HOUSTON, April 18, 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, today announced
that the U.S. Food and Drug Administration ("FDA") has approved its
request for Fast Track Designation for its drug, Annamycin, for the
treatment of relapsed or refractory acute myeloid leukemia
("AML").
"We are thrilled that Annamycin has been granted Fast Track
Designation," commented Walter
Klemp, Moleculin's Chairman and CEO. "Not only does this
make us eligible for accelerated approval and priority review, but
it serves as an important validation of the significant unmet need
we are trying to address. Currently, Annamycin is in separate Phase
I/II trials in the U.S. and Europe
for the treatment of AML and the Company has recently announced
positive interim top line data."
A drug that receives Fast Track designation is
eligible for some or all of the following:
- More frequent meetings with FDA to discuss the drug's
development plan and ensure collection of appropriate data needed
to support drug approval
- More frequent written communication from FDA about such things
as the design of the proposed clinical trials and use of
biomarkers
- Eligibility for Accelerated Approval and Priority Review, if
relevant criteria are met
- Rolling Review, which means that a drug company can
submit completed sections of its Biologic License Application (BLA)
or New Drug Application (NDA) for review by FDA, rather than
waiting until every section of the NDA is completed before the
entire application can be reviewed. BLA or NDA review usually does
not begin until the drug company has submitted the entire
application to the FDA
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 AML, and WP1220, an analog to
WP1066, for the topical treatment of cutaneous T-cell lymphoma.
Moleculin Biotech 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 Annamycin to
benefit from an accelerated approval pathway or ultimate approval
from the FDA for Annamycin. 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.
Contacts
Joe Dorame
Lytham Partners, LLC
602-889-9700
mbrx@lythampartners.com
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SOURCE Moleculin Biotech, Inc.