Clinical trials of the new oral treatment for autoimmune diseases will begin at Hadassah University Medical Center in Jerusalem next month.Israeli and American scientists have joined forces to develop a new orally administered therapeutic treatment for autoimmune diseases. Clinical trials of the new treatment begin in Jerusalem in February.
The new product is a combination therapy that brings together intellectual property from Hadasit, the technology transfer company of Hadassah Medical Organization in Jerusalem, Harvard Medical School (HMS) and Brigham and Women’s Hospital (BWH), a teaching affiliate of Harvard Medical School. This is the first official cooperation between the organizations.
Autoimmune diseases are disorders caused by an immune response directed against the body’s own organs, tissues and cells. There are more than 80 clinically distinct autoimmune diseases, including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Type I and Type II diabetes, and Crohn’s disease.
Today in the US, autoimmune diseases are the third most common major illness. The most common of these diseases affect more than 8.5 million Americans (one in 31). According to the American Autoimmune Related Diseases Association, as many as 50 million Americans are believed to suffer from some type of autoimmune disease.
The combination therapy developed by the Israeli and American team is a cocktail of a Monoclonal Antibody (Anti-CD3) in development at Harvard Medical School, and a line of glycolipid compounds, currently in development at Hadasit, and based on research led by a senior Hadassah physician.
Clinical data shows that Glycolipid compounds, which activate specific cells in the immune system, can be used for all oral applications and have no adverse side effects. Pre-clinical studies in animal models demonstrated the same results for the monoclonal antibody. Pre-clinical studies also suggest that the oral administration of the combination of the two has a profound immune modulatory effect and in several models, a direct and beneficial influence on disease activity.
“Monoclonal antibodies are widely used in medicine intravenously but they have never been given orally in humans,” said Dr. Howard L. Weiner, a professor of neurology at Harvard Medical School, director of the Partners Multiple Sclerosis Center at Brigham and Women’s Hospital and a pioneer in the fields of oral tolerance and oral administration of the monoclonal antibody.
“It now appears possible to correct the imbalances in the immune system and subsequently treat a wide number of human diseases with an oral, non-toxic therapy. We know that both the monoclonal antibody and the glycolipid compound have a standalone therapeutic effect. However, we also have evidence, from animal models, that the combination of the two stimulates the immune system better and elicits a stronger, additive effect,” he continued.
The collaborative therapy will be tested in a Phase I clinical trial at Hadassah University Medical Center in Jerusalem. The trial begins this February in 20 healthy volunteers. It will focus on investigating the safety and dosing of the combination therapy as well as monitor for immunologic effects.
If all goes well, a second clinical trial will take place at both Hadassah and Brigham and Women’s Hospital and will include 50 patients suffering from an autoimmune disease.
“This is the first of hopefully many scientific collaborations between Hadasit and BWH/HMS, all world leaders in medical research,” said Professor Shlomo Mor-Yosef, director general of Hadassah Medical Organization. “It is through this special alliance that we strive to find a treatment for autoimmune diseases, which affect millions of people worldwide. Our joint venture is a calculated investment that we believe will not only reap an impressive return for Hadassah and its existing and potential partners, but also make a significant impact on existing treatment protocols.”