HOUSTON, May 25, 2021 /PRNewswire/ -- Moleculin
Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a
clinical stage pharmaceutical company with a broad portfolio of
drug candidates targeting highly resistant tumors and viruses,
today announced it has received clearance to initiate its Phase
1b/2 clinical trial evaluating
Annamycin for the treatment of soft tissue sarcoma (STS) lung
metastases. The first of several planned clinical sites is now open
and the Company expects to begin patient enrollment.
Soft tissue sarcomas are the most common form of sarcoma,
accounting for an estimated 130,000 incident cases per year
worldwide. While many sarcomas can be addressed through surgical
removal, it is estimated that as many 20% to 50% of STS sarcomas
will eventually metastasize to the lungs, where treatment can
become more challenging. Recently published animal data suggests
that the efficacy of the current standard of care chemotherapy
(doxorubicin) may be limited due to its inability to accumulate
sufficiently in the lungs. The use of doxorubicin and other
currently approved anthracyclines for STS lung metastases is
further limited due to their inherent cardiotoxicity, which limits
the amount of anthracycline that can be given to
patients.
Annamycin is the Company's next-generation anthracycline that
has been shown in animal models to accumulate in the lungs at up to
30-fold the level of doxorubicin. Importantly, Annamycin has also
demonstrated a lack of cardiotoxicity in recently conducted human
clinical trials for the treatment of acute myeloid leukemia (AML),
and the Company believes that the use of Annamycin may not face the
same usage limitations imposed on doxorubicin. Annamycin is
currently in development for the treatment of AML and STS
lung metastases.
"We remain dedicated to advancing this program forward and are
pleased to have received clearance to begin patient enrollment.
With the data seen to-date, we believe Annamycin has the potential
to be the first non-cardiotoxic anthracycline and address the
limitations with current treatment options. Our clinical teams are
diligently working to complete additional site initiations and get
patient enrollment and dosing underway as efficiently and
expeditiously as possible," commented Walter Klemp, Chairman and CEO of Moleculin.
The Phase 1b/2 study is a a
multi-center, open-label, single-arm study that in Phase
1b will determine the maximum-
tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) and
safety of Annamycin and in Phase 2 will explore the efficacy of
Annamycin as a single agent for the treatment of subjects with STS
with lung metastases for which chemotherapy is considered
appropriate. A minimum of 3 subjects for each dosing cohort will be
enrolled in the Phase 1b portion of
the study until an MTD is identified. A maximum of 25 subjects will
be enrolled at the RP2D to further evaluate efficacy.
Based on a recently announced reimbursement grant awarded in
Poland, the Company also expects a
second Phase 1b/2 clinical trial of
Annamycin in sarcoma lung metastases to be initiated in 2021, which
will be primarily investigator-funded in Europe.
Annamycin has been granted Fast Track Status and Orphan Drug
Designation from the U.S. Food and Drug Administration for the
treatment of STS lung metastases.
For more information about the Phase 1b/2 study evaluating Annamycin for the treatment
of STS lung metastases, please visit clinicaltrials.gov and
reference identifier NCT04887298.
About 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 and
viruses. The Company's clinical stage drugs are: Annamycin, a
next-generation anthracycline, designed to avoid multidrug
resistance mechanisms with little to no cardiotoxicity being
studied for the treatment of relapsed or refractory acute myeloid
leukemia, more commonly referred to as AML, 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 cancer
and hematologic malignancies, and WP1220, an analog to WP1066, for
the topical treatment of cutaneous T-cell lymphoma. Moleculin is
also engaged in preclinical development of additional drug
candidates, including other Immune/Transcription Modulators, as
well as WP1122 and related compounds capable of
Metabolism/Glycosylation Inhibition.
For more information about the Company, please visit
http://www.moleculin.com.
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. Forward-looking statements in this press
release include, without limitation, the ability of Annamycin to
demonstrate safety and efficacy in patients, the ability of the
investigator initiated clinical trial in Europe for STS to commence later this year,
the ability of clinical trials to begin recruiting patients on a
timely basis, the timing of the disclosure of interim data, and
whether Annamycin will receive New Drug Approval. 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.