HOUSTON, Aug. 20, 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, today announced
approval by the Emory University
Clinical Trial Review Committee (CTRC) to move forward with an
Investigator Initiated clinical trial of Moleculin's
immune-stimulating/transcriptional-modulator, WP1066, for the
treatment of pediatric brain tumors. The trial will take place at
the Aflac Cancer and Blood Disorders Center at Children's
Healthcare of Atlanta.
"Continued progress with the MD Anderson clinical trial of WP1066 in brain
tumors has now cleared the way for a pediatric brain tumor trial
with investigators from Emory University
School of Medicine," commented Walter Klemp, Moleculin's Chairman and
CEO. "With CTRC approval, the investigators can now submit a
request for IND from the FDA for this indication referencing the MD
Anderson IND already in
place. Consistent with one of our stated development
milestones, we continue to expect this IND to be submitted before
year end."
Dr. Tobey MacDonald, Professor of the Department of Pediatrics
at Emory University School of Medicine,
Director of Pediatric Neuro-Oncology at Aflac Cancer and Blood
Disorders Center and Principle Investigator for this clinical trial
commented: "We've done a lot of preclinical research suggesting
that WP1066 may be beneficial in treating pediatric brain tumors,
including medulloblastoma, where there continues to be a critical
unmet need for more effective therapies. We are excited to
finally get this trial moving."
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 WP1066 to show
safety and efficacy in humans. 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.