Moleculin Announces the FDA has Granted Orphan Drug Designation for its Brain Tumor Drug
February 05 2019 - 7:30AM
Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the
"Company"), a clinical stage pharmaceutical company focused on the
development of oncology drug candidates, all of which are based on
license agreements with The University of Texas System on behalf of
the M.D. Anderson Cancer Center, today announced that the US Food
and Drug Administration (FDA) has granted Orphan Drug Status for
its drug candidate WP1066 for the treatment of glioblastoma, the
most aggressive form of brain tumor.
“We continue to be encouraged by the progress of
the physician-led clinical trial of WP1066,” commented Walter
Klemp, Moleculin’s Chairman and CEO, “and, now having the FDA grant
Orphan Drug status for WP1066 positions us well for potential
marketing of this drug. We believe that WP1066 represents a
new class of drugs which we call ‘Immune/Transduction Modulators’
because it has demonstrated the ability in preclinical testing in
animals to both stimulate a natural immune response to tumors and
directly attack tumor cells by inhibiting multiple key oncogenic
transcription factors, including STAT3, HIF1-α and c-Myc.”
Dr. Sandra Silberman, Chief Medical Officer for
New Projects at Moleculin added: “The development of WP1066 is
gaining momentum. In addition to the glioblastoma trial at MD
Anderson, we have had interest from additional investigators,
including Emory University and Mayo Clinic for conducting clinical
trials for the treatment of pediatric brain tumors, as well as
others interested in treating a range of highly resistant tumors
including AML and pancreatic cancer. Because we’ve seen
strong anti-tumor activity in a wide range of animal models, we
believe this represents an important new approach to treating many
types of cancer.”
The FDA grants orphan drug designation to drugs
and biologics that are intended for the treatment of rare diseases
that affect fewer than 200,000 people in the U.S. Orphan drug
status is intended to facilitate drug development for rare diseases
and may provide several benefits to drug developers, including tax
credits for qualified clinical trials costs, exemptions from
certain FDA application fees, and seven years of market exclusivity
upon regulatory product approval.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage
pharmaceutical company focused on the development of oncology drug
candidates, all of which are based on discoveries made at M.D.
Anderson Cancer Center. The Company’s clinical stage drugs are
Annamycin, an 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, and WP1066, an immuno-stimulating
STAT3 inhibitor targeting brain tumors, pancreatic cancer and AML.
Moleculin Biotech is also engaged in preclinical development of
additional drug candidates, including additional STAT3 inhibitors
and compounds targeting the metabolism of tumors.
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
Biotech 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.
ContactsJoe Dorame, Robert Blum or Joe
DiazLytham Partners, LLC602-889-9700mbrx@lythampartners.com
Moleculin Biotech (NASDAQ:MBRX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Moleculin Biotech (NASDAQ:MBRX)
Historical Stock Chart
From Sep 2023 to Sep 2024