Monopar to Present Results from Analysis of Oropharyngeal
Cancer Patients in Completed Phase 2 Validive® Trial at
MASCC/ISOO
WILMETTE, Ill. June
24, 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 that it will present its
oropharyngeal cancer (OPC) patient population analysis of the Phase
2 Validive® (clonidine HCl
MBT) trial for the prevention of chemoradiotherapy-induced severe
oral mucositis in head and neck cancer at the Multinational
Association of Supportive Care in Cancer and International Society
of Oral Oncology (MASCC/ISOO) 2021 annual meeting. This analysis
provided the rationale for the design of Monopar’s Phase 2b/3
VOICE trial, which is open and accruing oropharyngeal cancer
patients in the US.
“We are excited to share the
data from our analysis at this pre-eminent multidisciplinary
conference dedicated to supportive care in cancer and for the
opportunity to continue working towards providing a treatment for
this debilitating condition,” said Andrew Mazar, PhD, Chief
Scientific Officer of Monopar.
Session Title: Mucositis - New
Dimensions in Research and Clinical Practice, Oral Proffered Paper
2
Presentation Title: Subgroup Analysis of
Head and Neck Cancer Patients Treated with Clonidine Mucobuccal
Tablet in a Randomized, Double-Blind Phase 2 Trial (Study
BA2009-28-01) Supports Further Clinical Development in Patients
with Oropharyngeal Cancer
Author: Andrew Mazar, PhD, Chief
Scientific Officer of Monopar Therapeutics
Date
and Time: The Company’s presentation will be available
on demand for registered attendees starting Friday, June 25, 2021
at 8:00am EDT. For information on registration, visit: https://www.mascc.org/2021-registration
About Validive®
Validive
(clonidine mucobuccal tablet; clonidine MBT) is a novel mucobuccal
tablet (MBT) formulation. The mucobuccal tablet provides for
prolonged and enhanced local delivery of clonidine to the regions
of oral mucosal radiation damage in OPC patients. The tablet is
self-administered once daily in the patient’s home setting
with the patient placing it under the upper lip where it adheres to
the gums and dissolves over several hours, continuously releasing
clonidine into the saliva. Clonidine agonizes the alpha-2
adrenergic receptor on macrophages (white blood cells present in
the immune tissues of the oropharynx), decreasing the
macrophages’ expression of the destructive cytokines that are
released in response to radiotherapy. A completed double-blind,
randomized, placebo-controlled Phase 2 clinical trial of Validive
showed reduced incidence compared to placebo (absolute decrease of
26%, relative decrease of 40%) in OPC patients treated with
Validive 100 µg, a safety profile similar to placebo, and a
high rate of treatment compliance (over 90%).
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: the
Company’s excitement for the opportunity to continue working
towards providing a treatment for severe oral mucositis;
and the Phase 2 trial
supporting further clinical development in patients with
oropharyngeal cancer.
The forward-looking
statements involve risks and uncertainties including, but not
limited to: that the
Phase 2 trial analysis will not provide successful rationale
for the conduct and design of Monopar’s Phase 2b/3 VOICE
trial; that Monopar may not provide a treatment for severe oral
mucositis; that Validive’s Phase 2b/3 VOICE trial may not
yield similar results as the Phase 2 trial or successful clinical
results;that Monopar may not successfully recruit and complete the
Phase 2b/3 VOICE trial;the requirement for additional capital to
complete the Phase 3 portion of the VOICE trial and potentially a
second smaller confirmatory Phase 3 trial, if required by the
regulators and, if successful, to commercialize Validive; not being
able to ensure volumes of Validive® can be manufactured and scaled up
to meet potential demand; uncertainties about levels of demand if
and when a treatment is available for commercialization; 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.
CONTACTS:
Monopar Therapeutics
Inc.
Investor
Relations
Kim R. Tsuchimoto
Chief Financial
Officer
kimtsu@monopartx.com
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