Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) (“Diffusion” or the
“Company”), a biopharmaceutical company developing novel therapies
to enhance the body’s ability to deliver oxygen to areas where it
is needed most, today announced that after collaboration with the
United States Food and Drug Administration (“FDA”) on the design of
their Phase 2 clinical trial entitled “Open-Label, Dose-Escalation,
Phase 2 Safety and Efficacy Study of TSC in Newly Diagnosed
Glioblastoma (“GBM”) Patients when Administered with Standard of
Care (“SOC”)”. The trial will be designated Study 200-208. The
Company expects to initiate the trial by the end of 2022 and
anticipates dosing the first patient in the trial in the first
quarter of 2023.
GBM is an aggressive, deadly, and treatment-resistant type of
malignant brain tumor, affecting approximately 13,000 newly
diagnosed patients each year in the United States. Few treatment
options are available for patients with GBM, and none have extended
life expectancy beyond a few months. In fact, according to the
National Brain Tumor Society, the five-year survival rate for GBM
is only 6.8 percent with an average survival time of eight
months.
“Effective treatment of GBM remains a significant unmet need and
we believe in the potential for TSC to enhance the effectiveness of
standard of care therapy for GBM,” said Robert Cobuzzi, Jr., Ph.D.,
President and Chief Executive Officer of Diffusion. “These tumors
are known to be hypoxic, which reduces the effectiveness of radio-,
chemo-, and immunotherapeutic approaches and promotes tumor cell
metastases. We have previously received Orphan Drug designation
from the FDA for treatment of GBM with TSC in conjunction with
radiotherapy. With the results of the TCOM and Altitude Trials, we
now have better data on TSC dosing compared to the previous GBM
trials, and we have used these data to design a unique trial that
not only will allow us to evaluate the effects of TSC on key
clinical outcomes such as survival, but the use of PET imaging also
will enable us to obtain data on the direct effects of TSC on GBM
tumor oxygenation well before clinical outcome data is typically
available in clinical trials involving GBM patients.”
The study will include a dose-escalation phase, enrolling
patients in a 3+3+3 design, to evaluate the safety, tolerability,
pharmacokinetics, and pharmacodynamics of TSC at doses of 1.5
mg/kg, 2.0 mg/kg and 2.5 mg/kg administered in combination with
concomitant standard of care radiotherapy (“RT”) plus temozolomide.
An additional 17 subjects will be treated at the highest tolerable
dose identified in the dose escalation phase. The primary objective
of the study is to evaluate the safety and tolerability of TSC for
the treatment of patients with newly diagnosed GBM when
administered with SOC. Secondary objectives of the study are to
evaluate progression-free survival at six months by magnetic
resonance imaging, assessment using Response Assessment in
Neuro-Oncology criteria, and to evaluate overall survival at 12
months.
Study 200-208 will vary in a variety of ways from the GBM trials
conducted by Diffusion in the past, including three particularly
notable differentiators:
- The 1.5 mg/kg to 2.5 mg/kg doses of TSC to be administered in
the study will be 6-10-fold higher than the 0.25 mg/kg dose used in
Diffusion’s prior GBM trials.
- TSC will be administered five days each week approximately
30-60 minutes prior to radiotherapy, as compared to the three days
per week regimen in Diffusion’s prior GBM trials.
- The study trial will incorporate PET scans to directly evaluate
the oxygen enhancing effects of TSC on tumor hypoxia using one of
two radiotracers, 18F-FMISO or 18F-FAZA, with initial data readouts
expected to be available within one year of the study’s
initiation.
"For patients with hypoxic tumor microenvironments such as
glioblastoma, radiation can be less effective. Diffusion
Pharmaceutical's proposed phase 2 trial of Trans Sodium Crocetinate
(TSC) for glioblastoma patients may help to overcome the relative
resistance of the hypoxic tumor to ionizing radiation. Improvements
in the clinical outcomes for high-grade glioma patients are
critically needed,” said Dr. Jason Sheehan, MD, PhD, Neurosurgeon
at University of Virginia School of Medicine.
“With Glioblastoma Awareness Day on July 20th serving as a stark
reminder of the continued unmet need for this disease, our team is
incredibly motivated to work with our clinical investigators to get
this uniquely designed trial started to explore the potential of
TSC to improve outcomes for patients suffering from this
devastating diagnosis,” noted Chris Galloway, MD, Chief Medical
Officer of Diffusion.
About Diffusion Pharmaceuticals Inc.Diffusion
Pharmaceuticals Inc. is a biopharmaceutical company developing
novel therapies to enhance the body’s ability to deliver oxygen to
areas where it is needed most. Diffusion’s lead product candidate,
TSC, is being investigated to enhance the diffusion of oxygen to
tissues with low oxygen levels, also known as hypoxia, a serious
complication of many of medicine’s most intractable and
difficult-to-treat conditions, including hypoxic solid tumors. For
more information, please visit us
at www.diffusionpharma.com.
Forward-Looking StatementsThis press release
includes express and implied forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, including: the potential therapeutic value of TSC in GBM
and other indications; the anticipated design of Study 200-208;
anticipated timelines for the initiation, completion, and
announcement of data from the Company’s ongoing and planned
clinical trials; and the Company’s near-term strategic priorities
with respect to the development of TSC and otherwise. The Company
may, in some cases, use terms such as “believes,” “estimates,”
“anticipates,” “expects,” “plans,” “intends,” “may,” “could,”
“might,” “will,” “should,” “approximately,” or other words that
convey uncertainty of future events or outcomes to identify these
forward-looking statements. Although the Company believes that it
has a reasonable basis for each forward-looking statement contained
herein, forward-looking statements by their nature involve risks
and uncertainties, known and unknown, many of which are beyond the
Company’s control and, as a result, the Company’s actual results
could differ materially from those expressed or implied in any
forward-looking statement. Particular risks and uncertainties
include, among other things, those related to: the novelty of the
design of Study 200-208; the relevance of trends observed in the
Company’s Oxygenation Trials in normal healthy volunteers to the
study to any indication, including GBM and other hypoxic solid
tumors; the therapeutic value of TSC; the optimal doses and dosing
regimens of TSC in connection with the potential treatment of GBM
or any other particular disease or indication; the Company’s
ability to fund, design, initiate, enroll, execute, and complete
Study 200-208; the clinical and regulatory relevance of the results
that may be observed in the PET hypoxia imaging component of Study
200-208; the likelihood and timing of regulatory approval of TSC,
if any, for the treatment of GBM or any other indication, or the
nature of any feedback the Company may receive from the U.S. Food
and Drug Administration or other regulatory bodies; the impact of
global supply chain disruptions on the Company’s drug product
manufacturing capabilities, clinical development program, and
associated timelines; the Company’s ability to protect and expand
its intellectual property portfolio; general economic, political,
business, industry, and market conditions, including the ongoing
COVID-19 pandemic, inflationary pressures, and geopolitical
conflicts; and the other factors discussed under the heading “Risk
Factors” in the Company’s filings most recent Annual Report on Form
10-K and other filings with the U.S. Securities and Exchange
Commission. Any forward-looking statements in this press release
speak only as of the date hereof (or such earlier date as may be
identified) and, except as required by applicable law, rule, or
regulation, the Company undertakes no obligation to update any such
statements after the date hereof.
ContactsInvestors:Tiberend
Strategic Advisors, Inc. Daniel Kontoh-Boateng/Jonathan
Nugentdboateng@tiberend.comjnugent@tiberend.com
Media:Kate
BarretteRooneyPartnersKbarrette@rooneypartners.com
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