Monopar Announces Result of Interim Analysis of Phase 2b/3 VOICE Trial Evaluating Validive for Severe Oral Mucositis
March 27 2023 - 4:00PM
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 completion of a
pre-specified interim analysis for its Validive Phase 2b/3 VOICE
trial for the prevention of severe oral mucositis (SOM) in patients
undergoing chemoradiotherapy (CRT) for oropharyngeal cancer (OPC).
This is an indication for which there is currently no FDA-approved
preventative or treatment.
The interim analysis included the first approximately 50% of the
total planned patients to be enrolled. It was conducted by an
independent Data Safety Monitoring Board (DSMB), which informed the
Company that the trial did not meet the pre-defined threshold for
efficacy of a 15% absolute difference in SOM prevention between
Validive and placebo. The DSMB also reported that there were no
safety concerns attributed to Validive. Based on not meeting the
pre-specified efficacy threshold, Monopar announced today that it
will be discontinuing the study along with the active development
of Validive.
“We are very grateful to the patients and investigators who
participated in the VOICE trial. The Phase 2b/3 VOICE trial was
intended to further evaluate a novel treatment for SOM following
the promising signals observed in a prior randomized,
double-blinded Phase 2 study with OPC patients. While we are
disappointed with the outcome of this study, we are now focused on
re-deploying the financial and human resources previously dedicated
to Validive in order to advance our Phase 1b camsirubicin clinical
trial and our MNPR-101 radiopharmaceutical program partnered with
NorthStar Medical Radioisotopes,” said Chandler Robinson, MD,
Monopar’s Chief Executive Officer.
Monopar also noted today that it has sufficient funds to support
its currently planned activities further beyond the first quarter
of 2024.
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 camsirubicin (Phase 1b) for the
treatment of advanced soft tissue sarcoma; a late-stage preclinical
antibody, MNPR-101, for radiopharmaceutical use in advanced
cancers; 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 Monopar remains focused on
re-deploying the financial and human resources previously dedicated
to Validive to advance its Phase 1b camsirubicin clinical trial and
its MNPR-101 radiopharmaceutical program; and that Monopar also
noted it has sufficient funds to support its currently planned
activities further beyond the first quarter of 2024. The
forward-looking statements involve risks and uncertainties
including, but not limited to: not successfully recruiting patients
in Monopar’s Phase 1b camsirubicin clinical trial within expected
timeframes, if at all; the Phase 1b camsirubicin clinical trial
does not provide safety or efficacy data; MNPR-101
radiopharmaceutical program partnered with NorthStar does not prove
safe or efficacious; Monopar does not have sufficient resources to
support its currently planned activities further beyond the first
quarter of 2024 and is unable to raise funds; 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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