Hadasit, the technology transfer company of Hadassah Medical Organization, and Harvard Medical School's Brigham and Women’s Hospital announced the successful results of a Phase I study of a new drug for diseases stemming from abnormal activity of the immune system. The drug is orally administered and the goal is to treat immune mediated diseases such as diabetes, Crohn's disease, psoriasis, multiple sclerosis, and liver diseases.
The study, which was conducted at Hadassah Hospital in Jerusalem, showed the treatment to be safe, with no adverse side effects. Researchers claimed the drug was also shown to have a clear modulatory effect on the immune system. Data demonstrated that there was an increase in the regulatory cells that control the immune response in the body.
There was also a decrease in the cytokines that induce inflammation. The results enabled the clinical team to identify the mechanism of the effects as well as to determine which cells in the immune system are involved in the process of defense.
Harvard Medical School professor Dr. Howard L. Weiner pointed out, “Any time you go from pre-clinical to clinical you never know what you are going to see." Referring to the positive results, Weiner noted that "to our pleasant surprise, we were able to modulate the immune system in exactly the way we wanted". He added "When a monoclonal antibody is administered intravenously, which is the way they are given in medicine, the body has been known to rebel by building immunity to it. This was not the case with the orally administered drug.” Weiner is considered a pioneer in the fields of oral tolerance and oral administration of the monoclonal antibody.
Hadasit CEO Dr. Rafi Hofstein claimed, “This was one of the most complicated studies ever performed on human beings to show that immune modulatory effects can be achieved based on the concept of oral tolerance and oral dosing."
Phase II studies are anticipated to begin during the second half of 2008. Indications under consideration include multiple sclerosis, Hepatitis C, Diabetes Type II and fatty liver disease.
Jerusalem-based Hadasit promotes and commercializes Hadassah Medical Organization's intellectual property and research and development capabilities. Brigham and Women's Hospital is a nonprofit teaching affiliate of Harvard Medical School.
Published by Globes [online], Israel business news - www.globes-online.com - on April 17, 2008
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