Tiziana, a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, has announced that a reduction in activated microglia — as seen in 6-month Positron Emission Tomography (PET) scans — has now been observed in a total of 5 of the 6 patients with non-active secondary-progressive multiple sclerosis (na-SPMS) treated with intranasal foralumab in its Expanded Access Programme (EAP).
Activated microglia are believed to play a prominent role in the pathogenesis of neuroinflammatory and neurodegenerative diseases, including multiple sclerosis, Alzheimer’s disease and amyotrophic lateral sclerosis (ALS).
Tarun Singhal, Director of the PET Imaging Programme in Neurologic Diseases, commented: “Upon review of the baseline and 6-month PET scans of the latest cohort of 4 EAP patients, 3 out of the 4 scans suggested a qualitative reduction in the microglial PET signal.
When combined with my assessment of the first two EAP patients at 6-months, 5 of the 6 suggested a reduction in qualitative microglial PET signal.
An example of this can be seen in the image above, showing the deactivation of this signal in patient EA6. This is promising from an imaging standpoint and further studies are needed to confirm these findings using additional quantitative approaches."
Howard L. Weiner, MD, Chairman of Tiziana's Scientific Advisory Board, added: “With 6 patients now dosed in our na-SPMS EAP, I feel that Dr Singhal’s readout of the 6-month PET scans strongly supports our previously announced 3-month clinical findings.”
Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences, commented: “I believe that the 6-month qualitative na-SPMS PET readout by Dr Singhal is very encouraging and will enable us to rapidly advance foralumab in Phase IIa testing to address patients afflicted with this devasting disease who currently have no FDA-approved treatments available.”
