Moleculin Seeks Approval from Polish Regulatory Agency for Skin Cancer Clinical Trial
August 09 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 submitted a
request to Polish authorities for clinical trial authorization
(“CTA”) for its STAT3 inhibitor, WP1220, for the treatment of
Cutaneous T-Cell Lymphoma (“CTCL”).
“This request for CTA, if approved, will give us our third drug
in clinic,” commented Walter Klemp, Chairman and CEO of Moleculin.
“Published research supports the belief that Cutaneous T-Cell
Lymphoma, a deadly form of skin cancer, may be highly dependent on
the upregulation of the activated form of STAT3. We believe
WP1220 may be ideally suited as a topical agent to inhibit STAT3
and therefore could potentially become a valuable new drug for the
treatment of CTCL.”
A request for CTA in Poland is the equivalent of a request for
Investigational New Drug (“IND”) status in the U.S. This
follows the Company’s announcement in June of this year of the
approval of a CTA in Poland for its drug Annamycin for the
treatment of acute myeloid leukemia (“AML”).
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. Our 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 primary brain tumors and brain metastases,
pancreatic cancer and hematological malignancies. We are 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
WP1220 to receive CTA approval in Poland. 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.
ContactsJoe Dorame, Robert Blum or Joe
DiazLytham Partners, LLC602-889-9700mbrx@lythampartners.com
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