Full Press Release Details
Positive Qualitative Six-Month PET Scan Results With Intranasal Foralumab Treating Multiple Sclerosis Patients Diagnosed With Non-Active
Secondary Progressive MS (na-SPMS)
NEW YORK, October 13, 2023 -
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 that a reduction in activated
microglia, as seen in six-month Positron Emission Tomography (PET) scans, has now been observed in a total of five of the six
patients with non-active secondary-progressive multiple sclerosis (na-SPMS) treated with intranasal foralumab in its Expanded Access
Program (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, or ALS.
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."
play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the
T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell
subsets. This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects.
The non-active SPMS intranasal foralumab Phase 2 trial is expected to start screening in November of 2023. Immunomodulation by nasal
anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.1,2
About Tiziana Life Sciences
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.
For further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development and Investor
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
LifeSci Advisors, LLC