NEW
YORK, Dec. 27, 2023
/PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a
patient-focused biopharmaceutical company, announced today that it
has received approval from the University of
Miami to enroll patients for its first in human clinical
trial of HT-001.
This First-in-Human (FIH) Phase 2a clinical
trial of HT-001 for the treatment of skin toxicities associated
with Epidermal Growth Factor Receptor Inhibitors (EGFRi). This
clinical trial is a randomized, placebo-controlled, parallel Phase
2a dose-ranging study to investigate the efficacy, safety, and
tolerability of topical HT-001 for the treatment of skin toxicities
associated with EGFRi. More information can be found
at clinicaltrials.gov.
"We are very pleased to have received approval
for our FIH clinical trial," said Hoth Therapeutics Chief Executive
Officer, Robb Knie. "We are hopeful
that this trial will demonstrate successful delivery of our lead
therapeutic candidate HT-001. Coupled with approval at Washington University of St. Louis and MD Anderson Cancer Center,
University of Miami will be our third
site approved to host our trial and bring hope to cancer patients
suffering from skin toxicities associated with EGFRi
treatments. I look forward to updating our investors and patients
on this ongoing trial in the first quarter of 2024."
About Hoth Therapeutics, Inc.
Hoth Therapeutics is a clinical-stage
biopharmaceutical company dedicated to developing innovative,
impactful, and ground-breaking treatments with a goal to improve
patient quality of life. We are a catalyst in early-stage
pharmaceutical research and development, elevating drugs from the
bench to pre-clinical and clinical testing. Utilizing a
patient-centric approach, we collaborate and partner with a team of
scientists, clinicians, and key opinion leaders to seek out and
investigate therapeutics that hold immense potential to create
breakthroughs and diversify treatment options. To learn more,
please visit https://ir.hoththerapeutics.com/.
Forward-Looking Statement
This press release includes forward-looking
statements based upon Hoth's current expectations which may
constitute forward-looking statements for the purposes of the safe
harbor provisions under the Private Securities Litigation Reform
Act of 1995 and other federal securities laws, and are subject to
substantial risks, uncertainties, and assumptions. These statements
concern Hoth's business strategies; the timing of regulatory
submissions; the ability to obtain and maintain regulatory approval
of existing product candidates and any other product candidates we
may develop, and the labeling under any approval we may obtain; the
timing and costs of clinical trials, the timing and costs of other
expenses; market acceptance of our products; the ultimate impact of
the current Coronavirus pandemic, or any other health epidemic, on
our business, our clinical trials, our research programs,
healthcare systems or the global economy as a whole; our
intellectual property; our reliance on third party organizations;
our competitive position; our industry environment; our anticipated
financial and operating results, including anticipated sources of
revenues; our assumptions regarding the size of the available
market, benefits of our products, product pricing, timing of
product launches; management's expectation with respect to future
acquisitions; statements regarding our goals, intentions, plans and
expectations, including the introduction of new products and
markets; and our cash needs and financing plans. There are a number
of factors that could cause actual events to differ materially from
those indicated by such forward-looking statements. You should not
place reliance on these forward-looking statements, which include
words such as "could," "believe," "anticipate," "intend,"
"estimate," "expect," "may," "continue," "predict," "potential,"
"project" or similar terms, variations of such terms or the
negative of those terms. Although the Company believes that the
expectations reflected in the forward-looking statements are
reasonable, the Company cannot guarantee such outcomes. Hoth may
not realize its expectations, and its beliefs may not prove
correct. Actual results may differ materially from those indicated
by these forward-looking statements as a result of various
important factors, including, without limitation, market conditions
and the factors described in the section entitled "Risk Factors" in
Hoth's most recent Annual Report on Form 10-K and Hoth's other
filings made with the U. S. Securities and Exchange Commission. All
such statements speak only as of the date made. Consequently,
forward-looking statements should be regarded solely as Hoth's
current plans, estimates, and beliefs. Investors should not place
undue reliance on forward-looking statements. Hoth cannot guarantee
future results, events, levels of activity, performance, or
achievements. Hoth does not undertake and specifically declines any
obligation to update, republish, or revise any forward-looking
statements to reflect new information, future events or
circumstances or to reflect the occurrences of unanticipated
events, except as may be required by applicable law.
Investor Contact:
LR Advisors LLC
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791
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SOURCE Hoth Therapeutics, Inc.