Tiziana Announces Positive Qualitative Six-Month PET Scan Results With Intranasal Foralumab Treating Multiple Sclerosis Patients Diagnosed With Non-Active Secondary Progressive MS (na-SPMS) Five out of six patients in FDA authorized Expanded Access Program are showing a qualitative reduction in microglia activation (a key biomarker being observed)
Phase 2 trial screening for na-SPMS to begin in November 2023
Tarun Singhal, M.B.B.S., M.D., Director of the PET Imaging Program in Neurologic Diseases, associate neurologist and nuclear medicine physician at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, and Assistant Professor of Neurology at Harvard Medical School, commented, “Upon review of the baseline and six-month PET scans of the latest cohort of four Expanded Access patients, three out of the four scans suggested a qualitative reduction in the microglial PET signal. When combined with my assessment of the first two Expanded Access patients at six-months, five of the six suggested a reduction in qualitative microglial PET signal. An example of this can be seen in the graphic below, titled, “Figure 1”, 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, M.D., 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, “With six patients now dosed in our na-SPMS EA program, I feel that Dr. Singhal’s readout of the six-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 six-month qualitative na-SPMS PET readout by Dr. Singhal is very encouraging and will enable us to rapidly advance foralumab in Phase 2a testing to address patients afflicted with this devasting disease who currently have no FDA-approved treatments available.” Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. Paul Spencer, Business Development and Investor Relations
email: info@tizianalifesciences.com
ikoffler@lifesciadvisors.com
1 https://www.pnas.org/doi/10.1073/pnas.2220272120
2 https://www.pnas.org/doi/10.1073/pnas.2309221120
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/99285d68-dd89-4d8c-9da6-06dec6217d5a