MODI'IN, Israel, Aug. 3, 2015 /PRNewswire/ -- Exalenz Bioscience
(TASE: EXEN), a leader in developing and marketing non-invasive
medical devices for diagnosing and monitoring a range of
gastrointestinal and liver diseases, today announced a
collaboration with Galectin Therapeutics (Nasdaq: GALT) to use the
BreathID® test to monitor patients in a Phase II study evaluating
GR-MD-02. GR-MD-02 is an investigational treatment for patients
with cirrhosis associated with nonalcoholic steatohepatitis (NASH
Cirrhosis).
The 156 patient, multicenter, randomized, placebo-controlled,
double-blind clinical trial will evaluate the safety and efficacy
of GR-MD-O2 for the treatment of liver fibrosis and portal
hypertension in patients with NASH Cirrhosis. As part of the study,
Exalenz will investigate the clinical utility of BreathID® to
follow up the effect of treatment on patients with NASH Cirrhosis,
compared to standard medical tests including hepatic venous
pressure gradient (HVPG), liver biopsy results, and liver stiffness
testing. Exalenz recently received approval from the U.S.
Food and Drug Administration (FDA) of an investigational device
exemption (IDE) for the trial.
"It has been reported that NASH affects up to 10 percent of the
U.S. population and represents a significant unmet medical need
with no currently approved pharmacological treatment. Currently the
only valid measures for diagnosis and follow up are invasive liver
biopsy and HVPG," said Raffi Werner,
chief executive officer of Exalenz Bioscience. "We are excited to
collaborate with Galectin Therapeutics in this clinical study and
believe that our non-invasive, operator-independent, breath-based
test has the potential to assist clinicians in determining patient
suitability for treatment and to conveniently and cost-effectively
monitor the effect of therapy at the point of care."
During the study, enrolled participants will receive three
breath-based tests: the first will be given during the screening
stage, the second will be given at week 25 of treatment and the
third will be given after the final dose of GR-MD-02. The results
of this study will be used to further evaluate the efficacy of
BreathID® and to optimize the company's proprietary algorithm for
monitoring the progression of NASH Cirrhosis to determine the
clinical effectiveness of Galectin Therapeutics' GR-MD-02 treatment
among enrolled patients. Exalenz Bioscience expects that the
optimized algorithm will continue to be applied to data collected
in its other ongoing studies.
"Early clinical data evaluating GR-MD-02 have been encouraging,
demonstrating that our potential treatment for NASH Cirrhosis is
safe, well-tolerated and achieved the targeted therapeutic dose,"
said Peter G. Traber, M.D.,
Galectin's chief executive officer, president and chief medical
officer. "We are excited to be initiating a larger study in a
broader patient population, and proud to be partnering with Exalenz
Bioscience to further validate how their novel, non-invasive,
breath-based technology can be used to select patients with NASH
Cirrhosis who are candidates for therapy and to follow up the
effect of our drug. The data from the BreathID® will provide
valuable information for clinical stage pharmaceutical companies
actively working on bringing new therapeutic options to
patients."
This study is part of Exalenz's growing clinical pipeline of
investigational diagnostic applications utilizing BreathID® to
diagnose for serious liver diseases. In addition to two trials
related to NASH, the company has ongoing clinical trials for
detection of primary liver cancer (Hepatocellular Carcinoma - HCC)
and diagnosis of Clinically Significant Portal Hypertension
(CSPH).
About Exalenz Bioscience:
Exalenz Bioscience develops and markets diagnostic and
monitoring systems that use the breath to diagnose and help manage
GI and liver conditions. The company's flagship BreathID® Hp test
detects the presence of the H. pylori bacteria, associated with
various illnesses including gastric cancer. Exalenz holds
regulatory approvals in Europe the
US and Israel for H. pylori
detection and is currently in the process of obtaining approvals
for additional applications.
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.
About Non-Alcoholic Steatohepatitis (NASH)
NASH is the most serious form of non-alcoholic fatty liver
disease (NAFLD), characterized by the buildup of extra fat in liver
cells that is not related to alcohol consumption[i]. NASH
dramatically increases the risks of cirrhosis, liver failure, and
hepatocellular carcinoma (HCC), and is an increasingly frequent
reason for liver transplantation[ii]. Currently, a liver biopsy is
the only way to definitively diagnose the condition.
Contact:
David Carey
Lazar Partners Ltd.
T: (212) 867-1768
dcarey@lazarpartners.com
[i] http://www.liverfoundation.org/abouttheliver/info/nafld/
[ii]
http://www.worldgastroenterology.org/assets/export/userfiles/2012_NASH%20and%20NAFLD_Final_long.pdf
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SOURCE Exalenz Bioscience