– Annamycin continues to demonstrate no
evidence of cardiotoxicity to date, now in a total of 62 subjects
across three of the Company's Annamycin clinical trials
– Next generation anthracycline, Annamycin,
has demonstrated both safety and promising early activity across
multiple clinical studies with potential to be an effective
treatment across multiple oncology indications
HOUSTON, Sept. 18,
2023 /PRNewswire/ -- Moleculin Biotech, Inc.,
(Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage
pharmaceutical company with a growing pipeline, including Phase 2
clinical programs, for hard-to-treat tumors and viruses, today
announced it has received a new independent assessment for the
absence of cardiotoxicity in subjects treated with Annamycin. Data
from the following subjects were made available to an expert in
chemotherapy who is affiliated with a leading cancer research
institute in assessing cardiotoxicity. After review of this data,
the independent expert concluded that there was no evidence of
cardiotoxicity:
![Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.) Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)](https://mma.prnewswire.com/media/959635/Moleculin_Biotech_Inc_Logo.jpg)
- The first cohort of 3 subjects (190 mg/m2) of its
Phase 1B/2 clinical trial evaluating
Annamycin in combination with Cytarabine (also known as "Ara-C" and
for which the combination of Annamycin and Ara-C is referred to as
AnnAraC) for the treatment of subjects with AML as both first line
therapy and for subjects who are refractory to or relapsed after
induction therapy (MB106). clinicaltrialsregister.eu: EudraCT
2020-005493-10 or clinicaltrials.gov: NCT05319587;
- Cohort 4a (360 mg/m2) in the Phase 1B portion of the Company's ongoing U.S. Phase
1B/2 clinical trial evaluating
Annamycin for the treatment of soft tissue sarcoma lung metastases
(MB-107), comprised of 3 subjects. clinicaltrials.gov: NCT04887298;
and
- 14 subjects in the Phase 2 expansion Recommended Phase 2 Dose
(RP2D) (330 mg/m2) of the ongoing U.S. Phase
1B/2 MB-107 clinical trial.
- This brings the total reviewed by an independent expert to 62
subjects covering 4 separate clinical trials in the U.S. and in
Europe.
The data made available included left ventricular ejection
fraction (LVEF) as determined by echocardiograms, ECHO strain
imaging, and Troponin levels. "ECHO strain imaging" is a method in
echocardiography (medical ultrasound) for measuring regional or
global deformation (contraction or beating) of the myocardium
(heart muscle). By strain rate imaging, the simultaneous function
of different regions can be displayed and measured. Cardiac health
biomarkers such as blood Troponin levels are considered an
indicator of potential long-term heart damage.
"We continue to be encouraged by the potential of Annamycin,
especially with the reports from this expert covering 62 subjects.
This additional independent report of additional datasets provides
further validation in the absence of cardiotoxicity," commented
Walter Klemp, Chairman and Chief
Executive Officer of Moleculin. "Annamycin continues to establish
itself as a non-cardiotoxic anthracycline, even in subjects who
have received far more than the lifetime maximum cumulative
anthracycline exposure established by the FDA. In fact, 53 of the
62 subjects evaluated have been taken over the lifetime maximum of
450 mg/m2 and one of them as high as 3420
mg/m2. Our growing body of positive data for
Annamycin continues to bolster our confidence in our belief that
Annamycin is truly a 'next generation' anthracycline, especially in
light of the growing efficacy data that we have previously reported
in the treatment of STS lung mets and AML. We remain focused on
advancing our Annamycin development programs and ultimately,
addressing the medical unmet needs of people with difficult to
treat cancers and viruses."
Annamycin is the Company's next-generation anthracycline that
has been designed to be non-cardiotoxic (unlike currently
prescribed anthracyclines) and has been shown in animal models to
accumulate in the lungs at up to 30-fold the level of doxorubicin
(a commonly prescribed anthracycline), as well as demonstrating the
ability to avoid the multidrug resistance mechanisms that typically
limit the efficacy of doxorubicin and other currently prescribed
anthracyclines. Annamycin is currently in development for the
treatment of STS lung metastases (STS lung mets) as well as both
first line therapy and therapy for relapsed or refractory acute
myeloid leukemia (AML), and the Company believes the drug may have
the potential to treat additional indications.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical
company with a growing pipeline, including Phase 2 clinical
programs, for hard-to-treat tumors and viruses. The Company's lead
program, Annamycin is a next-generation anthracycline designed to
avoid multidrug resistance mechanisms with little to no
cardiotoxicity. Annamycin is currently in development for the
treatment of relapsed or refractory acute myeloid leukemia (AML)
and soft tissue sarcoma (STS) lung metastases.
Additionally, the Company is developing WP1066, an
Immune/Transcription Modulator capable of inhibiting p-STAT3 and
other oncogenic transcription factors while also stimulating a
natural immune response, targeting brain tumors, pancreatic and
other cancers, and WP1220, an analog to WP1066, for the topical
treatment of cutaneous T-cell lymphoma. Moleculin is also engaged
in the development of a portfolio of antimetabolites, including
WP1122 for the potential treatment of COVID-19 and other viruses,
as well as cancer indications including brain tumors, pancreatic
and other cancers.
For more information about the Company, please visit
www.moleculin.com and connect on Twitter, LinkedIn and
Facebook.
Forward-Looking Statements
Some of the statements in this release are forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995, which involve
risks and uncertainties. Although Moleculin believes that the
expectations reflected in such forward-looking statements are
reasonable as of the date made, expectations may prove to have been
materially different from the results expressed or implied by such
forward-looking statements. Moleculin has attempted to identify
forward-looking statements by terminology including 'believes,'
'estimates,' 'anticipates,' 'expects,' 'plans,' 'projects,'
'intends,' 'potential,' 'may,' 'could,' 'might,' 'will,' 'should,'
'approximately' or other words that convey uncertainty of future
events or outcomes to identify these forward-looking statements.
These statements are only predictions and involve known and unknown
risks, uncertainties, and other factors, including those discussed
under Item 1A. "Risk Factors" in our most recently filed Form 10-K
filed with the Securities and Exchange Commission ("SEC") and
updated from time to time in our Form 10-Q filings and in our other
public filings with the SEC. Any forward-looking statements
contained in this release speak only as of its date. We undertake
no obligation to update any forward-looking statements contained in
this release to reflect events or circumstances occurring after its
date or to reflect the occurrence of unanticipated events.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
MBRX@jtcir.com
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SOURCE Moleculin Biotech, Inc.