Tiziana Life Sciences Completes Enrollment of the First Patient Cohort for its Intermediate-Size Patient Population Expanded Access Program to Evaluate Foralumab in Non-Active Secondary Multiple Sclerosis Patients
This treatment program will evaluate dosing at the “standard” dosing of 50 mcg and, if needed, a higher 100 mcg dose of intranasal foralumab in two separate cohorts of four non-active SPMS patients each and is being conducted at Brigham and Women’s Hospital in
“We are very encouraged by the rapid enrollment of non-active Secondary Progressive Multiple Sclerosis in this study which further validates the positive investigator feedback we have received about evaluating foralumab in this patient population,” commented
Foralumab, the only entirely human anti-CD3 mAb, has shown reduced release of cytokines after intravenous (IV) administration in healthy volunteers and in patients with Crohn's disease. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T-cell receptor, orally administered foralumab modulates immune responses of T-cells and enhances regulatory T-cells (Tregs), thereby providing therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenterally-administered mAb therapy. Once-a-day treatment for 10 consecutive days with intranasal foralumab was both well tolerated and produced clinical responses in COVID-19 patients. Based on these studies, the intranasal and oral administration of foralumab offers the potential to become a well-tolerated immunotherapy for autoimmune and inflammatory diseases by the induction of Tregs.
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Source: Tiziana Life Sciences Ltd.