HOUSTON, Oct. 21, 2020 /PRNewswire/ -- Moleculin
Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a
clinical stage pharmaceutical company with a broad portfolio of
drug candidates targeting significant unmet needs in the treatment
of tumors and viruses, announced results from an independent
laboratory validating internal animal studies showing the ability
of Annamycin to target lung localized tumors.
Walter Klemp, Chairman and CEO of
Moleculin, stated, "This is some of the most compelling data we
have seen yet to support our plans for a clinical trial evaluating
the potential for Annamycin to treat lung metastatic tumors. There
is an extreme unmet need for a more effective treatment of sarcomas
that have metastasized to the lungs, and we intend for this to be a
primary focus of our next IND for Annamycin. The timing of
this new information is particularly encouraging, considering the
progress we reported from our recent Pre-IND meeting with the
FDA. We are hopeful we can submit this IND before
year-end."
The relevance of targeting lung localized tumors is that it
could provide a means to address a significant unmet need in cancer
therapy. Specifically, there are limited treatment options
for lung metastases resulting from a primary tumor, even though the
primary tumor may have been treatable. For example, a primary
soft tissue sarcoma can often be initially successfully treated
(most often by removal), but if it has spread to the lungs, the
anthracycline Adriamycin (doxorubicin), the approved treatment for
patients whose lung-localized metastases cannot be surgically
removed, has only limited efficacy. Research sponsored by
Moleculin and recently presented at the American Association of
Cancer Research (AACR) Annual Meeting held from June 22nd-24th, 2020 suggested a possible reason
for this limited efficacy may be the inability of doxorubicin to
sufficiently accumulate in the lungs in concentrations required to
kill tumor cells. That presentation included findings from
preliminary animal studies demonstrating that Moleculin's drug
candidate Annamycin, a more potent and non-cardiotoxic
anthracycline, was capable of accumulating in the lungs of mice at
up to 6-fold higher concentrations than doxorubicin.
The latest studies conducted in rats validated the previous
animal studies presented at AACR. Additionally, these experiments
compared both Free Annamycin (F-Anna) and Liposomal Annamycin
(L-Anna) with doxorubicin (Dox), which is the current standard of
care for sarcomas and other human malignancies including some that
have metastasized to the lungs. The purpose of testing F-Anna
(the non-liposomal form of Annamycin) was to determine whether the
observed uniquely high accumulation of Annamycin in the lungs was
due to its liposomal formulation (L-Anna) or whether it is an
inherent property of Annamycin itself. The preliminary
results show that F-Anna accumulates in the lungs of rats to a
concentration 9-fold higher than Dox, demonstrating that the
differences in molecular structure of Annamycin when compared to
doxorubicin are responsible for Annamycin's comparatively high
accumulation in lungs and, we believe, consequently should enable
an ability to target tumor cells in the lungs. In addition to
the unique properties of the free drug Annamycin, the liposomal
formulation further increased accumulation in the lungs and the
noted concentration was more than 30-fold higher than Dox. In
summary, we believe the apparent ability of the liposomal
formulation of Annamycin to further enhance the natural ability of
free Annamycin to accumulate in lungs without any observed toxic
side effects creates a highly promising anticancer agent that may
be uniquely capable of targeting lung localized tumors.
Mr. Klemp concluded, "Although our focus has been on the
potential to treat sarcoma lung metastases with Annamycin, we
should also point out that the indications for Annamycin might be
expanded and could include lung metastatic breast cancer, colon
cancer, prostate cancer, bladder cancer, and neuroblastoma.
Our animal studies have already demonstrated the ability of
Annamycin to significantly increase survival of mice in lung
localized triple negative breast cancer and colon cancer
models.
As a part of our general approach to anticancer drug design, we
are currently also exploring the possibility of targeting other
organs that can be considered 'sanctuary sites of cancer'. In
our opinion, our additional data continues to point to the
potential for Annamycin to become an important drug in a wide range
of cancers, especially in light of its lack of cardiotoxicity,
which is being demonstrated in our ongoing clinical trials for
AML."
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 be
shown safe and effective for the treatment of cancer and the
ability of the Company to submit an Investigational New Drug (IND)
application before year-end, and to secure IND status for Annamycin
for the treatment of lung metastases. 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.