Diffusion Pharmaceuticals Doses First Participants in Altitude Trial
November 22 2021 - 7:02AM
Diffusion Pharmaceuticals Inc. (NASDAQ:
DFFN) (“Diffusion” or the “Company”), a biopharmaceutical
company developing novel therapies that enhance the body’s ability
to deliver oxygen to areas where it is needed most, today announced
it has dosed the first participants in its Altitude Trial. The
trial will evaluate the Company’s lead product candidate, trans
sodium crocetinate (“TSC”), in normal healthy volunteers subjected
to incremental levels of physical exertion while exposed to hypoxic
and hypobaric conditions, or “simulated altitude.”
“It’s been exciting working with our
internationally recognized partners to get this trial started, and
we look forward to continuing to leverage their expertise in
hypoxia research and their unique extreme exposure simulation
facilities as the study proceeds,” said Chris Galloway, M.D., Chief
Medical Officer of Diffusion. “We designed the Altitude Trial not
only to evaluate how TSC can enhance oxygen uptake in a simulated
hypoxic environment while under stress, but also to evaluate how
effectively oxygen is delivered and ultimately utilized under these
conditions. We believe the Altitude Trial’s results can inform
additional clinical uses of TSC to enhance oxygenation across a
multitude of diseases complicated by hypoxia.”
The Altitude Trial is a double-blind,
randomized, placebo-controlled crossover study designed to evaluate
the effects of TSC on maximal oxygen consumption, or VO2, and
partial pressure of blood oxygen, or PaO2, in normal healthy
volunteers subjected to incremental levels of physical exertion
while exposed to “simulated altitude.” Diffusion intends to enroll
30 healthy volunteers and give each volunteer a single dose of TSC
at one of three different doses. This study will evaluate the
effectiveness of TSC in enhancing oxygen delivery to the blood and
tissues during exercise under hypoxic conditions. The Company
anticipates completing the study in late December 2021 or early
January 2022, subject to the pace of participant enrollment, and
reporting topline results within two months of study
completion.
The Altitude Trial is the second in a series of
three, short-term studies Diffusion is conducting intended to
provide the Company with additional information regarding TSC’s
mechanism of action and dose-response characteristics. The results
of the Altitude Trial, together with the results of the Company’s
TCOM Trial (announced in June 2021) and its ILD-DLCO Trial,
expected to commence in December 2021, will be used to further
inform the design of clinical trials aimed at supporting the
commercialization of TSC as a treatment for conditions complicated
by hypoxia.
While the Company intends to continue developing
data to support TSC’s broad potential uses, it recently announced
that its near-term focus will be the design and execution of a
clinical program to support the use of intravenously administered
TSC as a treatment for hypoxic solid tumors, and that it intends to
obtain input from the U.S. Food and Drug Administration on the
program’s design in early 2022.
About Diffusion Pharmaceuticals
Inc.
Diffusion Pharmaceuticals Inc. is a
biopharmaceutical company developing novel therapies that enhance
the body’s ability to deliver oxygen to areas where it is needed
most. Diffusion’s lead product candidate, TSC, is being developed
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. In November 2021, based on the
preclinical and clinical data accumulated to date and the
significant unmet medical need, Diffusion announced that its
near-term focus will be the design and execution of a clinical
program to support the use of intravenously administered TSC as a
treatment for hypoxic solid tumors. For more information, please
visit us at www.diffusionpharma.com.
Forward-Looking Statements
This press release includes express and implied
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including
regarding the Company’s near-term strategic priorities, anticipated
timelines for the initiation, completion, and announcement of data
from the Company’s Oxygenation Trials and Hypoxic Solid Tumor
Program, the relevance and significance of any such data, and the
potential therapeutic value of TSC. 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 risk and uncertainties
include, among other things, those related to: the Company’s
ability to design, initiate, enroll, execute, and complete its
planned studies evaluating TSC; the likelihood and timing of
regulatory approval of TSC, if any, for the treatment of solid
tumors complicated by hypoxia 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
supply chain and other supplier issues on the Company’s clinical
development program and associated timelines; the Company’s ability
to protect and expand its intellectual property portfolio; the
Company’s ability to maintain compliance with the continued listing
standards of Nasdaq; general economic, political, business,
industry, and market conditions, including the ongoing COVID-19
pandemic; 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.
Contacts:Tiberend Strategic
Advisors, Inc. Maureen McEnroe, CFA/ Lisa
Shermmcenroe@tiberend.com/ lsher@tiberend.com
Media Contact:Kate BarretteRooneyPartners
Kbarrette@rooneypartners.com
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