Core Viewpoint - Tiziana Life Sciences is advancing its investigational therapy, intranasal foralumab, for patients with non-active secondary progressive multiple sclerosis (na-SPMS) through an expanded access program, demonstrating positive early results in patient outcomes [1][3][4]. Group 1: Expanded Access Program - The na-SPMS expanded access program allows patients who do not qualify for the ongoing Phase 2a clinical trial to receive treatment with intranasal foralumab, aiming to provide therapeutic benefits to those lacking access to promising treatments [2][4]. - A total of 14 patients have been enrolled in the expanded access program, with the first 10 patients showing either improvement or stability of disease within 6 months of treatment [1][4]. Group 2: Drug Candidate Overview - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally, with positive outcomes observed in patients with na-SPMS [4][5]. - The FDA has approved the enrollment of an additional 20 patients in the expanded access program, indicating regulatory support for the therapy's development [4]. Group 3: Company Commitment and Future Directions - The CEO of Tiziana Life Sciences emphasized the company's commitment to addressing unmet medical needs in na-SPMS and advancing its therapies through both expanded access and clinical trials [3]. - Tiziana Life Sciences is focused on developing novel treatments for neuroinflammatory disorders, including Alzheimer's Disease and ALS, leveraging its innovative drug delivery technologies [3][6].
Tiziana Life Sciences Announces Dosing of Additional Patients in Multiple Sclerosis Expanded Access Program