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Wednesday, June 8, 2022

Tiziana Up After MS Data From Second Patient

 

  • Tiziana Life Sciences  reported clinical results from the second patient with Secondary Progressive Multiple Sclerosis (SPMS) in the ongoing study as part of an expanded access program.
  • These results confirm the previously reported data from the first SPMS patient after three months of treatment of the first SPMS patient. 
  • The treatment with foralumab, a fully human anti-CD3 monoclonal antibody, was well-tolerated and improved clinical and PET imaging analyses.
  • After three months of treatment with intranasal foralumab, the patient showed improvement as measured by PET imaging and neurologic examination. 
  • Approximately 10-30% reduction in PET signal was seen across brain regions in the second SPMS patient, comparable to the PET changes seen in the first SPMS patient. 
  • Clinically, the Timed 25-Foot Walk test and neurologic exam were also improved. 
  • The FDA has now allowed Tiziana to treat an additional eight SPMS patients. 
  • Although the original dosing regimen with intranasal therapy with foralumab will remain the same (50 mcg), the revised regimen has a dose escalation of up to 100 mcg (MWF), an option to improve clinical benefit.

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