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Galmed International, Ltd. Initiates Phase II Clinical Trial for Treatment of Fatty Liver Disease


10/14/2010 12:46:43 PM

TEL AVIV, Oct. 14, 2010 -- GalMed Medical Research, a leader in research and development of products for the treatment of chronic lipid and liver related diseases announced it has initiated the multi-center Phase II clinical trial with its proprietary, patented compound Aramchol for the treatment of conditions of NAFLD and NASH.

The Company has previously completed Phase I studies in healthy volunteers, which successfully confirmed the good safety and pharmacokinetic profile of Aramchol. The trial is to be conducted at eleven academic departments of Hepatology in Israel.

The institutions that will participate in the Phase IIA double blind, randomized, placebo controlled study include: Tel-Aviv Sourasky Medical Center, Beilinson Hospital, Meir Medical Center, Kaplan Hospital, Soroka Hospital, Hadassah Medical Organization, Hillel Yaffe Medical Center, Rambam Hospital, The Lady Davis Carmel Medical Center, Holy Family Hospital and Ziv Hospital. The Chief investigator for the trial is Professor Ran Oren, chair of the Liver & Gastroenterology Department at The Tel Aviv Sourasky Medical Center, Tel-Aviv University.

Professor Tuvia Gilat, CEO of GalMed commented, "Based on previous experimental studies as well as on recent Phase I clinical results with Aramchol, we have reason to believe this drug will be an important new option in the treatment of patients with NAFLD and NASH. This Phase II study will provide additional valuable insight into the potential benefits of Aramchol for the therapeutic management of these very chronic diseases related to lipid disorders and will hopefully confirm its safety profile also in patients.”

The study is designed to compare the changes in the concentration of liver triglycerides in patients treated with Aramchol versus placebo. Secondarily the study will be comparing liver enzymes, markers of endothelial dysfunction, insulin resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the patients treated with Aramchol and the those patients receiving the placebo.

About GalMed

Galmed Medical Research develops innovative, proprietary drugs for the treatment of chronic lipid and liver related diseases. The company has developed a series of proprietary fatty acid bile-acid conjugates (FABACs) which selectively effect several pathways in lipid metabolism, as demonstrated in several species in vivo and in human cells and tissues in vitro.

About Fatty Liver Disease

Nonalcoholic fatty liver disease (NAFLD) refers to a wide spectrum of liver disease ranging from simple fatty liver (steatosis), to nonalcoholic steatohepatitis (NASH), to cirrhosis (irreversible, advanced scarring of the liver). NAFLD is a very common disorder. It is estimated that NAFLD affects up to 33 percent of adults and over 5 percent of children. Obesity is thought to be the most common cause of fatty infiltration of the liver. Some experts estimate that about two thirds of obese adults and half of obese children may have fatty liver. About 6 percent of adult Americans and up to 20 percent of those who are obese may suffer from the more severe condition NASH. In the past ten years the rate of obesity in the United States has doubled in adults and tripled in children and teenagers, which may explain why NAFLD and NASH are becoming more common.

For More Information Contact:

Corporate: Professor Tuvia Gilat, CEO TEL: (972)-3-6938448 E-mail: tuvgilat@galmedgroup.com Media and Investors: Mitchell Benus TEL: +1 347 326 8573 E-mail: mbenus@aol.com



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