– Ongoing efforts to open additional clinical
sites in Poland and to gain
approval to proceed in other European countries
– First subject treated in Italy expected in the first quarter of
2023
HOUSTON, Dec. 21,
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 it has received approval from the Agenzia Italiana
del Farmaco (AIFA, the Italian Medicines Agency competent
authority) and the Istituto Superiore di Sanità (ISS, the Italian
National Institute of Health) for its Phase 1/2 trial evaluating
Annamycin in combination with Cytarabine (Ara-C) in the treatment
of subjects with AML who are refractory to or relapsed after
induction therapy (MB-106). This adds to the approval the Company
already has in Poland where three
sites are currently open and recruiting subjects. Additionally, the
Company has ongoing efforts to open additional clinical sites in
Poland and Italy and gain approval to proceed in other
European countries for the MB-106 clinical trial to potentially
improve recruitment rates.
"We are pleased to receive authorization to expand our MB-106
trial into Italy. This marks an
important milestone in the global expansion of our AML development
program. Based on the encouraging data seen to date from the
successfully concluded single agent trials, we remain very
optimistic in Annamycin's potential to treat refractory or relapsed
AML in combination with Cytarabine. We are committed to driving
enrollment and our team is working diligently to bring additional
sites online and enroll subjects for the study," commented
Walter Klemp, Chairman and CEO of
Moleculin. He continued, "In Poland we expect the first subject to
be treated in MB-106 to be in the near term."
Annamycin is the Company's next-generation anthracycline that
has been designed to be non-cardiotoxic and has been shown in
animal models to accumulate in the lungs at up to 30-fold the level
of doxorubicin (a commonly prescribed anthracycline), as well as
demonstrating the ability to avoid the multidrug resistance
mechanisms that typically limit the efficacy of doxorubicin and
other currently prescribed anthracyclines. Annamycin is currently
in development for the treatment of relapsed or refractory AML and
STS lung metastases and the Company believes it may have the
potential to treat additional indications.
The Phase 1/2 MB-106 trial is an open label trial that builds on
the safety and dosage data from the two successfully concluded
single agent Annamycin AML Phase 1 trials (MB-104 and MB-105)
conducted in the U.S. and Europe.
Additionally, the preclinical animal data from sponsored research
demonstrated Annamycin in combination with Cytarabine had a 68%
improvement in the median overall survival (OS) compared to
Annamycin as a single agent and a 241% increase in OS compared to
Cytarabine alone.1 Subject enrollment and screening for
the MB-106 trial is underway and the Company expects to initiate
subject treatment in the near term and the first subject to be
treated in Italy in the first
quarter of 2023.
Annamycin currently has Fast Track Status and Orphan Drug
Designation from the US Food and Drug Administration (FDA) for the
treatment of STS lung metastases and the treatment of relapsed or
refractory AML. For more information about the MB-106 Phase 1/2
trial, visit clinicaltrialsregister.eu and reference EudraCT
2020-005493-10 or clinicaltrials.gov and reference
NCT05319587.
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 timing of the first
patient treated in MB-106, whether the results of Moleculin's
preclinical animal models can be replicated in human trials and
Moleculin's ability to expand its MB-106 clinical trial using
Annamycin in combination with Cytarabine for the treatment of R/R
AML into additional sites in Poland and other countries in Europe to potentially improve recruitment
rates. 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.
1 Zal T, Zielinski R, Grela K, Cardenas-Zuniga
R, Skora S, Fokt I, Zal A, Andreeff M, Gil L Shephard R, Priebe W,
High Efficacy of Liposomal Annamycin (L-ANN) in Combination with
Cytarabine in Syngeneic p53-Null AML Mouse Model, Blood (2020) 136
(Supplement 1): 6-7. https://doi.org/10.1182/blood-2020-143344
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
MBRX@jtcir.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/moleculin-receives-approval-in-italy-to-conduct-phase-12-trial-evaluating-annamycin-in-combination-with-cytarabine-ara-c-for-the-treatment-of-acute-myeloid-leukemia-aml-301707799.html
SOURCE Moleculin Biotech, Inc.