HOUSTON, Feb. 8, 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 that the Agencja Badań Medycznych (The Medical
Research Agency) a Polish state agency responsible for development
of scientific research in the field of medical and health sciences,
awarded a grant equivalent to $1.5 million
USD to the Maria Sklodowska-Curie National Research
Institute to fund a Phase 1B/2
clinical trial of Annamycin for the treatment of soft tissue
sarcoma (STS) lung metastases. The grant-funded clinical
trial will be led by Prof. Piotr
Rutkowski, MD, PhD, Head of Department of Soft Tissue/Bone
Sarcoma and Melanoma at the Maria Sklodowska-Curie National
Research Institute of Oncology in Warsaw,
Poland.
Prof. Piotr Rutkowski will be
assisted in part, by WPD Pharmaceuticals in Poland, a licensee of Annamycin, who will
provide support in preparation for and conduct of the clinical
trial, which is expected to begin this year. As a part of the
collaboration between Moleculin and Prof. Rutkowski, Moleculin will
be supplying the drug product necessary for the clinical trial, but
Moleculin will not participate in conducting the clinical
trial. This trial is independent from and will be in addition
to the US clinical trial Moleculin is planning to conduct with
Annamycin in sarcoma lung metastases.
"There is a significant unmet need for improved treatments for
patients with sarcoma lung metastases," commented Prof.
Piotr Rutkowski of Maria
Sklodowska-Curie National Research Institute of Oncology, "so we
are excited to begin this trial. Although this is considered
a rare disease, there are no other clinical trials of this kind
currently active in Poland, so
it's a tremendous opportunity for our patients."
"Prof. Rutkowski's trial is a key element in a collaboration
between teams in the US and Poland," added Walter
Klemp, Chairman and CEO of Moleculin. "We are hopeful that
data from the US and Poland can be
combined to identify the potential for Annamycin to treat 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 20% to 50% of STS
sarcomas will eventually metastasize to the lungs, where treatment
can become more challenging.
Once metastasized to the lungs, if tumors cannot be surgically
removed, the primary chemotherapy regimen is the anthracycline
doxorubicin (also known as Adriamycin). While 10% to 30% of
patients with sarcoma lung metastases may initially respond to
doxorubicin, most will relapse leaving the majority of these
patients without an alternative chemotherapy. Treatment
options are further limited because of the inherent cardiotoxicity
of currently approved anthracyclines, including doxorubicin, which
limits the amount of anthracycline that can be given to
patients.
Annamycin is a "next generation" anthracycline that has recently
been shown in animal models to accumulate in the lungs at up to 34
times 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,
so the use of Annamycin may not face the same dose limitations
imposed on doxorubicin.
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 and the ability of the
clinical trial to recruit patients on a timely basis. 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.
Contacts
James Salierno / Carol Ruth
The Ruth Group
973-255-8361 / 917-859-0214
jsalierno@theruthgroup.com
cruth@theruthgroup.com
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SOURCE Moleculin Biotech, Inc.