Galectin Therapeutics, Inc. (NASDAQ:GALT), the
leading developer of therapeutics that target galectin proteins,
today announced that the Company has received notice of allowance
for a U.S. Patent for "Method of Enhancing Specific Immunotherapies
in Cancer Treatment." Cancer immunotherapy research conducted by
Dr. William Redmond at the Earle A. Chiles Research Institute at
the Providence Cancer Center in Portland, Oregon was instrumental
in the allowance of this patent. Members of Galectin and Providence
are joint inventors on the patent, and Galectin holds the exclusive
license. The patent’s principal claims cover method of use of
GR-MD-02 as a means to enhance anti-tumor activity and increase
survival effects of combining GR-MD-02 with multiple clinically
relevant types of immune modulators, such as KEYTRUDA®; and for
multiple types of cancer.
This patent provides intellectual property protection for the
ongoing human trial that evaluates the effect of the combination of
GR-MD-02 with approved cancer immunotherapy drugs. Results of the
first cohort of the Phase 1b study of a galectin inhibitor
(GR-MD-02) and pembrolizumab (KEYTRUDA®) in patients with
metastatic melanoma were reported earlier this year, and now
Galectin reports that the second cohort of three patients treated
with 4 mg/kg of GR-MD-02 has been completed, and the third cohort
of 10 patients treated with 8 mg/kg will begin enrollment after the
patients in the second cohort have completed 85 days of protocol,
as per FDA agreement (more information at clinicaltrials.gov).
Additionally, the patent covers the ability of GR-MD-02 to
enhance the effectiveness of immune modulators in a variety of
cancers, including gastrointestinal cancer, pancreatic cancer, bile
duct cancer, sarcoma, myosarcoma, breast cancer, lung cancer, head
and neck cancer, mouth cancer, skin cancer, melanoma, kidney
cancer, urinary tract cancer, prostate cancer, testicular cancer,
ovarian cancer, endometrial cancer, neurological cancer, endocrine
gland cancer, bone cancer, hematological cancers, multiple myeloma,
and myelofibrosis. The patent coverage extends through
2033.
“This patent protects our ability to use GR-MD-02 to enhance the
effectiveness of multiple classes of immune modulators, in the
treatment of a wide range of cancers,” said Peter G. Traber, M.D.,
chief executive officer and chief medical officer of Galectin
Therapeutics. “This patent arose from research conducted by
Dr. Redmond at the Earle A. Chiles Research Institute and
Providence Cancer Center, which is also conducting the clinical
trials under Principal Investigator Dr. Brendan Curti. We
look forward to continuing our relationship in more extensive
trials.”
William L. Redmond, Ph.D., Associate Member, Laboratory of
Cancer Immunotherapy and Director, Immune Monitoring
Laboratory, Earle A. Chiles Research Institute at
the Providence Cancer Center, one of the inventors on the
patent, said, “Based on the effects of GR-MD-02 in animal models of
cancer and the early results of the Phase 1b trial in patients with
advanced melanoma, oral/head and neck cancer (OHN) or non-small
cell lung cancer (NSCLC), we believe continuing the KEYTRUDA and
GR-MD-02 arm of the combination immunotherapy study is
warranted.”
With this patent, the Company now holds 17 granted U.S. patents,
24 foreign granted patents (Japan, E.U., New Zealand, and
Australia). Additionally, the Company has 49 international patent
applications, and 4 U.S. patent applications in process. Many of
the Company’s patents and patent applications cover composition of
matter for complex carbohydrate drugs and methods of use for
reducing toxicity and enhancing chemotherapeutic drugs by
co-administering a polysaccharide with a chemotherapeutic agent or
for use in treatment of fibrosis. Granted patents include
composition of matter, process of manufacture, and various methods
of use. The breadth of coverage for the patent portfolio
includes; various types of organ fibrosis (liver, lung, kidney, and
heart), non-alcoholic steatohepatitis, kidney disease, autoimmune
disorders and cancer, including combination cancer
immunotherapy.
GR-MD-02, a Non-Biological Complex Drug (NBCD), is a proprietary
polysaccharide pharmaceutical preparation that inhibits galectin
proteins. In addition to the Combination Immunotherapy cancer
trials, GR-MD-02 is currently being studied in a Phase 2b clinical
trial in subjects with NASH cirrhosis. Additionally, GR-MD-02 has
been studied and shown encouraging preliminary results in two,
open-label Phase 2a trials in patients with severe skin diseases,
including moderate-to-severe plaque psoriasis and atopic
dermatitis.
About Galectin TherapeuticsGalectin
Therapeutics is developing promising therapies for the treatment of
fibrotic liver disease, skin diseases, 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.
About Robert W. Franz Cancer Research Center, Earle A.
Chiles Research Institute (EACRI), Providence Cancer Center,
Providence Portland Medical CenterProvidence Cancer
Center, a part of Providence Health & Services, offers the
latest in cancer services, including diagnostic, treatment,
prevention, education, support and internationally renowned
research. The Robert W. Franz Cancer Research Center in the Earle
A. Chiles Research Institute is a world-class research facility
located within Providence Cancer Center. The Institute's main area
of investigation is cancer immunotherapy, a specialized field of
study focused on triggering the immune system to fight cancer.
Visit www.chilesresearch.org.
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 the first therapy for the treatment of fatty liver
disease with cirrhosis and those regarding the hope that our lead
compounds will be successful in connection with cancer
immunotherapy. 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; the Company's current clinical trial 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; 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, 2016, 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:
Galectin Therapeutics, Inc.
Jack Callicutt, Chief Financial Officer
678-620-3186
ir@galectintherapeutics.com
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