HOUSTON, Nov. 19, 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, announced it now
has preliminary data from its clinical trial of WP1220 for the
treatment of cutaneous T-cell lymphoma ("CTCL"), which was
published in Blood in conjunction with the American Society
of Hematology Annual Meeting and Exposition to be held December 7-10, 2019.
"For years, p-STAT3 (the activated form of STAT3) has been
considered an 'undruggable' target because of the difficulty of
reaching and affecting this cell-signaling protein," commented
Walter Klemp, Moleculin's Chairman
and CEO. "Some consider it to be a master regulator of
cancer-related gene transcription, so we believe the ability to
show a therapeutic effect from a p-STAT3 inhibitor could be
considered a significant breakthrough in cancer research."
Results: There were 6 patients screened, and 5
patients enrolled between March and July
2019. Three are evaluable for both safety and efficacy after
completing 3 months of treatment, with 2 ongoing and evaluable for
safety. The only AE reported potentially related to study drug in
one of the five patients was a mild contact dermatitis not
requiring treatment. CAILS scores on index lesions were
significantly decreased in the first 3 patients, who were stages
IA, IB, and IIB, respectively, at entry. A composite score was
obtained for all treated lesions for each patient, and percent
changes were calculated from baseline to Day 84. There was a median
reduction of 70.8% (range 62.1%-76.2%) for the 3 patients.
Improvement was noted as early as 7 days after initiation of
treatment, and maintenance of improvement was also shown at follow
up (1 month after discontinuation, as per protocol). The fourth
patient has also shown an initial reduction in the composite CAILS
score after 56 days (26.7%), and is continuing on treatment.
Evaluations of the biopsy samples for histopathology and status of
p-STAT3 in treated lesions are in progress.
Conclusions: WP1220, an inhibitor of p-STAT3, has
shown demonstrable safety and significant efficacy after at least 3
months of topical treatment in 3 patients with progressive MF, with
a continuing trend towards improvement in additional patients
currently in treatment. This is the first demonstration that
inhibition of the STAT3 activation pathway with topical therapy has
impacted the course of this disease. The trial is continuing, and
updated and more comprehensive data from this study as well as
assessment of STAT3 phosphorylation in treated lesions will be
reported.
Dr. Sandra Silberman, Chief
Medical Officer for New Projects at Moleculin, added: "This is the
first topical delivery of a p-STAT3 inhibitor that we know of for
CTCL, where there is a significant unmet need for improved
treatment of the lesions associated with this potentially deadly
skin cancer. But, we believe the significance of this data
goes well beyond CTCL, as it speaks to the targeting of p-STAT3 as
a general strategy. We are excited to share these preliminary
results in association with ASH, especially because we believe
showing activity here could have exciting implications for the
future of STAT3 inhibitors in general. Although this is a
relatively small pilot study, we believe the results justify an
expansion to a larger patient population in a Phase 2 clinical
trial."
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 WP1220 to show
safety and efficacy in patients. 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.