Full Press Release Details
Announces Preparation to File an IND with the FDA for WP1220 for Treatment of Cutaneous T-Cell Lymphoma
HOUSTON - June 13, 2017 - Moleculin
Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused
on the development of anti-cancer drug candidates, some 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 begun taking steps to file an IND with the FDA for its molecule
WP1220 for the treatment of Cutaneous T-Cell Lymphoma (CTCL), a rare form of skin cancer.
Moleculin's WP1220 (aka MOL4239)
has data demonstrating significant activity in preclinical studies and is being studied as a possible topical treatment for CTCL.
The FDA previously granted an IND to WP1220 for development as a topical treatment of psoriasis, and although the molecule completed
a Phase I clinical trial, providing initial data suggesting safety in humans, Phase II clinical trials did not demonstrate sufficient
activity to warrant further development for that indication. To pursue further development of WP1220, the Company believes the
data used to support the prior IND may allow for a quicker pathway to an IND for CTCL.
"Our primary focus has been further
developing our most advanced and promising drug, Annamycin, for the treatment of acute myeloid leukemia," commented Walter
Klemp, Chairman and CEO of Moleculin. "Nevertheless, we believe some of the less advanced technologies in our portfolio have
significant potential in other cancer indications. WP1220 is a great example of such potentially useful technology, and because
the FDA previously found the data package supporting an IND for WP1220 to be adequate in another context, we are hopeful that we
can expeditiously move forward to studying the molecule in humans for the topical treatment of this potentially deadly skin disease."
Mr. Klemp added: "Developing WP1220
for indications like CTCL may provide opportunities for strategic collaboration and out-licensing while maintaining our ability
to develop other molecules to their highest and best potential. We will be actively looking for such opportunities to help fund
the projects we believe hold the most potential for Moleculin stakeholders."
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About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical
pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at
M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline being studied
for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical
small molecule development portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms
and the recruitment of the patient's own immune system, and the other of which targets the metabolism of tumors.
For more information about Moleculin, 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 Company's ability to timely prepare an IND for WP1220 based on prior
data, FDA permitting the Company sponsored IND for WP1220 to go into effect, the ability of WP1220 to show activity in a CTCL clinical
trial and the ability of other molecules in the WP1066 portfolio to show activity in other cancers, and the ability of Moleculin
to create and/or derive funding from strategic collaboration and out-licensing arrangements. These statements relate to future
events, future expectations, plans and prospects. 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.
Chief Operating Officer