Full Press Release Details
Tiziana Life Sciences Announces Additional Clinical
Improvements Among Multiple Sclerosis Patients in its Expanded Access Program
NEW YORK, April 22, 2024 - 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 additional positive clinical results from its intermediate sized Expanded Access Program
(EAP) for non-active secondary progressive multiple sclerosis (na-SPMS) patients. The data demonstrate multiple improvements in foralumab-treated
patients, with 70% showing an improvement in fatigue after six months of follow-up. Fatigue is a debilitating symptom for many MS patients
and is measured by the Modified Fatigue Impact Scale (MFIS).
"All patients in this na-SPMS study had previously clinically
progressed on ocrelizumab. They subsequently were enrolled in our EA program and received 6-months of intranasal foralumab," stated
Dr. Tanuja Chitnis, M.D., Principal Investigator and Professor of Neurology at Harvard Medical School and senior neurologist at Brigham
and Women's Hospital, a founding member of Mass General Brigham Healthcare System. "All 10 foralumab-treated patients stabilized
or improved in key clinical measures, and seven showed clinical meaningful improvement in their fatigue at six months as measured by the
MFIS. Other key clinical outcome measures included the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk Test (T25WT) and Pyramidal
Scores in a disease state that typically shows a decline in function over time. I am pleased to see the continued clinical response to
intranasal foralumab from patients enrolled in our expanded access na-SPMS program."
Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life
Sciences, commented "Fatigue is a pervasive and challenging symptom for individuals living with MS, impacting their daily lives
in profound ways. The clinically meaningful improvement in fatigue levels seen in seven out of ten patients, as well as the stabilization
or improvements in other key clinical outcome measures that were seen in all patients, underscores the potential of Tiziana's investigational
therapy to address this critical unmet need."
Fatigue in MS, as measured via the MFIS, refers to an overwhelming
sense of physical, mental, and emotional exhaustion that is disproportionate to the level of activity or effort exerted. It is a major,
common, and often debilitating symptom experienced by many individuals with MS. It differs from the typical tiredness that everyone experiences
from time to time. In the context of MS, it is called primary fatigue' and is a direct result of damage to the central nervous
system. This kind of fatigue can significantly impact a person's daily life and functioning.
The findings, which are summarized in Table 1 below, show broad-based
six-month improvements across various key measures for multiple sclerosis. Secondary progressive multiple sclerosis is hallmarked by an
increase of disability over time. The table below shows a stabilization or an improvement in physical function of the various clinical
measures over a six-month period.
| - Denotes stabilization |
| Denotes improvement |
Activated T cells 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
began screening patients 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.
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, 2022, 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 authority.
For further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
LifeSci Advisors, LLC