HOUSTON, Dec. 7, 2022
/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 granted Fast Track designation
of WP1122 for the treatment of Glioblastoma Multiforme ("GBM"). The
FDA's Fast Track designation is intended to potentially facilitate
the development and expedite the review of novel therapies to treat
serious conditions for which there is unmet medical need. With the
Fast Track designation, Moleculin is potentially eligible for more
frequent regulatory meetings and communications with the FDA.
"We believe receiving Fast Track designation validates the
serious unmet medical need for the treatment of GBM, the most
aggressive form of malignant primary brain cancer," commented
Walter Klemp, Chairman and Chief
Executive Officer of Moleculin. "We believe that based on the
promising animal model data that supports GBM as one of many
potential indications, the clearance of our IND for WP1122 in GBM,
and Orphan Drug Designation previously received from the FDA,
WP1122 is well-positioned to be a potential treatment option for
this devastating disease."
GBM is the most aggressive malignant primary brain tumor and
remains as an incurable tumor with a median survival of only 15
months.1 It is the most common malignant primary brain
tumor making up 54% of all gliomas and 16% of all primary brain
tumors,2 and despite advancements, survival rates for
patients with GBM have shown no notable improvement in population
statistics in the last three decades.3 The average
annual age-adjusted incidence rate of GBM is 3.19 per 100,000
persons in the United
States.4
WP1122 was developed as a 2-DG prodrug to provide a more
favorable pharmacological profile and was found to have greater
potency than 2-DG alone in preclinical models where tumor cells
require higher glycolytic activity than normal cells. Although
activity in animals does not necessarily translate to humans,
preclinical studies in mice transplanted with human brain tumors
showed that WP1122 outperformed the standard of care, temozolomide,
and performed even better in combination with temozolomide.
In September of 2022, Moleculin was granted Orphan Drug
Designation of WP1122 for the treatment of GBM from the FDA.
Additionally, based on preclinical data indicating the potential
for WP1122 as a treatment for GBM, Moleculin received FDA clearance
of its Investigational New Drug application to initiate a Phase 1
open label, single arm, dose escalation study of the safety,
pharmacokinetics and efficacy of oral WP1122 in adult patients with
GBM. The Company is currently evaluating opportunities for
collaboration in clinical development.
About Moleculin Biotech,
Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical
company focused on the development of a broad portfolio of drug
candidates for the treatment of highly resistant tumors and
viruses. The Company's lead program, Annamycin is a next-generation
anthracycline designed to avoid multidrug resistance mechanisms
with little to no cardiotoxicity. Annamycin is currently in
development for the treatment of relapsed or refractory acute
myeloid leukemia (AML) and soft tissue sarcoma (STS) lung
metastases.
Additionally, the Company is developing 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 and
other cancers, and WP1220, an analog to WP1066, for the topical
treatment of cutaneous T-cell lymphoma. Moleculin is also engaged
in the development of a portfolio of antimetabolites, including
WP1122 for the potential treatment of COVID-19 and other viruses,
as well as cancer indications including brain tumors, pancreatic
and other cancers.
For more information about the Company, please visit
www.moleculin.com and connect on Twitter, LinkedIn and
Facebook.
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
establish a suitable collaboration for the development of WP1122
for the treatment of brain tumors, the ability for WP1122 to be
shown to be effective in a human clinical trial for brain tumors,
and the ability for WP1122 to reviewed and approved by the
FDA. 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.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
MBRX@jtcir.com
1: Koshy M, Villano JL, Dolecek TA, Howard A, Mahmood U, Chmura
SJ, et al. Improved survival time trends of glioblastoma using the
SEER 17 population-based registries. J Neuro Oncol.
2012;107(1):207-12
2: Ostrom QT, Gittleman H, Farah P, Ondracek A, Chen Y, Wolinsky Y,
et al. CBTRUS statistical report: Primary brain and central nervous
system tumors diagnosed in the United
States in 2006-2010. Neuro Oncol. 2013;15 Suppl:2ii-56.
3: De Vleeschouwer S, editor. Brisbane (AU): Codon Publications; 2017 Sep
27.
4: Thakkar J, Dolecek TA, Horbinski C, Ostrom QT, Lightner DD,
Barnholtz-Sloan JS, et al. Epidemiologic and molecular prognostic
review of glioblastoma. Cancer Epidemiol. Biomarkers Rev.
2014;23(10):1985-96.
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SOURCE Moleculin Biotech, Inc.