicts nearly
800,000 Americans each year. Diffusion’s FDA-approved Phase 2
clinical trial will focus on the concept of early intervention –
allowing patients suffering from either ischemic or hemorrhagic
stroke to receive TSC on the ambulance or in the emergency
department immediately upon onset of symptoms. Patients can then,
separately, receive tPA in-hospital if they are found to be
suffering from ischemic stroke. If the clinical trial is
successful, there is the potential to establish a new standard of
care, with a combination drug therapy which could generate over $1
billion annually.
“The granting of exclusive rights for the use of
TSC in conjunction with tPA for the treatment of stroke is a
significant development for Diffusion,” said Thomas E.
Byrne, General Counsel of Diffusion. “We’re excited about
the opportunity this patent affords, as it gives Diffusion
exclusive rights over the use of these two drugs together, a
combination which may make a real difference for patients suffering
from stroke.”
With the notification by the United States
Patent Office of the issuance of U.S. Patent 10,130,689, Diffusion
now has patent protection over the use of TSC in conjunction with
tPA in the United States, Japan, and Korea, with pending
applications in Europe, Canada, China, Israel, and India.
“Nearly two million brain cells die each minute
during a stroke, and TSC is a significant innovation in how
patients receive care, given that it will potentially be the first
and only front-line treatment,” said David
Kalergis, Chairman and CEO of Diffusion. “Our company is
committed to fighting life-threatening medical conditions, and
there’s no doubt that stroke is a life-threatening and
life-altering condition for families throughout our country and
around the world. This patent is an extension of that
commitment, as our research indicates that using TSC in conjunction
with tPA – which remains the only FDA approved therapeutic for
stroke – improves outcomes for patients.
“As we continue to explore national and
international strategic partnerships, we believe this patent will
provide additional opportunities for conversation while
strengthening the company’s position within the industry,”
said Bill Hornung, Chief Financial Officer of
Diffusion. “We look forward to the legal protection this
patent affords as we continue our efforts to grow Diffusion and
pursue the possibilities for our lead drug, TSC.”
In order to enhance value to its investors and
stockholders, Diffusion has a robust intellectual property program
aimed at protecting its existing and potentially expanded assets.
The Company’s patents relating to TSC include claims to
compositions of matter, treatment of cancer in combination with
radiation and/or chemotherapy, and treatment of a full range of
non-cancer hypoxic conditions, including stroke, heart attack,
pulmonary embolism, respiratory conditions and neurodegenerative
diseases. Fourteen US patents have been issued; forty-six have
issued abroad. Patents cover the major markets (The United States,
European Union, and Japan), with key patent life until 2026, plus
expected extensions until 2031.
Seven-year Orphan exclusivity provides
additional protection, and formulation patents provide protection
for the TSC oral drug product until 2031, with possible
extensions.
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 Crocinate
(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, GBM
brain cancer, pancreatic cancer, and brain metastases. In each of
these diseases, hypoxia – when essential tissue in your body is
deprived of oxygen – 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. It’s on-ambulance Phase 2 acute stroke protocol was
granted FDA clearance to proceed in September, 2018.
Additional pre-clinical 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.
In addition, RES-529, the Company’s
PI3K/AKT/mTOR pathway inhibitor that dissociates the mTORC1 and
mTORC2 complexes, is in the preclinical testing phase 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 company's actual results to be materially different
than those expressed in or implied by such forward-looking
statements. Particular uncertainties and risks include: general
business and economic conditions; the company's need for and
ability to obtain additional financing or partnering arrangement;
the difficulty of developing pharmaceutical products, obtaining
regulatory and other approvals and achieving market acceptance; 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.
Contact:Rob
Corradirob@penpublicaffairs.com410-212-5483
Diffusion Pharmaceuticals (NASDAQ:DFFN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Diffusion Pharmaceuticals (NASDAQ:DFFN)
Historical Stock Chart
From Sep 2023 to Sep 2024