Monopar Presents Data Showing Tumor Reduction Benefit of Camsirubicin from Ongoing Phase 1b at the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting
01 Noviembre 2023 - 5:00AM
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, will present data from its ongoing Phase 1b
open-label, dose-escalating clinical trial of camsirubicin in
patients with advanced soft tissue sarcoma (ASTS) later today at
the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting,
which is bringing together the world’s leading sarcoma specialists.
Monopar’s poster presentation can be found at the following link:
https://www.monopartx.com/pipeline/Camsirubicin/mnpr-201-001-clinical-trial.
Clinical Trial Results To-Date
The Phase 1b clinical trial has enrolled 14 ASTS patients (9
female and 5 male) to-date ranging in age from 26 to 81 years
(median = 52.5 years) across five dose cohorts. The trial is
currently ongoing and is in the fifth dose level cohort (650
mg/m2).
So far, 9 out of the 14 patients have had stable disease (SD, as
defined by RECIST 1.1 criteria) after camsirubicin treatment. All
patients in the fourth and fifth cohorts achieved stable disease,
including the three most recently treated patients, each of whom
also experienced an ~20% tumor size reduction at last study scan.
One of these patients had unresectable cancer at study entry, but
after the tumor size reduction, the patient became eligible for
resection and underwent successful surgical removal of their cancer
with clear margins.
No dose-limiting toxicity, as defined in the protocol, has been
observed to-date. A medically complex patient in the 650 mg/m2 dose
cohort has an ongoing left ventricular ejection fraction (LVEF)
decrease that is being monitored. This patient has a BMI of 42.5,
one kidney, hypertension, a long standing heart murmur, and a
maternal history of heart failure. No toxicities have occurred
requiring expansion of a dose cohort, and the maximum tolerated
dose (MTD) has not been reached.
Camsirubicin Background
ASTS is a deadly cancer with inadequate treatment options.
Doxorubicin is currently the first-line standard of care treatment
for most types of ASTS, and the average life expectancy from time
of diagnosis for these patients is only about 12 to 15 months.
Because of the risk of irreversible heart damage, patients
discontinue doxorubicin treatment after just 6 to 8 cycles.
Camsirubicin was designed to retain the anti-cancer activity while
avoiding the irreversible heart damage that is seen with
doxorubicin. The value-driving hypothesis for camsirubicin is
straightforward: modifying doxorubicin to reduce cardiac damage
could enable both higher and longer dosing, resulting in better
efficacy and patient outcomes.
About Monopar Therapeutics Inc.Monopar
Therapeutics is a clinical-stage biopharmaceutical company focused
on developing innovative treatments for cancer patients. Monopar's
pipeline consists of camsirubicin (Phase 1b) for the treatment of
advanced soft tissue sarcoma; MNPR-101, a late-stage preclinical
antibody for radiopharmaceutical use in advanced cancers; and
MNPR-202, an early-stage camsirubicin analog 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 camsirubicin has been designed
to retain the anti-cancer activity while avoiding the irreversible
heart damage that is seen with doxorubicin; that the hypothesis for
camsirubicin is straightforward: modifying doxorubicin in order to
reduce cardiac damage could enable higher and longer dosing,
resulting in better efficacy and patient outcomes. The
forward-looking statements involve risks and uncertainties
including, but not limited to: the camsirubicin Phase 1b trial not
proving safety and efficacy at higher doses; not successfully
recruiting additional patients and initiating additional clinical
trial sites for the camsirubicin Phase 1b clinical trial within
expected timeframes, if at all; the Company’s inability to raise
sufficient funds or engage a partner to continue the camsirubicin
clinical program beyond the Phase 1b 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 Therapeutics
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