Exalenz Bioscience Ltd. (TASE:EXEN), which develops and manufactures medical devices for gastrointestinal and liver conditions, announced on Sunday that it received FDA approval for a joint clinical trial with Galectin Therapeutics Inc. (NASDAQ: GALT)
The company's product, the BreathID, will be used to track and diagnose patients in a second-stage clinical trial of GR-MD-02, an experimental treatment for liver cirrhosis caused by NASH (fatty liver disease).
Galectin Therapeutics is conducting a multicenter, double-blind, placebo-controlled Phase 2 trial with 156 patients to evaluate the safety and effect of the drug.
The trial should not place a financial burden on Exalenz, which is mostly expected to provide medical devices and specialized systems.
Exalenz CEO Raffi Werner said "reports indicate that NASH affects nearly 10% of the US population; we are looking at a significant medical need without any currently approved medication. The current means to diagnose and track developments of NASH are all invasive, like a livery biopsy or HVPG.
"We look forward to working with Galectin Therapeutics in the clinical trial and believe that our non-invasive breath test has potential to assist doctors in matching patients to treatments and in more efficiently tracking patients afterwards.
"The data that will be collected from the trial may be used, together with data from another trial conducted by the company, as basis for a future FDA approval for implementation for the liver," said Werner.
Published by Globes [online], Israel business news - www.globes-online.com - on August 2, 2015
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