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 is needed most, announces
increased survival in inoperable glioblastoma patients enrolled in
the 19-patient, open-label, dose-escalation lead-in portion of its
Phase 3 study with Trans Sodium Crocetinate (TSC) plus standard of
care (SOC). John Gainer, Ph.D., the Company’s chief
scientific officer, will present details of these findings at the
inaugural Glioblastoma Drug Development Summit being held in Boston
December 10-11, and sponsored by Hanson Wade. Dr. Gainer’s slide
presentation will be posted to the Company’s website at
www.diffusionpharma.com immediately prior to the conference.
In an earlier Phase 2 study testing TSC in newly
diagnosed glioblastoma multiforme (GBM) brain cancer patients, an
almost fourfold increase in 2-year survival was seen versus
historical controls in inoperable patients. The current Phase 3
INTACT (INvestigating Tsc
Against Cancerous
Tumors) study – an open-label, randomized,
controlled trial – is designed to examine this finding in a fully
powered safety and efficacy registration study, which, if
successful, could be the basis for US FDA approval.
In the INTACT trial, subjects are randomized at
baseline to SOC for first-line treatment of GBM plus TSC, or to SOC
alone. The SOC for GBM is temozolomide plus radiation therapy for 6
weeks, followed by 28 days of rest, then by 6 cycles of
post-radiation temozolomide treatment. In a modification to the
Phase 2 dosing regimen, patients in the INTACT trial will also
receive high-dose TSC during the post-radiation chemotherapy
phase.
A 19-patient, open-label, dose-escalation
lead-in portion to the INTACT trial was recently completed, sending
a positive safety signal across all patients receiving TSC.
In addition, six of the seven patients who received the high dose
TSC treatment are still alive, with a median survival at the
present time of 14.3 months. This is compared with 9.2 months for
the historical standard of patients with inoperable GBM. Since six
of the TSC-treated patients are still alive, median survival time
is actually increasing with the passage of time, suggesting the
INTACT trial may confirm or better the efficacy findings seen in
the Phase 2 study.
Patients’ abilities to perform their daily
activities as measured by Karnofsky performance scores increased
from the baseline following completion of high dose treatment with
TSC. Investigators have also reported instances of inoperable GBM
patients treated with the higher dose TSC regimen leaving hospice
or returning to work after treatment in the open-label portion of
the study.
“We are encouraged by these early findings
showing that patients enrolled in the lead-in portion of the INTACT
trial have experienced increased survival with our new protocol,”
said Dr. Gainer. “Although final conclusions will depend on
the completion of the randomized portion of the trial, we believe
that TSC helps to eradicate the low oxygen status of cancerous
tumors, and it appears this may also result in a survival benefit
compared with the current standard therapy.”
The Company previously announced it is seeking a
partner to continue development of TSC in the GBM indication and
has begun patient enrollment in its Phase 2 on-ambulance trial with
TSC for the treatment of stroke.
About Hanson Wade
Hanson Wade's goal is to accelerate progress
within organizations and across industries. Its primary method for
achieving this is by creating exclusive business conferences that
gather together the world's smartest thinkers and doers. The
inaugural Glioblastoma Drug Development Summit is designed with two
critical and ambitious objectives: to help overcome the major
biological challenges limiting effective Glioblastoma treatment;
and to evaluate novel therapies and innovative trial design to
prevent more tragic Phase 2 failures.
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 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.
Its on-ambulance PHAST-TSC acute stroke protocol
has begun patient enrollment. 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
brain cancer. 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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