Monopar Announces Initiation of its
Phase 2b/3 (VOICE) Trial to Evaluate Validive® for the
Prevention of Chemoradiotherapy-Induced Severe Oral Mucositis (SOM)
in Oropharyngeal Cancer (OPC)
There are currently no FDA-approved
drugs to prevent or treat chemoradiotherapy-induced
SOM
WILMETTE, Ill., December 8, 2020 – 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 its Phase 2b/3 clinical trial of
Validive® for the
prevention of chemoradiotherapy-induced severe
oral mucositis in
patients
with oropharyngeal
cancer
(VOICE) is active and recruiting
patients.
“We are
pleased to have multiple clinical sites activated,” said
Andrew Mazar, PhD, Chief Scientific Officer of Monopar, “and
are looking forward to dosing the first patients
shortly.”
“The commencement of our Phase 2b/3 VOICE trial is a
significant milestone for Monopar and, it represents a key step in
the development of a therapy that could benefit many OPC
patients,” said Chandler
Robinson, MD, Chief Executive Officer of Monopar. “This trial
builds on the foundation of the completed Phase 2, and is designed
to confirm Validive reduces the incidence of SOM in OPC patients
undergoing chemoradiotherapy.” The completed Phase 2 trial
showed the incidence of SOM in OPC patients receiving Validive 100
µg to be 40% lower compared to those receiving
placebo.
It is estimated there will be greater than 40,000 new OPC patients
in the U.S. alone in 2021, the majority of whom will be treated
with chemoradiation and run substantial risk of developing SOM.
Currently, there is no FDA approved preventive or treatment for SOM
in these patients, emphasizing the clear unmet medical need in this
patient population.
Up to
approximately 260 patients will be enrolled in this multi-center,
randomized, double-blind, placebo-controlled, Phase 2b/3 clinical
trial. The trial includes an interim analysis, which is anticipated
to be reached approximately twelve months after the first patient
is dosed.
Further information about the Validive Phase 2b/3 VOICE trial is
available at www.ClinicalTrials.gov
under study identifier
NCT
04648020.
About Validive
Validive
(clonidine mucobuccal tablet; clonidine MBT) is a novel mucobuccal
tablet (MBT) formulation of clonidine which provides for prolonged
and enhanced local delivery of clonidine to the regions of 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 the 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
destructive cytokines they tend to release in response to
radiotherapy. A completed double-blind, randomized,
placebo-controlled Phase 2 clinical trial of Validive showed
reduced incidence (absolute decrease of 26%, relative decrease of
40%) in OPC patients treated with
Validive 100 µg (a meaningful trend in the Phase 2, which the
Phase 2b/3 is designed to confirm with a larger trial in OPC for
potential statistical significance), a safety profile
similar to the placebo, and a high rate of treatment compliance
(over 90%).
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 insult 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; and a late-stage preclinical
antibody, MNPR-101, for advanced cancers and severe COVID-19. 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 whether Monopar will successfully
enroll its Validive Phase 2b/3 VOICE clinical trial, if at all;
whether Validive will benefit OPC patients in the VOICE trial;
whether the VOICE trial will yield results similar to the Phase 2
clinical trial in OPC patients and that are statistically
significant; and whether the VOICE trial will reach the
interim analysis approximately twelve months from the first patient
dosed, if at all. The forward-looking
statements involve risks and uncertainties for Monopar including,
but not limited to, the requirement for additional capital to
complete the VOICE trial beyond the interim analysis and for
potential commercialization; 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.
CONTACT:
Monopar Therapeutics Inc:
Investor Relations
Kim R. Tsuchimoto
Chief Financial Officer
kimtsu@monopartx.com
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