HOUSTON, April 29, 2019 /PRNewswire/ -- A small
public company with 6 highly promising anti-cancer drugs in the
pipeline is augmenting US clinical trials with trials in
Poland, speeding the process of
patient recruitment and data collection. The company, Moleculin
(NASDAQ: MBRX), recently recruited 3 patients in 6 weeks in
Poland, whereas in the U.S. it
took a full year to build a similar, complete cohort. The company
now has 2 clinical trials with patients enrolled in Poland.
The phase 1/2 clinical trial now underway in Poland for the company's Annamycin compound
has already shown promising results with one trial patient's acute
myeloid leukemia (AML) now in remission, making the patient
eligible for a bone marrow transplant. While significant additional
study is necessary to definitively demonstrate causality, Moleculin
has already begun to identify more patients in Poland for the next cohort of the same trial
and 2 more patients for its WP1220 topical treatment of cutaneous
T-cell lymphoma (CTCL).
"The clock is ticking for many patients suffering from
hard-to-combat cancers," said Walter
Klemp, CEO, Moleculin Inc. "For a smaller pharmaceutical
company with a promising roster of drug candidates for targeting
these highly resistant tumors, speed in launching trials is
critical. We feel lucky to have found a well-established medical
community where access to patients is easier and faster. If the
promising results continue, we look forward to getting our drugs
into the hands of such patients much sooner."
"While the response of a single patient doesn't necessarily
predict the outcome of the trial, this is a great way to begin and
it's consistent with our expectations for Annamycin," Mr. Klemp
continued. "We have seen no evidence of cardiotoxicity in any of
the patients treated thus far and 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
the US and European Union."
The additional patient safety data gained from the Polish trials
may also assist in the FDA's review of cardiac safety which can be
a key factor in regulatory approval.
US Market Recruitment Challenges
Without data from clinical trials, drug development companies
have no way forward. However, recruiting for anti-cancer clinical
trials in the US can be slow. With large pharma companies targeting
the US market with both ground-breaking and "me-too" drugs, there
is significant competition for patients in the United States.
Also, oncology clinical trials are typically conducted in one of
61 major cancer centers in urban areas, making it difficult for
qualified rural patients to participate. Elderly American patients
often decline because they or their families have caregiving and
scheduling demands that make such trials difficult.
Other issues that make trials difficult include insurance and
financial concerns, as insurers often require that clinical trials
be conducted in-network.
To build a larger base of clinical trial patients more quickly,
Moleculin began working with the medical community in Poland, where the company's Founding Scientist
Dr. Waldemar Priebe was born.
Currently a researcher at M.D. Anderson Cancer Center in
Houston, Priebe is extremely
familiar with the Polish medical establishment. As a location for
clinical trials, Poland has a
medical infrastructure and community acceptable to the FDA and
offers many benefits to the small biopharma. These include:
- Highly rated medical infrastructure and medical community
(Poland is ranked seventh in
Europe for clinical trial
participation, with an annual average of about 40,000 patients in
clinical trials. The clinical trial market there was estimated to
be about 200M euros as of 2014.
- With fewer drug developers, there is less competition for
clinical trial patients in Poland.
- A greater number of patients who are "treatment-naïve," meaning
they are less likely to have resistant cells from other medical
treatments.
- The European Medicines Agency is receptive to starting clinical
trials at higher, more therapeutic drug doses.
For the current Moleculin Polish trial, the allowable starting
dose was 120 mg/m2, offering the opportunity to provide
patients with what the Company considers a potentially more
therapeutic dose than the 100 mg/m2 required in the US.
Once 3 patients have completed the safety evaluation period of the
first cohort in Poland, the second
cohort will begin there at a dose level of 150 mg/m2.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc.
is a clinical stage pharmaceutical company focused on the
development of oncology drug candidates, all of which are based on
discoveries made at M.D. Anderson Cancer Center. The Company's
clinical stage drugs are Annamycin, an 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, and WP1066, an immuno-stimulating STAT3 inhibitor targeting
brain tumors, pancreatic cancer and AML. Moleculin Biotech is also
engaged in preclinical development of additional drug candidates,
including additional STAT3 inhibitors and compounds targeting the
metabolism of tumors.
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 WP1066 to show safety
and efficacy in patients. Although Moleculin Biotech 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.
Media Contact:
Erica
Zeidenberg
PR for Moleculin
925 631 0553 office
925 518 8159 mobile
erica@hottomato.net
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SOURCE Moleculin Biotech, Inc.