Galectin Therapeutics to Host Webcast to Discuss Findings From Cohort 2 of Phase 1 Clinical Trial of GR-MD-02 in Fatty Liver ...
25 July 2014 - 10:00PM
Galectin Therapeutics (Nasdaq:GALT), the leading developer of
therapeutics that target galectin proteins to treat fibrosis and
cancer, announced the Company will hold a webcast on Tuesday, July
29, 2014 at 8:30 a.m. Eastern Daylight Time to discuss the findings
from cohort 2 of a Phase 1 clinical trial evaluating its galectin
inhibitor GR-MD-02 in fatty liver disease (NASH) with advanced
fibrosis.
Registration and access to the live webcast can be found at the
following link:
http://w.on24.com/r.htm?e=824339&s=1&k=03EDE683D3FB138088B03D9226655B4B
Audio only can be accessed using the following call-in number:
(866) 219-3563, conference ID: 74783858. Peter G. Traber, M.D.,
Chief Executive Officer, President and Chief Medical Officer of
Galectin Therapeutics Inc., will present the findings of cohort 2.
A corresponding presentation will be posted on the Company website
(www.galectintherapeutics.com) prior to the presentation.
The first-in-man study, which enrolled eight patients in the
second cohort, is evaluating the safety, tolerability, and
exploratory biomarkers for efficacy for single and multiple doses
of galectin-inhibiting drug GR-MD-02 when administered to patients
with fatty liver disease (NASH) with advanced fibrosis. Patients in
cohort 2 were dosed at 4 mg/kg, which is double the dose given in
cohort 1. The trial used FibroScan® to gain experience in the
potential use of this device for future Phase 2 studies. FibroScan®
is approved by the U.S. Food and Drug Administration for
noninvasive measurement of shear wave speed at 50 Hz in the liver
and may be used as an aid to clinical management of patients with
liver disease.
The Phase 1 multi-center, blinded (to healthcare providers and
patients) clinical trial is being conducted in patients with NASH
with advanced fibrosis (Brunt Stage 3) who receive four doses of
GR‑MD‑02 over a 42‑day period. Each of the three planned
cohorts consists of eight patients, six randomized to receive
active drug and two randomized to receive placebo. Trial design
details can be found at
http://clinicaltrials.gov/ct2/show/NCT01899859?term=gt-020&rank=1.
About Fatty Liver Disease with Advanced
Fibrosis
Non-alcoholic steatohepatitis (NASH), also known as fatty liver
disease, has become a common disease of the liver with the rise in
obesity rates, estimated to affect nine to 15 million people,
including children, in the U.S. Fatty liver disease is
characterized by the presence of fat in the liver along with
inflammation and damage in people who drink little or no alcohol.
Over time, patients with fatty liver disease can develop fibrosis,
or scarring of the liver, and it is estimated that as many as three
million individuals will develop cirrhosis, a severe liver disease
where liver transplantation is the only current treatment
available. Approximately 6,300 liver transplants are done on an
annual basis in the U.S. There are no drug therapies approved for
the treatment of liver fibrosis.
About Galectin Therapeutics
Galectin Therapeutics (Nasdaq:GALT) 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, key mediators of biologic function. We are
leveraging extensive scientific and development expertise as well
as established relationships with external sources to achieve cost
effective and efficient development. We are pursuing a clear
development pathway to clinical enhancement and commercialization
for our lead compounds in liver fibrosis and cancer. Additional
information is available at www.galectintherapeutics.com.
Forward Looking Statements
This press release contains, in addition to historical
information, 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 our current expectations and are subject to factors
and uncertainties which could cause actual results to differ
materially from those described in the statements. These statements
include those regarding the clinical trial, our drug development
program, and estimates regarding individuals that may develop
cirrhosis. Factors that could cause our actual performance to
differ materially from those discussed in the forward-looking
statements include, among others, that we may not be successful in
developing effective treatments and/or obtaining the requisite
approvals for the use of GR-MD-02 or any of our other drugs in
development. Our 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. We may have
difficulty enrolling new patients, which could impact timing and
costs. Results from the first and second cohort of Phase 1 are not
necessarily indicative of future results in the clinical trial.
Plans regarding development, approval and marketing of any of our
drugs are subject to change at any time based on the changing needs
of our company as determined by management and regulatory agencies.
Regardless of the results of any of our development programs, we
may be unsuccessful in developing partnerships with other companies
that would allow us to further develop and/or fund any studies or
trials. To date, we have incurred operating losses since our
inception, and our ability to successfully develop and market drugs
may be impacted by our ability to manage costs and finance our
continuing operations. For a discussion of additional factors
impacting our business, see our Annual Report on Form 10-K for the
year ended December 31, 2013, and our subsequent filings with the
SEC. You should not place undue reliance on forward-looking
statements. Although subsequent events may cause our views to
change, we disclaim any obligation to update forward-looking
statements.
CONTACT: Galectin Therapeutics Inc.
Peter G. Traber, MD, 678-620-3186
President, CEO, & CMO
ir@galectintherapeutics.com
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