Diffusion Pharmaceuticals Announces FDA Accelerated Review of TSC Clinical Development Plan to Treat COVID-19 Patients with A...
May 05 2020 - 8:00AM
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 the U.S. Food
and Drug Administration (FDA) will accelerate its review of the
Company’s clinical development plan using trans sodium crocetinate
(TSC) in COVID-19 patients displaying severe respiratory symptoms
and low oxygen levels. Development of Acute Respiratory Distress
Syndrome (ARDS) is common in patients hospitalized with COVID-19
due to lack of sufficient oxygen to vital organs as a consequence
of impedance in the lungs. Diffusion believes that TSC’s novel
oxygen-enhancing mechanism of action could provide an important new
treatment option for this life-threatening condition.
Under federal regulations, the FDA had up to 60
days from the Company’s April 24, 2020 submission to respond, but
the FDA has announced its intention to significantly shorten review
times for select COVID-19 submissions under its Coronavirus
Treatment Acceleration Program (CTAP). Clinical trial preparations
at multiple potential sites are continuing as the Company awaits
the FDA’s expedited response.
Diffusion’s COVID-19 program is a cooperative
research effort with the University of Virginia Health System (UVA)
and the Integrated Translational Research Institute of Virginia
(iTHRIV). To aid in timely trial enrollment, Diffusion is in
discussions with institutions located in areas of severe COVID-19
incidence, both in the U.S. and in Eastern Europe. Similar to the
FDA CTAP, health authorities in certain Eastern European countries
have implemented emergency policies to compress regulatory review
cycles from months to just days. These policies could expedite
partnering possibilities with one or more Eastern European national
institutes currently treating hundreds of COVID-19 patients daily,
with almost immediate study start up and shortened time to
data.
“This news of accelerated FDA review of the
proposed clinical development plan for our lead compound TSC in a
COVID-19 ARDS program is most welcome,” said David Kalergis, chief
executive officer of Diffusion. “We continue to work with hospital
and regulatory authorities in the U.S., and now also in Eastern
Europe, to forge the fastest possible pathway to approval for TSC
in the treatment of COVID-19 patients.”
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 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 TSC as a
treatment for Acute Respiratory Distress Syndrome (ARDS) from
COVID-19, 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: the
uncertainty as to whether the protocol described above, which is a
pre-IND submission, will be ultimately acceptable to the FDA for an
IND submission or that the FDA will not require significant changes
that might take significant time to implement, if at all, or that
any such required changes will be financially feasible; moreover,
if this or a revised protocol is acceptable to the FDA for an IND
submission, there can be no assurance as to when the FDA might
provide such guidance or when the program might be able to
commence, if at all; the uncertainty that as of yet the FDA has no
approved a trial evaluating TSC for the treatment of ARDS, or if
approved, such a trial possibly entailing significant additional
time, effort and expense, particularly in light of the difficulty
of doing business during the COVID-19 pandemic; 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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