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Tiziana Life Sciences, Ltd. (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced for the first time, quantitative data showing improvement in White Matter Z-scores measured from PET images taken at 3 months in nasal foralumab treated patients with non-active secondary progressive multiple sclerosis (na-SPMS). White Matter Z-scores are a statistical measure used in neuroimaging studies to assess the integrity or abnormalities in structures of the brain.
Tarun Singhal, MBBS, M.D., Director of PET Imaging Program in Neurologic Diseases at Brigham and Women's Hospital, a founding member of Mass General Brigham Healthcare System, and Associate Professor of Neurology at Harvard Medical School, stated, "Last week at the American Academy of Neurology annual meeting, we presented, for the first time, quantitative [F18]PBR06-PET data showing the dampening of microglial activation, an indicator of brain inflammation, in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS) receiving intranasal foralumab. These data came from the open-label intermediate-sized patient population Expanded Access (ISPPEA) program. We calculated White Matter Z-scores to measure the effect of intranasal foralumab on microglial activation at baseline and then after foralumab treatment for three months. We saw reductions of 28% to 48%, indicating improvement in 5 out of 6 patients, and a 36% median reduction in White Matter Z-scores compared to baseline (see Figure 1). A peer-reviewed journal has published our recent work with newer [F18]PBR06-PET quantitation approaches."[1]
The full publication in Clinical Nuclear Medicine can be found here: https://journals.lww.com/nuclearmed/fulltext/9900/glial_activity_load_on_pet_reveals_persistent.1077.aspx
"I am grateful for Dr. Singhal's work advancing our intranasal foralumab program and the insight his work provides into the foralumab's effect on brain inflammation. We are seeing this additional, encouraging evidence of intranasal foralumab's effect after reporting that it attenuated microglial activation in na-SPMS patients with progression independent of relapse activity (PIRA) at 3 months as evaluated by [F-18]PBR06-PET and was associated with clinical symptom improvement or stability. Based on these positive results, a double-blind, placebo-controlled, dose-ranging study (NCT06292923) of intranasal foralumab in na-SPMS with [F-18]PBR06-PET as a primary endpoint with clinical measures of EDSS (disability) and MFIS (fatigue) is currently underway. I welcome the publication of Dr. Singhal's [F18]PBR06-PET research paper, highlighting these combined findings in Clinical Nuclear Medicine," commented Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences.
Posted In: TLSA
