Crohn’s trial commences25 Mar 2022 12:43
Tiziana Announces Initiation of Phase 1b Clinical Trial in Crohn’s Disease Patients to Evaluate Oral Capsules of Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody’.
Dr. Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of Tiziana, commented, "The oral route of administration is the preferred route for all pharmaceuticals. The “Holy Grail” for biologics is the “switch” from parenteral (IV, SC) to oral administration as it is the most economical, non-invasive, and convenient route with respect to patient's quality of life and compliance. We have developed proprietary formulation technologies, enabling oral, nasal, and inhalation routes for administration of antibodies, to facilitate local action at the respective target sites. We believe this Phase 1b study is a logical first step towards the clinical validation of oral immunotherapy with foralumab capsules, to provide local action rather than systemic delivery, for CD treatment.”
Howard Weiner, M.D., Director of the Multiple Sclerosis Program at the Brigham and Women’s Hospital (BWH) and Chairman of Tiziana's Scientific Advisory Board, commented, “Treatment with orally or nasally administered foralumab is a novel physiological approach to stimulate the mucosal immune system to induce disease-modifying benefits while minimizing the toxicities that are commonly associated with the traditional intravenous or subcutaneous immunotherapies. In this regard, the first validation of our innovative approach came from our recently reported clinical results showing positive clinical benefits in a patient with secondary progressive multiple sclerosis (SPMS), who was treated for 6 months with intranasally administered foralumab3."
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