HOUSTON, July 18, 2019 /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, today announced
additional positive interim safety and efficacy data from its
ongoing open label, single arm Phase 1/2 study of Annamycin in
Poland. Three patients were
treated at dose level of 150 mg/m2 with no drug-related
adverse events, including no signs of cardiotoxicity. The results
for all 3 patients were reviewed by the Drug Safety Review
Committee, which determined that the trial could progress to the
next higher dose level of 180 mg/m2. To date in
Poland, one patient experienced
grade 2 mucositis (which resolved to grade 1 within 2 days) and no
other adverse events related to Annamycin have been reported. One
patient has completed treatment in the 120 mg/m2
(second) cohort in the Company's parallel US clinical trial (the US
trial started at a lower initial dose of 100 mg/m2).
"Recruitment in Poland
continues to move rapidly," commented Walter Klemp, Moleculin's Chairman and CEO.
"And, moving beyond the 150 mg/m2 dosing level is quite
significant, as the prior developer of Annamycin was unable to dose
beyond this level. We remain optimistic that new methods for
reducing the onset of mucositis (the dose limiting toxicity for
Annamycin in prior clinical trials) will allow us to safely
increase dosing to 180 mg/m2 or potentially even
higher."
Mr. Klemp continued: "It's also important to remind people that
one of the advantages we believe Annamycin will offer is a lack of
cardiotoxicity. We continue to see no evidence of cardiotoxicity in
any of the patients treated thus far. We intend to advance the
clinical study of Annamycin with the goal of ultimately
demonstrating the drug's safety and effectiveness to support
regulatory approval in both the US and European Union."
Study Design
The Company is studying Annamycin in both the US and
Poland in open label, single arm
clinical trials to assess the safety and efficacy of Annamycin for
the treatment of adults with relapsed or refractory acute myeloid
leukemia. Both the US and Polish trials have the same study design,
providing for a Phase 1 intended to establish a "Recommended Phase
2 Dose," ("RP2D") with cohorts of 3 patients each where the first
cohort starts at a low beginning dose and each successive cohort
receives the next higher dose level until "dose limiting
toxicities" prevent further increases. In the case of cohort
1 in the US, one patient did not complete the evaluation protocol,
so a fourth patient was added to complete that cohort.
A key difference in the US is that the starting dose was 100
mg/m2, whereas, in Poland, the starting dose was 120
mg/m2. Having completed the first cohort in the US, the
Company is seeking patients for the second cohort at a dose level
of 120 mg/m2 and 1 of the 3 patients required to fill
the cohort has now been treated. Now that 3 patients have
completed the safety evaluation period of the second cohort in
Poland, the third cohort will
begin there at a dose level of 180 mg/m2. Once the
Company establishes an RP2D, the intent is for each trial to
advance to a Phase 2 arm planned to assess the safety and efficacy
of Annamycin in 21 additional patients.
The US trial also differs from the Polish trial in that the FDA
would like to review safety data relating to cardiotoxicity from
patients treated prior to advancing beyond 120 mg/m2.
The Company believes that the additional patient safety data gained
from the Polish trial will assist in the FDA's review of cardiac
safety.
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. 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 additional
Immune/Transcription Modulators, as well as 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 the Company to
successfully recruit patients to complete its clinical trials and
the ability of Annamycin to show safety and efficacy in patients.
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. The
Company cautions investors not to place undue reliance on the
interim results announced today.
Contacts
Joe Dorame,
Robert Blum or Joe Diaz
Lytham Partners, LLC
602-889-9700
mbrx@lythampartners.com
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SOURCE Moleculin Biotech, Inc.