Biotechnology firm Tiziana Life Sciences Ltd (NASDAQ:TLSA) said it had successfully enrolled and dosed four new patients with non-active secondary progressive multiple sclerosis (na-SPMS) in the Brigham and Women’s Hospital, a key member of the Mass General Brigham Healthcare System Expanded Access (EA) Program.
The news brings the total number of patients being followed in the EA Program to 10.
Notably, two patients have been dosed for over a year, and an additional four for six months, all without experiencing serious side effects. These findings, combining imaging, immune-biomarkers, and clinical measures, constitute the first comprehensive dataset on patients receiving long-term intranasal foralumab.
Foralumab, administered through novel drug delivery routes, has been a focal point in obtaining essential information on dosing, drug utilization, and patient feedback. The release of the FDA guidance in September 2023 underscores the importance of EA programs as part of confirmatory evidence.
The Intermediate Size EA Program for na-SPMS marks a significant stride in Tiziana Life Sciences' commitment to offering treatment options for individuals grappling with the debilitating form of MS. Simultaneously, the company aims to gather crucial regulatory evidence on its innovative investigational therapy, foralumab, a fully human anti-CD3.
Tiziana has recently initiated a Phase 2a trial in na-SPMS, and those ineligible for this trial may be considered for the EA program.
Gabriele Cerrone, Tiziana’s acting CEO, said that the firm’s dedication to multiple sclerosis research is “unwavering.”
Cerrone told shareholders that the anticipated enrollment of the first patient in the Phase 2a na-SPMS trial, expected to begin this month, “brings us another step closer to fulfilling our mission of improving the quality of life for individuals living with na-SPMS."
Tiziana Life Sciences, a clinical-stage biopharmaceutical company, is pioneering transformative drug delivery technologies to facilitate innovative routes for immunotherapy in the development of groundbreaking therapies. Its lead candidate, intranasal foralumab, the sole fully human anti-CD3 monoclonal antibody (mAb), has shown both a positive safety profile and promising clinical responses.