Moleculin Announces FDA Filing for Orphan Drug Designation for Glioblastoma Drug
December 06 2018 - 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 it has filed a
request with the U.S. Food and Drug Administration (“FDA”) for
Orphan Drug Status for its drug candidate WP1066.
“Clinical progress with WP1066 has been
encouraging,” commented Walter Klemp, Moleculin’s Chairman and CEO.
“Given its potential to address rare and difficult to treat
cancers, including glioblastoma, we believe WP1066 is well
positioned to qualify for Orphan Drug Status.”
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 and the ability of
WP1066 to qualify for and be granted Orphan Drug Status. 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
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