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Tiziana Life Sciences announces collaboration with Parexel Biotech to conduct phase 1b/2 clinical trial in patients with Crohn’s Disease
First Ever Study with take-home capsules of Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody Potential to be a safer and effective alternative to the
About this update from Tiziana Life Sciences Ltd
[{"type":"text","content":"First Ever Study with take-home capsules of Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody Potential to be a safer and effective alternative to the intravenous immunotherapies currently used for Crohn’s DiseaseCrohn’s Disease Therapeutics Market Size $4.7 Billion by 2025 Phase1b/2 clinical study to be conducted in the United States and several European countries NEW YORK and LONDON, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (Nasdaq: TLSA; AIM: TILS) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced it is collaborating with Parexel Biotech (“Parexel”), a division of a leading global clinical research organization (“CRO”), Parexel International (IRL) Limited, to conduct a global Phase 1b/2 trial with enteric-coated capsules of formulated Foralumab, the only fully human anti-CD3 monoclonal antibody (“mAb”) - as a therapy for patients with moderate to severe Crohn’s Disease (\"CD\"). This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. and Europe. Dr. Howard L. Weiner, chairman of the scientific advisory board of Tiziana Life Sciences, commented:“We understand that this will be the first-ever study with ‘take-home’ capsules of any mAb for immunotherapies for human diseases. We believe the scientific rationale for oral treatment with Foralumab is logical to facilitate topical action at the inflamed sites in the gastrointestinal tract. This potentially ground-breaking approach for immunotherapies originated in my laboratory and was subsequently reported by other researchers in the field.” “Recently, we also successfully demonstrated that nasally administered Foralumab is not only well-tolerated, but also produced desirable immunological responses. Oral and nasal administration routes are both physiologic approaches to stimulate the mucosal immune system to induce disease modifying benefits.” The CD therapeutic market size will be worth $4.7 billion by 2025, according to Grand View Research1. CD is a chronic disorder of the immune system that causes inflammation throughout the digestive tract. Although the specific causes of CD...