Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced a significant update regarding non-active secondary progressive multiple sclerosis (SPMS) patients treated with h intranasal foralumab in the company’s expanded access program.
A reduction in microglial activation, which is associated with lowered inflammation in the brain, has now been found in five of six patients in three-month PET scans.
Activated microglia are believed to play a prominent role in the pathogenesis of neuroinflammatory diseases including multiple sclerosis, Alzheimer’s disease and amyotrophic lateral sclerosis (ALS), the company said.
In SPMS, inflammation in the brain occurs in microglia, the brain’s immune cells, which drive the neurodegeneration of brain cells. During the inflammatory process, microglia are involved in the destruction of myelin, the protective sheath covering of nerve fibers and contribute to the formation of MS lesions.
“To see a reduction in microglial activation in 5 out of 6 na-SPMS patients in only 3 months is extraordinary,” said Howard Weiner, chairman of Tiziana's scientific advisory board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital.
“This finding is even more remarkable because all of the 6 expanded access patients’ na-SPMS had clinically regressed on ocrelizumab treatment. I am excited to follow this program to see if the improvement in the 3-month PET scans will translate to clinical improvement in the coming months.”
Tiziana CEO Gabriele Cerrone agrees.
“Our Phase 2a multi-center, double-blinded, placebo-controlled trial in na-SPMS uses the 3-month PET scan as the primary outcome measure and our Expanded Access data from the first 6 patients give us increasing conviction in the potential for a positive outcome,” Cerrone said. “We believe this trial design will provide a quick validation of our intranasal foralumab asset and will allow the company to proceed to the next clinical phase of development in na-SPMS.”
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