HOUSTON, June 21, 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 commenced enrollment and dosed the first
subject in its U.S. Phase 1b/2
clinical trial evaluating Annamycin for the treatment of soft
tissue sarcoma (STS) lung metastases.
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 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.
"We are pleased to have commenced patient enrollment and dosing
in this important program evaluating Annamycin, which we believe
has the potential to address the limitations with current treatment
options for STS lung metastases. Our team is commited to driving
continued progress for the development of Annamycin. We look
forward to getting the trial well-underway toward interim data and
potentially address the unmet medical needs in the treatment of
these highly resistant tumors," commented Walter Klemp, Chairman and CEO of Moleculin.
The Phase 1b/2 study is a a U.S.
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.
"With limitations in the current treatment landscape for STS,
there remains significant unmet need for patients and physicians.
We are pleased to see the progress of this important study to
evaluate Annamycin, which has demonstrated a lack of cardiotoxicity
in recent human clinical trials, one of which is ongoing. I
continue to be encouraged by the data seen to date and look forward
to the continued advancements of this study toward offering
potential hope to patients battling this difficult to treat
cancer," added Sant P. Chawla MD,
Director, Sarcoma Oncology Center, Director, Cancer Center Of
Southern California.
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.
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 drug
candidates for the treatment of highly resistant 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. Forward-looking statements in this press
release include, without limitation, the ability of Annamycin to
demonstrate safety and efficacy in patients, the ability of
clinical trials to begin recruiting patients on a timely basis, the
timing of the disclosure of interim data in the second half of
2022, 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.