Hadassah

FDA Grants Approval for US Clinical Trials of Hadassah-Developed Technology to Treat Fatty Liver Disease

Wednesday, Dec 17 2014

A new drug technology, developed at the Hadassah Medical Organization to treat fatty liver disease--a condition with no approved effective drug treatment--was given the go-ahead by the United States Food and Drug Administration (FDA) for a Phase 2 multi-center clinical trial in the US.

In its severe form (called nonalcoholic steatohepatitis-NASH), fatty liver disease can lead to cirrhosis and liver cancer. Current estimates reveal that at least five percent of the Western world’s population suffers from the disease. The majority of these patients also have diabetes, high blood lipids, and obesity.

The new technology was developed by Prof. Yaron Ilan, Director, Department of Internal Medicine and former president of the Israel Liver Association, and his team in Hadassah’s Liver Unit. Based on feeding natural antibodies against intestinal bacteria associated with fatty liver disease, the treatment reduces inflammation by directly affecting the activity level of regulatory T cells in the liver and fat tissues. “The new drug is based on a novel discovery that bacteria in our gut are relevant for the induction of inflammation in our body, which is associated with liver disease, diabetes, and obesity” said Prof. Ilan. “The new therapy is safe and has no side effect, and we hope the results of the phase II trial will enable us to move forward with its development as a treatment for diabetes and fatty liver disease”.

Hadasit, Hadassah’s technology transfer arm, and Immuron, an Australian biopharmaceutical company, worked together to develop the product. The collaborative effort combines Hadassah’s oral immune modulation approach with antibodies produced by Immuron.

The multi-center clinical trial will involve 120 patients in several leading medical centers in the US and Australia. The cohort will receive the treatment for six months, while monitored for the state of their liver disease, diabetes, and lipid profile.

Clinical trials were already conducted at Hadassah, which confirmed the safety and efficacy of the treatment.

Read about the 2009 discovery of treatment for fatty liver disease

Comments

No comments yet.
First Name
Email
Comment
Enter this word:

Related Stories

alt_text

Wednesday, Feb 22 2017

Fetal Surgery Lessens Crippling Spinal Damage

History was made at Hadassah Ein Kerem Hospital in Jerusalem on Thursday, February 9 when a team of Israeli surgeons successfully operated on a 5-month-old fetus using a new procedure that only three doctors in the world can perform, to alleviate some of the crippling effects of spina bifida.

READ MORE ›
alt_text

Tuesday, Feb 21 2017

Hadassah Cardiologists Publicize Israel’s Dramatic Decrease in Cardiovascular Death

Prof. Emeritus Mervyn Gotsman and Prof. Israel Gotsman of Hadassah Hospital’s Heart Institute have coauthored an article which appeared in the European Heart Journal, highlighting the fact that “between 1998 and 2012, mortality from cardiovascular disease in Israel has fallen from 162 to 80 per 100,000 residents--a decrease of 50 percent.”

READ MORE ›
alt_text

Tuesday, Feb 21 2017

Ambassadors of Health for Heart Smart Living: A Unique Hadassah Program

Knowing that the workplace is where people spend vast quantities of time, the Hadassah Medical Organization’s Linda Joy Pollin Cardiovascular Wellness Center for Women launched a unique course to encourage heart healthy living—during the work day.

READ MORE ›
alt_text

Tuesday, Feb 21 2017

Hadassah Brings Health Empowerment to East Jerusalem

The increased incidence of diabetes in the Arab community, as well as the 60 percent higher rate of cardiovascular mortality among Arab women led the Hadassah Medical Organization’s Linda Joy Pollin Cardiovascular Wellness Center for Women to develop a community-based program to cultivate leadership that embraces and advocates for healthy living which will reduce diabetes in this population.

READ MORE ›

Donation Questions

donorservices@hadassah.org

(800) 928-0685

Membership Questions

membership@hadassah.org

(800) 664-5646

Missions Department

missions@hadassah.org

(800) 237-1517

Contact Us

40 Wall Street

New York, NY 10005

support@hadassah.org

More ›

Show More