Galectin Therapeutics Discusses Corporate Transformation, Progress of NAVIGATE Trial and Outlines Strategy for Potential Phase 2 Cancer Immunotherapy Trial at Annual Meeting
December 13 2021 - 8:00AM
Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer
of therapeutics that target galectins, provided an update on its
strategy and clinical trial progress at its 2021 Annual Meeting,
held virtually on December 3, and reported that shareholders
approved all proposals, including the reelection of its Board of
Directors.
“Compared to a year ago, Galectin Therapeutics has been
transformed into a new company,” said Joel Lewis, Chief Executive
Officer and President of Galectin Therapeutics. “The addition of
highly-skilled and experienced professionals to our management team
and advisors, most prominently Dr. Ben Carson, continued progress
with our global NASH cirrhosis registration trial, and the Board’s
authorization to evaluate the initiation of a company-sponsored
Phase 2 oncology program, enhances Galectin Therapeutics’ position
as the leader in galectin 3 inhibition.”
During the Annual Meeting, Mr. Lewis and Dr. Pol Boudes, Chief
Medical Officer of Galectin Therapeutics, made a presentation
highlighting the following:
Update on Oncology Program
- Recently engaged three noted physicians – Dr. Chetan
Bettegowda, from Johns Hopkins, and Dr. Nishant Agrawal and Dr. Ari
Rosenberg, both from University of Chicago Medical Center – as
consultants to help define the path forward in oncology.
- Strategic review with Drs. Bettegowda, Argawal and Rosenberg
identified Head and Neck cancer patients as the population in
highest need of new treatment, and a potential protocol for a Phase
2 trial of belapectin in combination therapy in this indication is
under development.
Update on NAVIGATE Study in NASH Cirrhosis
- Despite the challenges presented by COVID-19, particularly
outside the U.S., the NAVIGATE Phase 2b/3 trial in NASH cirrhosis
has been initiated in all countries originally selected for
participation.
- To balance the risks of the pandemic, additional countries are
on the verge of being initiated and will soon contribute to global
recruitment effort.
General Corporate Update
- In 2021, retained Dr. Ben Carson as a strategic consultant and
hired four executives in key leadership positions. Expanded team
possesses large pharma experience and operational expertise in
virtually every aspect of drug development, including global
registrations.
“Based on the feedback we receive from our investigators, there
is no question in our mind that the NAVIGATE study is considered an
important milestone by the medical community,” concluded Pol
Boudes, M.D., Chief Medical Officer of Galectin Therapeutics.
“NAVIGATE should further trigger the interest of clinical
researchers for cirrhosis in general, and NASH cirrhosis in
particular, something that is also part of our mission at Galectin
Therapeutics.”
A replay of the Annual Meeting can be accessed here:
https://east.virtualshareholdermeeting.com/vsm/web?pvskey=GALT2021
A transcript of the meeting is available here:
https://investor.galectintherapeutics.com/node/16661/html
About Belapectin
Belapectin is a complex carbohydrate drug that targets
galectin-3, a critical protein in the pathogenesis of NASH 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. Belapectin binds to
galectin-3 and disrupts its function. Preclinical data in animals
have shown that belapectin has robust treatment effects in
reversing liver fibrosis and cirrhosis. A Phase 2 study showed
belapectin may prevent the development of esophageal varices in
NASH cirrhosis, and these results provide the basis for the conduct
of the NAVIGATE trial. The NAVIGATE trial (www.NAVIGATEnash.com),
titled “A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized,
Placebo-controlled Multicenter, International Study Evaluating the
Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of
Esophageal Varices in NASH Cirrhosis,” began enrolling patients in
June 2020, and is posted on www.clinicaltrials.gov (NCT04365868).
Galectin-3 has a significant role in cancer, and the Company has
supported a Phase 1b study in combined immunotherapy of belapectin
and KEYTRUDA in advanced melanoma and in head and neck cancer. This
trial provided a strong rationale for moving forward into a
Company-sponsored Phase 2 development program, which the company is
exploring.
About Galectin Therapeutics
Galectin Therapeutics is dedicated to developing novel therapies
to improve the lives of patients with chronic liver disease and
cancer. Galectin’s lead drug belapectin (formerly known as
GR-MD-02) is a carbohydrate-based drug that inhibits the galectin-3
protein which is directly involved in multiple inflammatory,
fibrotic, and malignant diseases, for which it has Fast Track
designation by the U.S. Food and Drug Administration. 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 one of the largest drug
development opportunities available today. Additional development
programs are in treatment of combination immunotherapy for advanced
melanoma and other malignancies. Advancement of these additional
clinical programs is largely dependent on finding a suitable
partner. 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.
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
belapectin 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
and in other therapeutic indications. Factors that could cause
actual performance to differ materially from those discussed in the
forward-looking statements include, among others, that trial
endpoints required by the FDA may not be achieved; Galectin may not
be successful in developing effective treatments and/or obtaining
the requisite approvals for the use of belapectin or any of its
other drugs in development; the Company may not be successful in
scaling up manufacturing and meeting requirements related to
chemistry, manufacturing and control matters; the Company’s current
clinical trial and any future clinical studies as modified to meet
the requirements of the FDA may not produce positive results in a
timely fashion, if at all, and could require larger and longer
trials, which would be 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. Global
factors such as coronavirus may continue to impact NASH patient
populations around the globe and slow trial enrollment and prolong
the duration of the trial and significantly impact associated
costs. 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, 2020, 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.
Company Contact:
Jack Callicutt, Chief Financial Officer(678)
620-3186ir@galectintherapeutics.com
Galectin Therapeutics and its associated logo is a registered
trademark of Galectin Therapeutics Inc. Belapectin is the USAN
assigned name for Galectin Therapeutics’ galectin-3 inhibitor
GR-MD-02.
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