HOUSTON, April 28, 2020 /PRNewswire/ -- Moleculin
Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a
clinical stage pharmaceutical company with a broad portfolio of
drug candidates, today announced that it is now authorized by the
Polish Department of Registration of Medicinal Products known as
URPL to accelerate the Phase 1 dose escalation portion of its
clinical trial of Annamycin for the treatment of acute myeloid
leukemia (AML).
The URPL has allowed an amendment to the Annamycin clinical
trial protocol, which among other things, includes an increase in
the dose escalation increment between cohorts from 30
mg/m2 to 60 mg/m2. The clinical trial is
currently recruiting for the 240 mg/m2 cohort, so this
amendment allows the next cohort to increase to 300
mg/m2, assuming all requirements for safety are met with
the 240 mg/m2 cohort.
"Now that we have begun to demonstrate the absence of any
cardiotoxicity associated with Annamycin," commented Walter Klemp, Chairman and CEO of Moleculin. "We
believe we can and should move more aggressively to establish the
maximum tolerated dose, or MTD, for Annamycin. This authorization
now sets the stage to accelerate the dose escalation process. Thus
far, even though we've seen promising activity from Annamycin, our
dosing levels are still sub-therapeutic. Based on prior clinical
experience with Annamycin, the 300 mg/m2 dosing level
will be our first opportunity to test Annamycin at what we expect
will be therapeutic levels."
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, under
investigation for brain tumors, pancreatic cancer and hematologic
malignancies; and WP1220, an analog to WP1066, being developed 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 WP1122, a compound capable of metabolism/glycosylation
disruption.
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 humans and the dosing level
required to achieve therapeutic levels. 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.