Full Press Release Details
Tiziana Life Sciences Announces Positive Results
in Treating Spinal Cord Injury With Nasal Anti-CD3
NEW YORK, January 23, 2025 - Tiziana Life Sciences, Ltd. (Nasdaq:
TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies
with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced results from studies
using a nasal anti-CD3 monoclonal antibody in traumatic spinal cord injury (SCI).
Spinal cord injury is a devastating global health issue with profound
implications for both mortality and morbidity. The inflammatory response mediated by microglia is a critical component in the pathogenesis
of SCI. In these studies, the preclinical model was subjected to a spinal cord injury and then was treated with nasal anti-CD3, resulting
in notable advancements in motor functions.
Furthermore, spinal cord injuries (SCIs) are complex neurotraumatic
wounds affecting military Service members, their families, Veterans, and the general population. These are serious injuries with long-term
consequences requiring lifelong care. It is estimated that about 300,000 individuals are living with an SCI, and this number continues
to grow as over 17,000 new cases occur in the U.S. each year (https://cdmrp.health.mil/scirp/default).
"Our pre-clinical findings underscore the pivotal role of nasal
anti-CD3 in modulating microglial inflammation associated with spinal cord injury," Dr. Howard Weiner, Chairman of Tiziana's
Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women's Hospital, a founding
member of Mass General Brigham healthcare system.
Dr. Saef Izzy, Associate Professor of Neurology at Harvard Medical
School, commented, "Treatment with nasal anti-CD3 not only dampened microglial activation but also led to marked improvements in
motor function among the injured models. These results hold promise for a transformative therapeutic approach in SCI."
CEO of Tiziana Life Sciences, Ivor Elrifi, highlighted the strategic
implications, stating, "We are swiftly advancing towards expanding our nasal foralumab technology from successful applications in
neurologic diseases like secondary progressive multiple sclerosis to now encompass spinal cord injury. This underscores our commitment
to pioneering treatments that address significant unmet medical needs."
Foralumab is a fully human anti-CD3 monoclonal antibody that has been
shown to stimulate T regulatory cells when dosed intranasally. Intranasal foralumab is currently being studied in a Phase 2a, randomized,
double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis
Activated T cells play an important role in the inflammatory process.
Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development, 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 observed in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. 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 currently in clinical
development, 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
For more information about Tiziana Life Sciences and its innovative
pipeline of therapies, please visit www.tizianalifesciences.com.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking statements.
These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections
about its industry, its beliefs, and assumptions. Words such as anticipates,' expects,' intends,' plans,' believes,' 'seeks,' estimates,'
and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance
and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult
to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements.
The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements,
which reflect the view of the Company only as of the date of this announcement. Actual results may
differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties
related to market conditions and other factors described more fully in the section entitled Risk Factors' in Tiziana's
Annual Report on Form 20-F for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission.The
forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company
will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events,
circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory
For further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com