HOUSTON, Sept. 9, 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 it successfully completed a pre-IND
(Investigational New Drug) meeting with the U.S. Food and Drug
Administration (FDA) regarding the development plan for Annamycin,
including the clinical study design and dosing strategy for the
initial phase 1b/2 protocol for soft
tissue sarcomas with lung metastases.
Moleculin submitted a proposed clinical protocol for FDA review
entitled, "Phase 1b/2 Study of
Liposomal Annamycin (Annamycin) in Subjects with Previously Treated
Soft-Tissue Sarcomas with Pulmonary Metastases." The proposed study
is an open-label, multicenter, single-arm, dose escalation and
expansion study to evaluate single-agent Annamycin in up to 55
patients with soft tissue sarcoma (STS) with lung metastases for
whom chemotherapy is considered appropriate. The primary objectives
of the dose escalation phase are to evaluate the safety of
Annamycin and identify the maximum tolerated dose (MTD) or the
recommended Phase 2 dose (RP2D).
In summary, the FDA, among other items:
- did not object to the proposed clinical study design while
providing guidance on additional assessments
- agreed the proposed dose escalation schedule appeared
reasonable
- commented regarding the consideration for including adolescents
in oncology clinical trials
- stated that a repeat dose toxicology study of 3 months is
required before initiating a registration study
- recommended an EOP1 meeting after completion of the RP2D.
"We are pleased to complete the pre-IND meeting with the FDA,
and will move forward with our plans to file the IND by the end of
2020 and initiate a Phase 1b/2 trial
of Annamycin for the treatment of soft tissue sarcomas metastasized
to the lungs," said Wally Klemp,
Chief Executive Officer of Moleculin. "We appreciate the FDA's
guidance as we endeavor to find a cure for certain cancers
metastasized to the lungs."
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, being studied for brain tumors, pancreatic cancer and
hematologic malignancies; and WP1220, an analog to WP1066, being
studied for the topical treatment of cutaneous T-cell lymphoma.
Moleculin is also engaged in preclinical development of additional
drug candidates, including additional Immune/Transcription
Modulators, as well as compounds capable of
Metabolism/Glycosylation Inhibition, such as WP1122. Moleculin has
the exclusive worldwide rights (subject to certain territories for
which it has issued sublicenses) to all of the above
technologies.
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 Company's ability to
obtain an IND for Annamycin and the ability of Annamycin to be
shown safe and effective for the treatment of STS with lung
metastases. 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
646-536-7028 / 7000
jsalierno@theruthgroup.com
cruth@theruthgroup.com
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SOURCE Moleculin Biotech, Inc.