Galectin Therapeutics Inc. (NASDAQ:GALT), the
leading developer of therapeutics that target galectin proteins,
and Providence Cancer Institute today announced
additional preliminary clinical data from cohort 3 of an
investigator-initiated Phase 1b clinical trial of GR-MD-02 used in
combination with KEYTRUDA® (pembrolizumab) in patients with
metastatic melanoma for which KEYTRUDA is indicated or those
patients whose melanoma progressed during or recently after
KEYTRUDA monotherapy.
The Providence Cancer Institute (Portland, OR) translational
medicine team is conducting this phase 1b clinical trial, initiated
under direction of principal investigator Brendan D. Curti, M.D.,
Director, Providence Melanoma Program. The objectives of this study
were to determine a safe dose of GR-MD-02 used in combination with
KEYTRUDA and to measure the response rate to combined therapy. “We
are very encouraged by the objective response rate and the disease
control rate observed in patients with advanced melanoma. These
response rates were higher than expected with KEYTRUDA alone,” said
Dr. Curti. “An objective response rate of seven out of fourteen
patients (50%) and a disease control rate of nine out of fourteen
patients (64%) with advanced melanoma is very encouraging. The
published objective response rates in randomized studies using
KEYTRUDA in patients with advanced melanoma range from 21% in
patients who have had prior therapy to 39% in patients who had not
received prior systemic therapy. Importantly, the combination was
also very well tolerated, and treatment appears to be associated
with fewer adverse events than expected with KEYTRUDA alone.”
When aggregated with the cohorts previously reported, the data
shows a 50% objective response rate in advanced melanoma with
GR-MD-02 in combination with KEYTRUDA, and a significant decrease
in the frequency of suppressive myeloid-derived suppressor cells
(MDSC) following treatment in the responding patients (on day 85
post-treatment) was observed. The published data on KEYTRUDA alone
have shown an objective response rate of 33% in this patient
population.
Fourteen advanced melanoma patients across three dose cohorts
now have Objective Response Rate (ORR) and Disease Control Rate
(DCR) data. Six patients in cohort 3 (8 mg/kg GR-MD-02) have now
been added to the three patients in cohort 2 (4 mg/kg GR-MD-02) and
the five patients in cohort 1 (2 mg/kg GR-MD-02). Cohorts 1 and 3
each had two patients with an objective response. All three
patients in cohort 2 had an objective response.
Generally, the U.S. Food and Drug Administration has defined
objective response rate as the sum of partial responses plus
complete responses. Disease control rate is the objective responses
plus those with stable disease.
In addition to the fourteen advanced melanoma patients, six
patients with head and neck cancer were enrolled in this phase 1b
trial with a 33% objective response rate and a 67% disease control
rate. Dr. Curti states “the response rates observed overall in
advanced melanoma and head and neck cancer patients were better
than expected with KEYTRUDA alone and are the basis for moving
forward with both tumor types, particularly given the low response
rates of anti-PD-1 monotherapy in head and neck cancer. There is a
significant clinical need for better options for these patients and
our initial objective response rates were encouraging enough to
warrant inclusion of additional patients to help determine whether
we should also pursue these challenging patient populations in a
phase 2 trial. Taken together with the observed favorable safety
and tolerability of the combination, these results provide a
compelling rationale to move forward with this approach.” Given
that all three melanoma patients (100%) were responders at 4 mg/kg
dose, the investigators plan to continue the trial with expansion
of the 4 mg/kg GR-MD-02 and KEYTRUDA cohort to include additional
advanced melanoma patients and additional head and neck cancer
patients.
“In addition to the encouraging clinical responses seen thus
far, we continue to make progress on identifying immunological
biomarkers that correlate with favorable responses,” said William
L. Redmond, Ph.D., Associate Member, Laboratory of Cancer
Immunotherapy, and Director, Immune Monitoring Laboratory at the
Earle A. Chiles Research Institute, a division of Providence Cancer
Institute. “We have observed a significant decrease in the
frequency of suppressive myeloid-derived suppressor cells (MDSC)
following treatment in the responding patients (on day 85
post-treatment). Comprehensive laboratory studies are being
performed to further identify the biological mechanisms associated
with this response.”
