HOUSTON, Oct. 1, 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 preliminary first cohort data from
the Emory University
physician-sponsored clinical trial being conducted at the Aflac
Cancer and Blood Disorders Center at Children's
Healthcare of Atlanta by Dr. Tobey MacDonald, Professor of
Pediatrics and Director of the Pediatric Neuro-Oncology
Program. He is studying the use of
WP1066 (AflacST1901), a proprietary Moleculin drug
candidate, as a potential treatment for childhood
brain tumors. The first three patients in the trial received
treatment at a dose level of 4 mg/kg with no adverse events related
to WP1066 and the study will now proceed to the next higher dose of
6 mg/kg. One of these patients with diffuse
intrinsic pontine glioma (DIPG), showed an apparent response to the
treatment with both clinical improvement and radiologic reduction
of tumor size.
Dr. MacDonald stated, "We are very pleased that this trial has
successfully completed the first cohort without any safety issues
and will now progress to the second cohort at an escalated dose
level. We must, of course, be very careful not to draw any
conclusions from such preliminary data, but to have an
objective response in a DIPG patient is frankly,
unexpected."
Mr. Walter Klemp, Chairman and
CEO of Moleculin, "When you look at the clinical trial history of
DIPG, despite approximately 200 clinical trials, no drug has shown
significant activity in this disease, so we find this initial
activity particularly encouraging. WP1066 is an
immuno-stimulating p-STAT3 inhibitor and has been shown to
stimulate immune responses that successfully modulate oncogenic
transcriptional activity in tumor cells and repress their ability
to drive tumor growth. Coupled with the activity we have
recently seen with WP1220, a close analog to WP1066, in its proof
of concept clinical trial for the topical treatment of cutaneous
t-cell lymphoma, we are more committed than ever to determine the
full potential of this new class of p-STAT3 inhibitors. We
now have six drug candidates, with three of them showing human
activity, so we need to be careful not to confuse this p-STAT3
inhibitor pipeline with the recent announcement regarding our
antimetabolites and their potential to treat viruses. We have
placed a high priority on reducing risk for our investors by
creating what we call 'multiple shots on goal,' and the events of
this week are showing just how effective that strategy has
been."
Mr. Klemp concluded, "Consistent with our history of providing
clinical trial updates on a cohort-by-cohort basis, we look forward
to updating investors on the continued progress of this trial as
additional cohorts are completed. For more information
regarding the design of this study, please refer to
https://clinicaltrials.gov/ct2/show/NCT04334863."
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 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.