HOUSTON, July 13, 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 it has received approval from the Bioethics
Committee of the Medical University of Karol Marcinkiewicz in Poznań (Ethics Committee)
as well as an allowance from the Polish Department of Registration
of Medicinal Products (URPL) for a protocol amendment for its Phase
1/2 evaluating Annamycin for the treatment of subjects with acute
myeloid leukemia (AML) that is refractory to or relapsed after
induction therapy.
Annamycin is the Company's next-generation anthracycline that
has demonstrated a lack of cardiotoxicity in recently conducted
human clinical trials for the treatment of AML. Additionally,
Annamycin has been shown in animal models to accumulate in the
lungs at up to 30-fold the level of doxorubicin. The Company
believes that the use of Annamycin may not face the same usage
limitations imposed on doxorubicin. Annamycin is currently in
development for the treatment of AML and STS lung
metastases.
"Based on the preliminary data seen demonstrating clinical
benefit for patients receiving a full course of treatment in the
240 mg/m2 cohort and the recommendation from our medical
advisors on the dose limiting toxicity criteria, we are pleased to
have Ethics Committee approval and the allowance from the URPL to
amend the protocol for future patients. This amendment will allow
us to continue dose escalation in the Phase 1 portion of the trial
and establish the maximum tolerated dose as we work toward the
recommended dose for the Phase 2 portion of the study. Our team is
committed to advancing this important clinical program forward and
to potentially address the limitations with current treatment
options for AML patients," commented Walter
Klemp, Chairman and CEO of Moleculin.
The Phase 1/2 AML trial in Poland remains ongoing and is currently dosing
patients at 240 mg/m2. Under the previous protocol
transient elevated liver enzymes (AST and ALT) observed in two
patients were considered a dose limiting toxicity (DLT), which
investigators believe would inappropriately limit the potential for
continued dose escalation. The amendment to the Annamycin clinical
trial protocol allows for a change in the DLT criteria as it
relates to transient grade 3 elevations and allows dosing of three
additional patients in the 240 mg/m2 cohort. If no DLT
(as defined by the new criteria) is experienced with these next
three patients, the Company plans to escalate dosing in new cohorts
by 30 mg/m2 instead of the 60 mg/m2
previously planned, and with a de-escalation of 15 mg/m2
at the DLT dose if future patients experience a DLT.
The results from the Phase 1 portion of the Company's U.S. Phase
1/2 clinical trial of Annamycin for the treatment of AML met its
primary endpoint and demonstrated a clean safety profile with no
evidence of cardiotoxicity when delivered to patients at or below
the lifetime maximum anthracycline dose established by the FDA. To
date, an independent expert assessment of the absence of
cardiotoxicity in the first 19 patients treated with Annamycin in
both the Company's U.S. and European Phase 1 clinical trials in
which an independent expert concluded that he "does not see
evidence of cardiotoxicity."
Moleculin Biotech expects to continue reporting cohort topline
results from the ongoing Phase 1/2 study for treatment of AML and
to report the study's topline results in the second half of 2022.
Annamycin has been granted Fast Track Status and Orphan Drug
Designation from the U.S. Food and Drug Administration for the
treatment of AML.
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 be noncardiotoxic and to avoid multidrug
resistance mechanisms. In addition, Annamycin has been shown in
animal models to reach higher concentration levels than doxorubicin
(a leading anthracycline) in certain key organs, such as the lungs,
liver and pancreas considered to be difficult-to-reach "sanctuary
sites" for tumors. 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 ability of Annamycin to
demonstrate safety and efficacy in patients, the ability of
clinical trials to begin recruiting patients on a timely basis, the
timing of the disclosure of interim data in the second half of
2022, 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.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
MBRX@jtcir.com
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SOURCE Moleculin Biotech, Inc.