HOUSTON, Oct. 13, 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 additional preliminary data from the Phase 1
clinical trial of its immuno-stimulating STAT3 inhibitor, WP1066,
in patients with glioblastoma (GBM). This supports the
progression of the trial to the fourth and final dose escalation
cohort. Three patients have completed treatment in the third
cohort at a dose level of 8 mg/kg with no adverse events related to
WP1066 and the study will now proceed to the next higher dose of 16
mg/kg.
Walter Klemp, Chairman and CEO of
Moleculin, stated, "On the heels of our recent positive
announcement regarding the progress of the pediatric brain tumor
trial of WP1066, we are pleased to also report on the progress of
the adult GBM clinical trial for the same drug candidate. The
trial in adults has been important in leading the way to
establishing a safe and tolerable human dose level for what we
believe is a first-in-class compound that crosses the blood-brain
barrier and is being developed for the treatment of central nervous
system malignancies. In animal models, WP1066 has been shown
to stimulate immune responses that successfully modulate oncogenic
transcriptional activity in tumor cells and repress their ability
to drive tumor growth."
Mr. Klemp continued: "In addition to providing valuable
pharmacokinetic data, this trial also creates the foundation for
future studies in WP1066, including another investigator-initiated
study, which is currently being proposed to examine the combination
of WP1066 with radiation for the treatment of GBM. This next
clinical trial is being proposed as a result of recent discoveries
presented in a peer-reviewed article published in Clinical Cancer
Research (Clin Cancer Res June 30
2020 DOI:10.1158/1078-0432.CCR-19-4092), which reported findings
that Moleculin's STAT3 inhibitor, WP1066, used in combination with
traditional whole brain radiation therapy, resulted in long-term
survivors and enhanced median survival time relative to monotherapy
in mice with implanted human brain tumors."
Mr. Klemp concluded, "In keeping with our established clinical
trial reporting policies, we look forward to updating investors on
the continued progress of this trial once this final cohort is
completed."
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 WP1066 as a single
agent and in combination with radiation therapy to be shown safe
and effective for the treatment of brain tumors. 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.