Tiziana Life Sciences Announces Continued Clinical Improvements in the Second Patient with Secondary Progressive Multiple Sclerosis (SPMS) After Six Months of Dosing with Intranasal Foralumab
- The second Expanded Access patient (EA2) demonstrated improved walking as measured by gait stability and endurance
- The patient showed clinically significant improvement in the Expanded Disability Status Scale (EDSS).
- The 6-month PET imaging will occur in Q4 2022 to confirm simultaneous improvements in microglial activation
“Coupled with our PET imaging data demonstrating inhibition of microglial activation, I am truly excited and encouraged by the clinical benefits shown so far for the first two expanded access patients receiving intranasal foralumab for SPMS,” commented
Dr. Tanuja Chitnis, M.D., Professor of Neurology and the Principal investigator of the clinical study at BWH said, “Patients with non-active SPMS normally do not improve over a six-month time course. I am very encouraged by these results and look forward to seeing this patient’s PET imaging to determine if there is a continued reduction in microglial activation to correlate with the improvement we are observing in the patient’s clinical exam.”
Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, has shown reduced release of cytokines after 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 the 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 parenteral 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.
About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal, oral and inhalation approaches in development have the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s two lead candidates, intranasal foralumab, the only fully human anti-CD3 mAb, and milciclib, a pan-CDK inhibitor, have both demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
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Source: Tiziana Life Sciences Ltd.