Monopar Announces Completion of Phase 2b Enrollment and Commencement of Phase 3 Enrollment in its VOICE Trial for Severe Oral Mucositis
October 05 2022 - 8:00AM
Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage
biopharmaceutical company focused on developing proprietary
therapeutics designed to extend life or improve the quality of life
for cancer patients, today announced an update on its
actively enrolling Validive Phase 2b/3 VOICE clinical trial for the
prevention of severe oral mucositis (SOM) in patients undergoing
chemoradiotherapy (CRT) for oropharyngeal cancer. This is an
indication for which there is currently no FDA-approved
preventative or treatment.
Monopar announced it has enrolled greater than 130 patients, has
completed enrollment for the Phase 2b portion of the trial, has
activated a total of 68 sites, has recently expanded the trial to
include sites in Germany and Poland, and has commenced enrollment
for the Phase 3 portion of the trial. The blinded interim analysis
of clinical data from the Phase 2b patient cohort of the trial, to
be performed by an independent data monitoring board, will be used
to guide the Company as to whether or not to continue enrolling the
Phase 3 portion of the trial. This analysis should be complete with
interim results announced during Q1 2023.
“In planning for success for a potential positive go/no-go
outcome from the upcoming Q1 2023 interim analysis, we have been
actively enrolling patients and adding clinical sites to the VOICE
trial and expect to continue doing so,” said Chandler Robinson, MD,
Monopar’s Chief Executive Officer. “Expanding to include additional
sites outside of the U.S. will dramatically increase the number of
patients available for enrollment in the study.”
About Monopar Therapeutics Inc.
Monopar Therapeutics is a clinical-stage biopharmaceutical
company 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: that the VOICE trial’s interim
analysis is currently anticipated to be reached in the first
quarter of 2023; that Monopar will continue to enroll patients and
add sites to the VOICE trial; and that Monopar will activate
additional clinical sites outside of the U.S. The forward-looking
statements involve risks and uncertainties including, but not
limited to: not successfully recruiting additional patients and
initiating additional clinical trial sites for the VOICE clinical
trial within expected timeframes, if at all; that the VOICE
clinical trial may not reach interim analysis by the first quarter
of 2023, if at all; the Company’s inability to raise sufficient
funds or engage a partner to complete the Phase 3 portion of the
VOICE clinical trial; 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
Follow Monopar on social media for
updates:Twitter: @MonoparTx LinkedIn: Monopar
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