Monopar Announces First Patient Dosed in its Phase 2b/3 VOICE Trial Evaluating Validive® for the Prevention of Chemoradiothe...
February 16 2021 - 7:30AM
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 dosed
the first patient in its Phase 2b/3 VOICE trial of Validive® for
the prevention of chemoradiotherapy-induced severe oral mucositis
in patients with oropharyngeal cancer (VOICE).
Validive’s mucoadhesive buccal tablet formulation
allows for prolonged and enhanced local delivery of drug to the
regions of mucosal radiation damage, and its easy application under
the upper lip allows for convenient once-daily self-administration
in the patient’s home setting.
“With this important milestone accomplished we are
excited to be one step closer to bringing Validive to the
approximately 40,000 OPC patients per year in the US that have no
effective options for preventing or treating their
chemoradiotherapy-induced SOM,” said Chandler Robinson, MD, Chief
Executive Officer of Monopar. “SOM is a painful and debilitating
severe adverse effect of chemoradiotherapy (CRT) treatment and can
have significant negative impacts on clinical outcomes as well as
quality of life in both the short and long term.”
“The number of newly diagnosed individuals with
oropharyngeal cancer is growing,” said Andrew Mazar, PhD, Chief
Scientific Officer of Monopar. “CRT is the standard of care for
OPC, but unfortunately 60-70% of OPC patients undergoing CRT will
develop severe oral mucositis in the course of their
treatment.”
The completed Validive Phase 2 trial showed that
administering a single, once daily 100µg Validive tablet resulted
in a 40% reduction in the incidence of SOM compared to placebo in
OPC patients undergoing CRT treatment. Up to approximately 260
patients will be enrolled in the current multi-center, randomized,
double-blind, placebo-controlled, adaptive design Phase 2b/3 VOICE
trial.
Further information about the Validive Phase 2b/3
VOICE trial is available at www.ClinicalTrials.gov under study
identifier NCT 04648020.
About ValidiveValidive (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 they release 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 Severe Oral MucositisSevere
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; and a late-stage preclinical antibody, MNPR-101,
for advanced cancers and severe COVID-19. For more information,
visit: www.monopartx.com.
Forward-Looking
StatementsStatements 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 continue to enroll its
Validive Phase 2b/3 VOICE clinical trial; 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 whether the incidence of OPC will continue to grow
and continue to be treated with CRT. 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; the VOICE trial not yielding statistically
significant results; if successful, 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
RelationsKim R. TsuchimotoChief Financial
Officerkimtsu@monopartx.com
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