HOUSTON, July 2, 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 an update on its clinical development plan for
Annamycin.
After consultation with both US and European regulatory
agencies, Moleculin has mapped out a course for development of
Annamycin for the treatment of relapsed or refractory acute myeloid
leukemia ("AML"). In its End of Phase 1 meeting with the US
Food and Drug Administration ("FDA") the Company agreed to expand
its protocol-mandated testing for cardiotoxicity throughout the
remainder of its European Phase 1 trial. The expansion of testing
will provide additional safety data, investigating the continued
evidence of little to no cardiotoxicity, and efficacy data that
both US and European regulators may consider as the Company
prepares to transition to a Phase 2 clinical trial, which
management believes will focus on Europe.
Moleculin has now received approval from European authorities to
increase the increment for dose-escalation from 30
mg/m2 per cohort to 60 mg/m2 per cohort, as
treatment to date in its clinical trials has been at what the
Company considers to be subtherapeutic levels. The first
patient in the European trial has now been treated at 240
mg/m2 with no evidence of cardiotoxicity or other dose
limiting toxicities. Once 2 more patients are successfully
treated at this level, the next cohort will be treated with 300
mg/m2. With these timing and dosing expectations, the
Company believes that European dosing will increase in 2020,
allowing a recommended Phase 2 Dose to be established in 2021.
"Based on what we know from prior clinical trials, we think it
may require a dose level of 300 to 360 mg/m2, or
possibly higher, before we begin to see a solid therapeutic window
for Annamycin in AML," commented Walter
Klemp, Chairman and CEO of Moleculin. "Now, with 5 clinical
sites open in Poland, the European
trial is in the best position to complete the safety portion of our
development. That also allows us to close out the US trial, which
has already reached its primary safety endpoint."
The Company intends to use what it learns from the Phase 1
clinical trials in AML to inform the starting dosage in clinical
testing of Annamycin for the treatment of lung metastases, for
which it hopes to file an Investigational New Drug application or
its European equivalent by the end of this year.
Mr. Klemp concluded: "With the confirmation of animal model
activity in lung metastases we just announced last week, we are
pushing hard to prepare to seek regulatory approval to begin a
Phase 1 clinical trial in sarcomas that have metastasized to the
lungs, a condition for which there is a significant unmet
need."
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, being studied for brain tumors, pancreatic cancer and
hematologic malignancies; and WP1220, an analog to WP1066, being
studied 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, such as WP1122. Moleculin has
the exclusive worldwide rights (subject to certain territories for
which it has issued sublicenses) to all of the above
technologies.
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 to establish a
recommended Phase 2 Dose in 2021, the final dose level of such
recommended Phase 2 Dose, the ability of Annamycin to show safety
and efficacy in patients, and the ability of the Company to file an
investigative new drug application or its European equivalent by
the end of this year 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
646-536-7028 /
7000
jsalierno@theruthgroup.com
cruth@theruthgroup.com
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SOURCE Moleculin Biotech, Inc.