HOUSTON, Nov. 12, 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 that
the FDA has approved a request for Investigational New Drug ("IND")
status for its drug candidate WP1066 to be used in a Phase 1
clinical trial for the treatment of children with recurrent or
refractory malignant brain tumors. The request was made by
physician researchers at Emory
University, including 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. The trial will be conducted at the
Aflac Cancer and Blood Disorders Center at Children's Healthcare of
Atlanta.
"This FDA approval gives a green light for Emory University to begin an important clinical
trial to explore a new approach to treating pediatric brain
cancer," commented Walter Klemp,
Moleculin's Chairman and CEO. "WP1066 is currently in a
clinical trial for adult patients with glioblastoma and melanoma
metastases to the brain at MD Anderson Cancer Center, and this is a
logical extension of that research. WP1066 is an inhibitor of
the activated form of a protein called STAT3, a target that has
been implicated in a wide range of highly resistant cancers.
Preclinical research at Emory
University indicated that WP1066 had a significant
anti-tumor effect on medulloblastoma cell lines, so there is a lot
of encouragement regarding the opportunity to provide new hope for
treating this rare condition."
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 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.