HOUSTON, Dec. 17, 2020 /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 US Food and Drug Administration (FDA) is allowing the company's
Investigational New Drug (IND) application to study Annamycin for
the treatment of soft tissue sarcoma lung metastases to go into
effect. This allows Moleculin to begin a Phase 1B/2 clinical trial in the US for patients with
soft tissue sarcoma that has metastasized to the lungs after
first-line therapy for their disease.
It is estimated that there are approximately 36,000 new cases of
soft tissue sarcoma (STS) in the 7 major markets (US, EU5 and
Japan) each year, and an estimated
annual market size of over $177
million for the treatment of STS lung metastases. Our
clinical advisors estimate that approximately half of all STS
patients will eventually develop lung metastases from their primary
tumor. Although first-line treatments such as surgical
resection, chemotherapy and radiation may provide initial
therapeutic benefit for an estimated 35% of those patients, there
are no approved or emerging second-line therapies for the remaining
65% who relapse or are refractory. Although the lungs tend to
be a major site of relapse, we are aware of only 2 active clinical
trials specifically targeting STS lung metastases, indicating that
Annamycin faces limited competition in this area of
development.
Moleculin recently announced that Annamycin demonstrates
consistently high antitumor activity in vivo in all tested animal
models of different types of lung-localized cancers, including
sarcoma. These promising findings correlate with surprisingly high
uptake of Annamycin to the lungs in animal models. This uptake is
up to 34-fold higher than that of doxorubicin, the primary
first-line chemotherapy for STS. The limited pulmonary uptake
of doxorubicin in animal models may help explain its lack of
activity against STS lung metastases in humans. Additionally,
clinical data show no cardiotoxicity associated with the use of
Annamycin, as well as the ability to avoid multidrug resistance
mechanisms, both of which are often treatment-limiting effects of
anthracyclines (which includes doxorubicin) in this
setting. Taken together, these factors suggest that
Annamycin could represent an important treatment to help address a
significant unmet need in patients with STS lung
metastases.
"Since the discovery in animal models of Annamycin's
effectiveness in lung metastases, we have been moving quickly to
begin a clinical trial in the US to study Annamycin for this
indication," commented Walter Klemp,
Chairman and CEO of Moleculin. "Recognizing the importance of
building on the results with human clinical data, we preemptively
included this upcoming trial as part of our budget plan, so our
anticipated cash runway into the third quarter of 2021 remains
unchanged. We are also collaborating with our partners and
physicians in Poland who have
shown a high level of interest in testing Annamycin in STS lung
metastases and are currently pursuing a possible investigator-led
clinical trial in Europe. It
is our goal to have to have our US clinical trial begin by
mid-2021, with the possibility of also initiating a European
investigator-funded clinical trial in 2021."
Mr. Klemp concluded: "Along with the results in STS lung
metastases, our animal models have shown significant activity in
other lung metastases, including colorectal and triple negative
breast cancer, as well as meaningful concentration levels of
Annamycin in the liver, spleen and pancreas. Additionally,
when tested in a highly aggressive AML mouse model, Annamycin
significantly reduced tumor burden in the spleen, lungs and liver,
leading to a significant increase in survival. Based on this
promising preclinical data, we believe the ultimate market
opportunity for Annamycin could be much larger than just STS lung
metastases. For all these reasons, we are excited to be
moving from the animal models to clinical study."
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 the Company to
begin a clinical trial in the US by mid-2021 or the ability of an
Investigator-funded trial to begin in Europe during 2021, the ability of Annamycin
to demonstrate safety and efficacy in patients, and the Company's
estimated cash runway. 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 Biotech 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.