Tiziana Life Sciences (NASDAQ: TLSA) has announced new biomarker data from a late-breaking poster presented by investigators from Brigham and Women’s Hospital, Boston, showing nasal foralumab downregulates cerebrospinal fluid (CSF) inflammation, upregulates neuroprotective pathways, and correlates with reduced microglial activation on PET scans in non-active secondary progressive multiple sclerosis (na-SPMS) patients with progression independent of relapse activity (PIRA).
The late-breaking poster reports results from 10 patients with na-SPMS and PIRA treated with nasal foralumab in an open-label expanded-access program. Patients underwent 14 paired evaluations of PET scans (measuring microglial activation via m-GALP z-scores) and untargeted data-independent acquisition CSF proteomics at baseline and during up to six months of treatment.
In a statement, Tarun Singhal, MD, lead author and neurologist at Brigham and Women’s Hospital, commented, “This late-breaking poster provides the first direct link between reduced microglial PET signal and favorable CSF proteomic shifts during nasal foralumab treatment in na-SPMS with PIRA. The correlations demonstrate that [F-18]PBR06-PET is biologically tied to the inflammatory and neurodegenerative processes driving progression in SPMS, and that CSF proteomics can serve as a practical biomarker of therapeutic response.”
Howard L. Weiner, MD, chairman of Tiziana’s scientific advisory board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, added, “Nasal foralumab continues to show a unique ability to dampen smoldering CNS inflammation while promoting neuroprotection. These integrated imaging and proteomic results strengthen the mechanistic rationale for our ongoing Phase 2 program and offer new tools to monitor disease modification in progressive MS.”