“Galectin Therapeutics is very pleased with our continuing
collaboration with Providence Cancer Institute, and we are
encouraged that Dr. Curti and his team are expanding the trial to
include additional patients,” said Harold Shlevin, Ph.D., CEO and
President of Galectin Therapeutics. “The planned expansion of the
size of the 4 mg/kg dose cohort, and inclusion of both advanced
melanoma patients and patients with head and neck cancer, will
permit further evaluation that the use of GR-MD-02 in combination
with KEYTRUDA has a better objective response rate and fewer
adverse events than KEYTRUDA alone. We believe this collaboration
with Providence to be a fruitful approach to helping to determine
the potential of GR-MD-02 in combination immuno-therapy, and it
also leverages our ability to collect additional data related to
the immunological monitoring of these patients before potentially
proceeding to the next phase of development.”
Additional information about this clinical trial may be found
at: www.clinicaltrials.gov/ct2/show/NCT02575404
About GR-MD-02GR-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 scarring of organs
including fibrotic disorders of the liver, lung, kidney, heart and
vascular system. The drug binds to galectin-3 proteins and disrupts
its function. Preclinical data in animals have shown that GR-MD-02
has robust treatment effects in reversing liver fibrosis and
cirrhosis. GR-MD-02 also has robust efficacy in pre-clinical cancer
models in combination with immunotherapy agents.
About Galectin TherapeuticsGalectin
Therapeutics is dedicated to developing novel therapies to
improve the lives of patients with chronic liver and cancer.
Galectin's lead drug (GR-MD-02) is a carbohydrate-based drug that
inhibits the galectin-3 protein that is directly involved in
multiple inflammatory, fibrotic, and malignant diseases. The lead
development program is in non-alcoholic steatohepatitis (NASH) with
cirrhosis, the most advanced form of NASH related fibrosis. This is
the most common liver disease and is believed to be one of the
largest drug development opportunities available today. Additional
exploratory development programs are in combination immunotherapy
for advanced melanoma and other malignancies. Galectin seeks to
leverage extensive scientific and development expertise as well as
established relationships with external sources to achieve
cost-effective and efficient development. Additional information is
available at www.galectintherapeutics.com.
About Earle A. Chiles Research Institute, a division of
Providence Cancer Institute, at the Robert W. Franz Cancer Center,
in Portland, ORProvidence Cancer Institute, a part of
Providence Health & Services, offers the latest in cancer
services, including diagnostic, treatment, prevention, education,
support and internationally-renowned research. The Earle A. Chiles
Research Institute, a division of Providence Cancer Institute, is a
world-class research facility located within the Robert W. Franz
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.
About RECIST CriteriaRECIST is a set of
published rules that define when tumors in cancer patients improve
("respond"), stay the same ("stabilize"), or worsen ("progress")
during treatment. The criteria were published in February 2000 by
an international collaboration including the European Organisation
for Research and Treatment of Cancer (EORTC), National Cancer
Institute of the United States, and the National Cancer Institute
of Canada Clinical Trials Group. Today, the majority of clinical
trials evaluating cancer treatments for objective response in solid
tumors use RECIST. In solid tumors, tumor response measures the
changes in tumor mass, growth (progression) or shrinkage (response)
and it is often assessed using the RECIST criteria (Response
Evaluation Criteria in Solid Tumor). Although it is still the
object of criticism (e.g. the definition of cut-off used to define
the response and the progression), RECIST provides a simplified set
of criteria for evaluating tumors response via an anatomical
approach using a unidimensional measure of tumor burden.
Further information on RECIST criteria is available at:
https://ctep.cancer.gov/protocolDevelopment/docs/recist_guideline.pdf
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 cancer immunotherapy. Factors that
could cause actual performance to differ materially from those
discussed in the forward-looking statements include, among others,
that the current management leadership may not be as effective as
the predecessor management team; for the clinical trials in cancer
immunotherapy, Galectin has relied on the trials undertaken by
Providence, which limits the number of patients included in the
trials; Galectin may be unsuccessful in expanding the scope of the
cancer immunotherapy trials, and the results of expanded trials may
not be positive; Galectin may not be successful in developing
effective treatments and/or obtaining the requisite approvals for
the use of GR-MD-02; manufacturing of drug product now in scale-up
may not be successful or meet regulatory expectations, the
Company’s Phase 3 clinical trial for the treatment of fatty liver
disease, now in the initial planning stages, and any future
clinical studies, including those in connection with cancer
immunotherapy may not proceed and 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, 2017, 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.
KEYTRUDA® is a registered trademark of Merck & Co., Inc.
Investor Contact:Galectin Therapeutics,
Inc.Jack Callicutt, Chief Financial Officer
Media Contact: Gregory FCALeigh Minnier, Vice
President610-228-2108leigh@gregoryfca.com
A photo accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/6ec20cf5-0917-4492-afe8-a399f7836703
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