By Rachael Green, Benzinga
Tiziana (Nasdaq: TLSA) is following-up with anticipated human data and announced the acceptance of a late-breaking poster at the 39th Congress of the European Committee for Treatment and Research of Multiple Sclerosis (ECTRIMS) being held in Milan, Italy, October 11-13, 2023. The company will present a poster titled, Treatment Of Six Non-Active Secondary Progressive MS With Nasal Anti-CD3 Monoclonal Antibody (Foralumab): Safety, Biomarker, And Disability Outcomes, which is a follow-up from the positive data presented in June on 5 out of 6 patients.
The key takeaway is that Tizianas research through its FDA authorized Expanded Access program has shown continued improvement in SPMS patients over time treated with foralumab, the Companys intranasally administered anti-CD3 monoclonal antibody. In June, Tiziana announced a reduction in microglial activation as seen in 3-month Positron Emission Tomography (PET) scans in a total of 5 of 6 patients treated. The safety and biomarker data presented at ECTRIMS will include a clinical update on all 6 patients and will include six-month of follow-up with a PET scan. Activated microglia are believed to play a prominent role in the pathogenesis of neuroinflammatory diseases including multiple sclerosis, Alzheimers disease and amyotrophic lateral sclerosis (ALS).
A reduction in microglial activation is associated with lowered inflammation in the brain. Inflammation in the brain drives the disease pathology in multiple sclerosis. In SPMS, inflammation in the brain occurs in microglia, the brains immune cells, which drive the neurodegeneration of brain cells. During the inflammatory process associated with SPMS, microglia are involved in the destruction of myelin, the protective sheath covering of nerve fibers, and contribute to the formation of MS lesions.
The Company announced in September advancing site selection for the SPMS phase 2a trial, which will have up to ten new clinical sites across the US. The news followed an Investigator's Meeting with principal investigators at Brigham and Women's Hospital, a founding member of Mass General Brigham Healthcare System, to begin site initiation.
Matthew W. Davis, M.D., RPh, Chief Operating Officer and Chief Medical Officer of Tiziana Life Sciences, stated in the press release, "As planned for this quarter, we are on track and have begun site initiation visits so patient enrollment begins in this critical clinical trial. Advancing our lead anti-CD3 therapeutic, foralumab, in na-SPMS into Phase 2a will enable Tiziana to define novel endpoints, such as PET imaging, a similar target endpoint in our Expanded Access program (EAP). We are encouraged as five out of six patients in our open-label EAP have improved by qualitative analysis in their PET scans (3 months of treatment) compared to baseline. Phase 2a na-SPMS study assesses the same outcome measure, but now, and for the first time for this novel therapeutic, in a double-blind, randomized placebo control, a multi-center trial is now underway.
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