Exhibit
99.1
Monopar Reaches Target Number of Clinical Sites
in Phase 2b
Portion of 2b/3 Validive®
VOICE
Trial
WILMETTE, Ill., August 5, 2021 – Monopar
Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage
biopharmaceutical company primarily focused on developing
proprietary therapeutics designed to extend life or improve the
quality of life for cancer patients, today announced it has
successfully reached its target of 20 activated clinical trial
sites in the Phase 2b portion of the VOICE
trial.
Validive® is a small,
easy-to-use mucobuccal tablet that can be self-administered in the
patient’s home setting. The VOICE study evaluates
Validive® for the
prevention of severe oral mucositis (SOM) in oropharyngeal cancer
patients. SOM results from the chemoradiation used to treat
oropharyngeal cancer (OPC). There is no FDA-approved preventative
or treatment option for the estimated >40,000 OPC patients in
the US annually who are at-risk of developing SOM.
“We are very pleased to reach this clinical milestone and to
achieve clinical site enrollment rates that have exceeded our base
case projections to date,” said Octavio Costa, MD,
Monopar’s Chief Medical Officer. “We are proud of our
clinical team’s efforts and grateful for the support from
participating patients and staff at our clinical sites, who are
joining us in our focus to prevent this painful debilitating
condition that results in patients losing the ability to drink
and/or eat.”
“In planning for success and the Phase 3 portion of the VOICE
trial, and as a result of strong interest from sites in joining the
trial, we are going to expand the number of sites beyond the
original 20 targeted,” said Chandler Robinson, MD,
Monopar’s Chief Executive Officer. “Because of interest
outside the US, we are also looking at activating sites in
additional countries, potentially later this
year.”
Monopar anticipates reaching the interim analysis of the Phase 2b/3
Validive® VOICE trial in
the first half of 2022. Further information about the trial is
available at
www.ClinicalTrials.gov under study
identifier NCT
04648020.
About Severe Oral Mucositis
Severe oral mucositis (SOM) is a painful and debilitating
inflammation and ulceration of the mucous membranes lining the oral
cavity and oropharynx in response to insults such as chemoradiation
treatment (CRT). SOM is the most frequent major side effect
experienced by oropharyngeal cancer patients, experienced by a
majority of those undergoing CRT. SOM impacts both quality of life
and clinical outcomes for these patients. SOM prevents patients
from drinking and/or eating, and can lead to severe weight loss,
opiate usage, and the use of feeding tubes as well as intravenous
supplementation to keep alive. Patients who develop SOM can become
hospitalized, and symptoms can force patients to prematurely stop
cancer treatment, reducing treatment efficacy and long-term
survival.
About Monopar Therapeutics Inc.
Monopar Therapeutics
is a clinical-stage biopharmaceutical company primarily focused on
developing proprietary therapeutics designed to extend life or
improve the quality of life for cancer
patients. Monopar's pipeline consists
of Validive for the prevention of
chemoradiotherapy-induced severe oral mucositis in oropharyngeal
cancer patients; camsirubicin for the treatment of
advanced soft tissue sarcoma; a late-stage preclinical antibody,
MNPR-101, for advanced cancers and severe COVID-19; and an
early-stage camsirubicin analog, MNPR-202, for various cancers. For
more information, visit: www.monopartx.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that
are not historical facts are "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. The words “may,” “will,”
“could,” “would,” “should,”
“expect,” “plan,” “anticipate,”
“intend,” “believe,”
“estimate,” “predict,”
“project,” “potential,”
“continue,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Examples of these forward-looking
statements include statements concerning: Monopar’s plan to
expand the number of sites beyond the original 20 targeted,
including the Company’s plan to activate sites in additional
countries, potentially later this year; and that Monopar
anticipates reaching the interim analysis of the Phase 2b/3
Validive VOICE trial in the first half of 2022. The forward-looking statements involve
risks and uncertainties including, but not limited to:
Monopar’s inability to enroll the VOICE trial as planned;
Monopar not reaching the interim
analysis of the Phase 2b/3 Validive VOICE trial within the anticipated timeframe, if at
all; the Company’s inability to complete the VOICE trial;
that Validive may not prove to be clinically efficacious;
and the
significant general risks and uncertainties surrounding the
research, development, regulatory approval, and commercialization
of therapeutics. Actual results may differ materially from those expressed
or implied by such forward-looking statements. Risks are described
more fully in Monopar's filings with the Securities and Exchange
Commission. All forward-looking statements contained in this press
release speak only as of the date on which they were
made. Monopar undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made. Any forward-looking
statements contained in this press release represent
Monopar’s views only as of the date hereof and should
not be relied upon as representing its views as of any subsequent
date.
CONTACT:
Monopar Therapeutics Inc.
Investor Relations
Kim R. Tsuchimoto
Chief Financial Officer
kimtsu@monopartx.com
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