Galectin Therapeutics Begins Phase 2a Psoriasis Study With GR-MD-02
September 24 2015 - 7:00AM
Galectin Therapeutics Inc. (NASDAQ:GALT), the
leading developer of therapeutics that target galectin proteins to
treat fibrosis and cancer, announces the start of a 10-patient
pilot study with GR-MD-02 in patients with moderate-to-severe
plaque psoriasis.
The genesis of this study is the apparent remission of a patient
with severe psoriasis who participated in the Company's Phase 1
study cohort of 4 mg/kg of GR-MD-02 for the treatment of
non-alcoholic steatohepatitis (NASH). That patient received her
fourth infusion of GR-MD-02 in May 2014, and her psoriasis remained
in complete remission for 17 months, with slight scaling becoming
evident on her elbows just this month.
"We are excited to begin this study at the Brooke Army Medical
Center in San Antonio, Texas," said Peter G. Traber, M.D.,
Galectin's president, chief executive officer and chief medical
officer. "We know from the scientific literature that galectin-3 is
at higher levels in the skin of psoriasis patients, and that
GR-MD-02 inhibits galectin-3. It would follow that GR-MD-02 could
affect this disease. We are hopeful that patients with
moderate-to-severe plaque psoriasis will show a clearing of their
disease without the negative side effects associated with many of
the currently available therapies. In addition, a successful pilot
study would add to our robust therapeutic pipeline for this
compound."
Psoriasis, which manifests most often as plaque psoriasis, is a
chronic, relapsing, inflammatory skin disorder. Although plaque
psoriasis is rarely life threatening, it often is intractable to
treatment. According to the International Federation of Psoriasis
Associations, about 3% of the world's population has some form of
psoriasis. In the U.S. there are about 150,000 new cases every
year, and psoriasis affects about 2% of the population, according
to the Cleveland Clinic.
About the Psoriasis Study
This study is a Phase 2a open-label trial in patients with
moderate-to-severe plaque psoriasis in which 10 psoriasis patients
with ≥ 10% of their skin affected and a PASI (psoriasis activity
and severity index) of ≥ 12 points will be treated with 8 mg/kg of
GR-MD-02 every other week for a total of seven infusions. The
primary endpoint will be the PASI-75, or a 75% improvement in the
severity of the disease 30 days following the final infusion. More
information on the trial can be found in a CEO Perspective
published today, which can be found here.
About GR-MD-02
GR-MD-02 is a complex carbohydrate drug that targets galectin-3,
a critical protein in the pathogenesis of fatty liver disease and
fibrosis. Galectin-3 plays a major role in diseases that involve
scaring of organs including fibrotic disorders of the liver, lung,
kidney, heart and vascular system. The drug binds to galectin
proteins and disrupts their function. Preclinical data in animals
have shown that GR-MD-02 has robust treatment effects in reversing
liver fibrosis and cirrhosis.
About Galectin Therapeutics
Galectin Therapeutics is developing promising carbohydrate-based
therapies for the treatment of fibrotic liver disease and cancer
based on the Company's unique understanding of galectin proteins,
which are key mediators of biologic function. Galectin seeks to
leverage extensive scientific and development expertise as well as
established relationships with external sources to achieve
cost-effective and efficient development. The Company is pursuing a
development pathway to clinical enhancement and commercialization
for its lead compounds in liver fibrosis and cancer. Additional
information is available at www.galectintherapeutics.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These statements relate to future events or future financial
performance, and use words such as "may," "estimate," "could,"
"expect" and others. They are based on management's current
expectations and are subject to factors and uncertainties that
could cause actual results to differ materially from those
described in the statements. These statements include those
regarding the hope that Galectin's development program for GR-MD-02
will lead to an additional therapy for the treatment of psoriasis
as well as the first therapy for the treatment of fatty liver
disease with cirrhosis. Factors that could cause actual performance
to differ materially from those discussed in the forward-looking
statements include, among others, that Galectin may not be
successful in developing effective treatments and/or obtaining the
requisite approvals for the use of GR-MD-02 or any of its other
drugs in development for the treatment of psoriasis, fatty liver
disease with cirrhosis or other diseases. The Company's current
clinical trials and any future clinical studies may not produce
positive results in a timely fashion, if at all, and could prove
time consuming and costly. Plans regarding development, approval
and marketing of any of Galectin's drugs are subject to change at
any time based on the changing needs of the Company as determined
by management and regulatory agencies. There are a number of drugs
available for the treatment of psoriasis, which may affect both the
approval of GR-MD-02 for the treatment of psoriasis and the
subsequent marketing of it. Regardless of the results of any
of its development programs, Galectin may be unsuccessful in
developing partnerships with other companies or raising additional
capital that would allow it to further develop and/or fund any
studies or trials. Galectin has incurred operating losses
since inception, and its ability to successfully develop and market
drugs may be impacted by its ability to manage costs and finance
continuing operations. For a discussion of additional factors
impacting Galectin's business, see the Company's Annual Report on
Form 10-K for the year ended December 31, 2014, and subsequent
filings with the SEC. You should not place undue reliance on
forward-looking statements. Although subsequent events may cause
its views to change, management disclaims any obligation to update
forward-looking statements.
Galectin Therapeutics and its associated logo is a registered
trademark of Galectin Therapeutics Inc.
CONTACT: Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com
LHA
Kim Golodetz
(212) 838-3777
kgolodetz@lhai.com
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