Joint Venture Initiated To Develop a New Orally Administered Therapy for Autoimmune Diseases

A joint scientific venture has been initiated to develop a new orally administered therapeutic treatment for autoimmune diseases.

Hadasit (Jerusalem, Israel), the technology transfer company of Hadassah Medical Organization; Harvard Medical School (HMS; Cambridge, MA, USA); and Brigham and Women's Hospital (BWH; Boston, MA, USA), a teaching affiliate of Harvard Medical School; announced the venture with a new product, which is a combination therapy that joins together both Hadasit and BWH/HMS intellectual property. This is the first official cooperation between Hadasit, Hadassah, Harvard Medical School, and Brigham and Women's Hospital.

"This Joint Venture is especially exciting because it establishes a wonderful and important precedent. This is the first of hopefully many scientific collaborations between Hadasit and BWH/HMS, all world leaders in medical research. We take great pride in working alongside such esteemed partners,” said Prof. Shlomo Mor-Yosef, director general, Hadassah Medical Organization (Jerusalem, Israel). "Hadassah Medical Organization and Brigham and Women's Hospital share a firm commitment to developing groundbreaking therapies for life-altering and life-threatening diseases. It is through this special alliance that we strive to find a treatment for autoimmune diseases, which affect millions of people worldwide. Clearly, there is blockbuster market potential for the ones who develop a viable treatment or cure. 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.”

The combination therapy 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, based on research led by a senior Hadassah physician. Clinical data show that the glycolipid compounds, which activate specific cells in the immune system when given orally, can be used for all oral applications and without adverse side effects. Pre-clinical studies demonstrated the same results for the monoclonal antibody, but in animal models. Pre-clinical studies also suggest that the core 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. 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,” 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.

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. These include systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, type I and type II diabetes, and Crohn's disease.

The collaborative therapy will be evaluated in a phase I safety and efficacy study in 20 healthy volunteers at Hadassah Hospital beginning in February 2008. The trial will investigate the safety and dosing of the combination therapy as well as monitor for immunologic effects. Assuming all goes well, plans are now in development for a subsequent phase I safety and efficacy study of the treatment in patients with an autoimmune disease. The second study will be conducted at both Hadassah and Brigham and Women's Hospital and will likely include up to 50 patients.


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