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

Thursday, Jun 21 2018

Traveling with Ruth

Ruth Radiano, Head Nurse at Hadassah Hospital Mount Scopus, is an extraordinary woman, whose resume reads like a novel. I recently had the distinct pleasure of meeting her and hearing her speak, and in just five minutes with her, I felt as though I was with a Hadassah sister.

READ MORE ›
alt_text

Wednesday, Jun 20 2018

First in Israel: Hadassah Uses Innovative Technology to Treat Cancer in Spine

A multidisciplinary team at Hadassah Hospital Ein Kerem recently employed an innovative technology to treat cancer metastases near the spinal cord--a first for Israel.

READ MORE ›
alt_text

Tuesday, Jun 19 2018

American Journal of Ophthalmology Article Celebrates the Centennial of Hadassah Ophthalmology

The centennial anniversary of the Hadassah Medical Organization's Department of Ophthalmology is celebrated in the May issue of the American Journal of Ophthalmology, with an article by the immediate past director, Prof. Jacob Pe'er, and the current director, Prof. Itay Chowers.

READ MORE ›

Tuesday, Jun 12 2018

Hadassah Ophthalmology Department Research Highlighted by JAMA

Thanking the Hadassah Medical Organization’s researchers for their ”excellent submission” to JAMA Ophthalmology regarding a multi-center international study of the variable effectiveness of treatment for neovascular age-related macular degeneration (nAMD), the editors explained that their article was one of just a few from 12 JAMA on-line journals to be highlighted in The JAMA Network Reader this weekend.

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