HOUSTON, Oct. 22, 2019 /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, today announced
the expansion of Annamycin production commitments in response to
management's assessment of positive AML clinical trial activity and
the potential expansion of indications for use to include
lung-localized tumors. The purchase commitment arranged through
Davos Pharmaceuticals includes moving final production of Annamycin
to a larger-scale suite within BSP Pharmaceuticals S.p.A. ("BSP")
in Latina, Italy. Until now, BSP
has been producing the clinical supplies of Annamycin in a smaller
pilot-scale suite.
"Our clinical trials of Annamycin in relapsed and refractory
acute myeloid leukemia ("AML") have been going better than
expected, as it now appears we will be able to reach a higher
maximum tolerable dose than what was established in previous
clinical trials," commented Walter
Klemp, Moleculin's Chairman and CEO. "That not only
increases our chances for improved patient outcomes, it places a
higher demand on drug supply. Coupled with the recent discovery in
animal models that Annamycin may be well suited to treat
lung-localized tumors because of its ability in such models to
accumulate in the lungs at nearly 6 times the level of the current
standard of care anthracycline, we are clearly going to need more
drug."
Dr. Donald Picker, Moleculin's
Chief Science Officer added: "With management's view of success in
clinic and the expectation of wider demand resulting from
additional clinical trials in lung-localized tumors, it's time for
Moleculin to start preparing for an eventual drug approval process.
That requires the development and validation of commercial scale
methods and this move with BSP marks the beginning of that process.
In addition to increasing the scale of clinical supply production,
we will be working with BSP and with our manufacturer of API to
develop the commercial scale synthesis and drug production methods
we will need to ultimately prepare for New Drug
Approval."
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. 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 additional
Immune/Transcription Modulators, as well as 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
show safety and efficacy in patients and the ability of the Company
and its contractors to develop commercial scale production of
Annamycin and to 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 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. The
Company cautions investors not to place undue reliance on the
interim results announced today.
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SOURCE Moleculin Biotech, Inc.