Hadasit Technology Transfer Company of Hadassah University Hospital Ltd., Harvard Medical School, and its affiliate Brigham and Women’s Hospital have set up a joint scientific venture to develop a new orally administered therapeutic treatment for autoimmune diseases. The parties will own the venture in equal shares. This is the first official cooperation between the three hospitals.
The hospitals' 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 shows 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 Robert L. Kroc Professor of Neurology at Harvard Medical School, the 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.
Hadassah Medical Organization director general Prof. Shlomo Mor-Yosef said, “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." He added, "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 collaborative therapy will be tested in a Phase I safety and efficacy trial on 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. A subsequent Phase I trial is planned for the treatment in patients with an autoimmune disease, which will be conducted at both Hadassah and Brigham and Women’s Hospital, and will probably include up to 50 patients.
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.
Published by Globes [online], Israel business news - www.globes-online.com - on January 23, 2008
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