HOUSTON, Dec. 29, 2020 /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 and viruses, today announced that
the US Food and Drug Administration (FDA) has granted Orphan Drug
Designation (ODD) to Annamycin for treatment of soft tissue
sarcomas.
Moleculin recently announced that the FDA had allowed its
request for Investigational New Drug (IND) status for Annamycin,
allowing Moleculin to begin a Phase 1B/2 clinical trial in the US for patients with
soft tissue sarcoma (STS) that has metastasized to the lungs after
first-line therapy for their disease. The rationale for this
clinical trial includes recent animal data, including data
presented at the American Association of Cancer Research (AACR)
Annual Meeting held June
22nd- 24th, 2020, and data from an
independent laboratory announced on October
21, 2020, which demonstrated that Annamycin is capable of
reaching 6 to 34-fold higher levels of accumulation in the lungs
than that of doxorubicin, the primary first-line chemotherapy for
STS. Additionally, clinical data show no cardiotoxicity
associated with the use of Annamycin, as well as the ability to
avoid multidrug resistance mechanisms, both of which are often
treatment-limiting effects of anthracyclines (which includes
doxorubicin) in this setting. Taken together, these factors
suggest that Annamycin could represent an important treatment to
help address a significant unmet need in patients with STS lung
metastases.
"This is now the second Orphan Drug designation for Annamycin,
as Annamycin previously received ODD for the treatment of relapsed
or refractory acute myeloid leukemia," commented Walter Klemp, Chairman and CEO of Moleculin. "We
believe this continues to show how the breadth of our pipeline
affords us 'multiple shots on goal' and therefore multiple
opportunities to create shareholder value."
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 a broad portfolio of oncology
drug candidates for the treatment of highly resistant tumors and
viruses. 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 hematologic
malignancies, and WP1220, an analog to WP1066, for the topical
treatment of cutaneous T-cell lymphoma. Moleculin is also engaged
in preclinical development of additional drug candidates, including
other Immune/Transcription Modulators, as well as WP1122 and
related 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 Moleculin to receive
the benefits of the Orphan Drug designation, some of which require
FDA approval of Annamycin for the Orphan Drug indication, and the
ability of Annamycin to demonstrate safety and efficacy in
patients. Although Moleculin 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
James Salierno
/ Carol Ruth
The Ruth Group
973-255-8361 / 917-859-0214
jsalierno@theruthgroup.com
cruth@theruthgroup.com
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SOURCE Moleculin Biotech, Inc.