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 it has entered
into an agreement with the Romanian National Institute of
Infectious Diseases (NIID) to begin a clinical trial program to
test Diffusion’s lead drug trans sodium crocetinate (TSC) for the
treatment of hospitalized COVID-19 patients presenting with lowered
blood oxygen levels, a condition known as hypoxemia. Noted
infectious disease researcher Prof. Adrian Streinu-Cercel, M.D.,
Ph.D., General Manager of the NIID, will serve as Principal
Investigator.
Conduct of this clinical trial in Romania will
be facilitated by ARENSIA Exploratory Medicine GmbH, a
Germany-based contract research organization with dedicated
state-of-the-art clinical research facilities located throughout
Eastern Europe, including within the NIID.
Patients with COVID-19 and other severe
respiratory tract infections often present with hypoxemia.
Diffusion and its affiliated researchers believe the
oxygen-enhancing mechanism of action of TSC could benefit COVID-19
patients by mitigating the multiple organ failure that often
results from hypoxemia associated with Acute Respiratory Distress
Syndrome (ARDS), a leading cause of death in COVID-19 patients.
The NIID trial is planned to be conducted in two
phases, with a possible third to follow. The first trial, which is
fully funded by existing Diffusion resources, is a Phase 1
open-label, pharmacokinetic/pharmacodynamic, ascending-dose safety
lead-in trial in 24 hospitalized hypoxemic COVID-19 patients. In
addition to collecting safety and tolerability data, study
endpoints will include arterial blood gas analysis and pulse
oximetry measurement. This trial is expected to be completed in the
third quarter of 2020. These data are intended to provide
proof-of-concept for the use of TSC in enhancing oxygenation of
hypoxemic patients with severe respiratory infections, like
COVID-19. Assuming positive results, Diffusion intends to promptly
commence a follow-on trial, also fully funded by existing Diffusion
resources, in approximately 100 patients at an expanded number of
study sites in Europe. This follow-on trial will be a
placebo-controlled, double-blinded, safety and efficacy study of
TSC in hypoxemic COVID-19 patients. Depending upon the results, a
third phase, designed with a view to regulatory approval in Europe,
may then be conducted.
Commencement of the NIID program is expected to
be facilitated by a special Romanian regulatory authority
initiative for COVID-19 clinical trials that reduces regulatory
approval times from 60 days down to seven days from the time of
program submission, which is targeted for the end of May 2020. NIID
is the largest provider of treatment for COVID-19 patients in
Romania. NIID sources report that about 500 patients with COVID-19
are currently hospitalized in its facility, with about 50 in
intensive care.
As previously reported, Diffusion also is
preparing for U.S-based clinical trials of TSC for the treatment of
hypoxemia in patients with severe respiratory infections, including
COVID-19, which will be conducted largely in parallel to NIID
trials. This arm of the Company’s respiratory distress-related
hypoxemia program is being pursued in partnership with the
University of Virginia and other leading U.S.-based research
centers. A pre-IND submission is currently under review by the U.S.
Food and Drug Administration (FDA) with a response expected before
the end of this month.
“We at the National Institute of Infectious
Diseases are expediting our collaboration with Diffusion
Pharmaceuticals to test TSC’s novel oxygenation-enhancing mechanism
of action to treat ARDS in patients with COVID-19,” said Prof.
Streinu-Cercel. “Given the shortened response times for regulatory
approvals and the immediate availability of patients, we expect
timely enrollment and prompt completion of the first phase of this
study.”
“We welcome the addition of Prof. Streinu-Cercel
and the NIID to the growing ranks of researchers seeking to
investigate TSC for use in COVID-19 patients,” said David Kalergis,
chief executive officer of Diffusion. “We believe that the
combination of high-quality research facilities, streamlined
regulatory policies and a large patient pool will expedite the
assessment of TSC’s effect in treating hypoxemia related to severe
respiratory infections, including COVID-19. We are also hopeful to
soon get the go-ahead from the U.S. FDA to submit an IND to allow
the commencement of clinical development in the United States.”
TSC is in clinical development by the Company
for the treatment of other conditions related to low-oxygen levels
including the treatment of acute stroke and glioblastoma multiforme
(GBM) brain cancer. Preclinical data indicate TSC increases oxygen
availability and provides a functional benefit in animal models of
acute lung injury and hemorrhagic shock. Clinical data from 150
patients receiving TSC for other indications demonstrate that the
drug has an acceptable human safety profile in both healthy and
critically ill 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 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, lack of
available oxygen presents 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.
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 both U.S. and
European-based institutions in its research program to develop TSC
as a treatment for the hypoxemia associated with COVID-19,
specifically targeting enhanced blood gas oxygenation.
Preclinical data supports the potential for TSC
as a treatment for other conditions where low oxygen availability
plays a major role, such as myocardial infarction, peripheral
artery disease, and neurodegenerative conditions such as
Alzheimer’s and Parkinson’s disease. In addition to the
development of TSC, 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 for the
Romanian trial, will be ultimately acceptable to the Romanian
healthcare regulatory authorities or that such regulators 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 Romanian regulators, there can be no assurance as
to when they might provide such guidance or when the program might
be able to commence, if at all; the uncertainty that as of
yet the Romanian regulators have not 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; the uncertainty as to whether the FDA will
ever approve an IND submission for commencement of a trial in the
U.S.; 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
protocol that has been submitted to the FDA on a pre-IND basis or a
revised protocol is acceptable to the FDA, there can be no
assurance as to when the FDA might provide such guidance or when
the program in the U.S. might be able to commence, if at all;
the uncertainty that as of yet the FDA has not 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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