HOUSTON, March 30, 2021 /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 U.S. Food and Drug Administration ("FDA")
has approved its request for Fast Track Designation for its drug,
Annamycin, for the treatment of soft tissue sarcoma (STS) lung
metastases.
"We are pleased to receive our second Fast Track Designation
from the FDA for Annamycin. We now have potential pathways for
accelerated approval in two indications, STS lung metastases, and
the treatment of relapsed or refractory acute myeloid leukemia,"
commented Walter Klemp, Moleculin's
Chairman and CEO. "Not only does this make us eligible for
accelerated approval and priority review for our NDA submission,
but it serves as an important reminder of the unmet need in STS
lung metastases. We are now focused on initiating our internally
funded clinical trial in the US, possibly prior to mid-year. In
addition, we recently announced a $1.5
million grant awarded in Poland for an investigator initiated clinical
trial there for this indication which should start later this
year."
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
Soft tissue sarcomas are the most common form of sarcoma,
accounting for an estimated 130,000 incident cases per year
worldwide. While many sarcomas can be addressed through surgical
removal, it is estimated that as many 20% to 50% of STS sarcomas
will eventually metastasize to the lungs, where treatment can
become more challenging.
Once metastasized to the lungs, if tumors cannot be surgically
removed, the primary chemotherapy regimen is the anthracycline
doxorubicin (also known as Adriamycin). While 10% to 30% of
patients with sarcoma lung metastases may initially respond to
doxorubicin, most will relapse leaving the majority of these
patients without an alternative chemotherapy. Treatment options are
further limited because of the inherent cardiotoxicity of currently
approved anthracyclines, including doxorubicin, which limits the
amount of anthracycline that can be given to patients.
Annamycin is a "next generation" anthracycline that has recently
been shown in animal models to accumulate in the lungs at up to
30-fold the level of doxorubicin. Importantly, Annamycin has also
demonstrated a lack of cardiotoxicity in recently conducted human
clinical trials for the treatment of acute myeloid leukemia, so we
believe that the use of Annamycin may not face the same usage
limitations imposed on doxorubicin.
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 Annamycin to
demonstrate safety and efficacy in patients, the ability of
Moleculin to commence a clinical trial in the United States prior to mid-year, the
ability of the investigator initiated clinical trial in
Europe for STS to commence later
this year, the ability of clinical trials to begin recruiting
patients on a timely basis, and whether Annamycin will receive New
Drug Approval. 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 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.