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Thes findings are consistent with the results obtained from the first patient following three months of treatment, as previously announced in March. Foralumab – afully human anti-CD3 monoclonal antibody – was well-tolerated, and improved clinical and PET imaging analyses.

Foralumab (formerly NI-0401) is the only entirely human anti-CD3 mAb, which shows reduced release of cytokines after IV administration in healthy volunteers, and in patients with Crohn’s disease.

“We are excited about the positive clinical responses seen in 2 out of 2 SPMS patients treated so far,” said Dr Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences. “Clinical data from both patients further validate our novel intranasal therapy with foralumab, which seems to overcome the blood-brain barrier to allow therapeutic action of the drug.”

Dr Howard Weiner, MD, Director of the Multiple Sclerosis Program at BWH and Chairman of Tiziana’s Scientific Advisory Board, commented: “We are very pleased by both the biological and clinical improvement observed in the second patient, after treatment with intranasal foralumab for three months, which provides confirmation that the intranasal dosing modulates the systemic immune response, and in turn dampens brain inflammation. It is encouraging to see the consistency of response between the first and second patient, and that the treatment was well tolerated.”

“Therapies to slow progression in multiple sclerosis are much needed, as there are only a few options for non-active SPMS,” added Tanuja Chitnis, MD, Principal Investigator and Professor of Neurology at Harvard Medical School (HMS) and senior neurologist at BWH and Massachusetts General Hospital. “I look forward to treating more patients under this same protocol.”