The FDA has allowed evaluation of Tiziana Life Sciences Plc's TLSA nasal administration with foralumab in a secondary progressive multiple sclerosis (SPMS) patient at the Brigham and Women's Hospital (BWH), Harvard University.
- The patient will be treated under an Individual Patient Expanded Access IND.
- The treatment is planned to start in the second quarter of this year and will continue for six months.
- Investigators will follow this patient with detailed routine safety, neurological imaging, and PET studies to evaluate microglial imaging.
- Previously, Tiziana completed a Phase 1 trial of multiple ascending doses once a day, dosing for five consecutive days with nasally administered Foralumab in healthy subjects.
- The treatment was well-tolerated with no drug-related safety issues reported at any dose up to 250 mg of the quantities.
- Earlier today, the company announced a controlled Phase 2 trial in Brazil for foralumab in moderate to severe hospitalized COVID-19 patients.
- Price Action: TLSA shares are trading 7.9% higher at $2.86 in market hours on the last check Tuesday.
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