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Tiziana Life Sciences Announces Interview Highlighting Intranasal Foralumab for the Treatment of Moderate Alzheimer's Disease

Key Takeaway: Tiziana Life Sciences has announced advancements in the treatment of moderate Alzheimer's disease through their lead candidate, intranasal foralumab, highlighted in a recent interview. The treatment showed promising results in the first patient, Joe Walsh, who experienced notable improvements in engagement and social interaction after undergoing monoclonal antibody therapy via nasal administration. This development represents a significant step in Alzheimer's research, targeting brain inflammation, which is crucial in disease progression. Tiziana's novel approach to drug delivery may improve efficacy and safety over traditional intravenous methods.

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POSITIVE FACTORS

  • Promising results from the first patient demonstrating improved engagement.
  • Intranasal foralumab shows significant reduction in brain inflammation.
  • Innovative delivery method for immunomodulation with favorable safety profile.

Full Press Release Details

Life Sciences Announces Interview Highlighting Intranasal Foralumab for the Treatment of Moderate Alzheimer's Disease
YORK, May 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 advancements in moderate
Alzheimer's disease treatment, showcased in a recent feature on a national public radio station across the United States. The advancement
involves the use of Tiziana's novel nasal spray, foralumab, which is designed to combat brain inflammation, marking a step forward
in moderate Alzheimer's research and treatment.
the exclusive interview, Dr. Howard Weiner shared promising results from the first patient, Joe Walsh, who received the treatment. Mr.
Walsh, accompanied by his wife Karen, underwent a transformative experience at Brigham and Women's Hospital, Boston, MA, where he received
a monoclonal antibody via nasal administration. Intranasal foralumab, targets immune cells in the brain to mitigate inflammation, a key
contributor to Alzheimer's progression.
never seen anything like this, and we've tried a lot of things. So I think this is something special," stated Dr. Howard Weiner.
"The reduction in brain inflammation observed in Joe Walsh represents a significant step forward in our understanding and treatment
of Alzheimer's disease. We are witnessing remarkable progress with foralumab."
Walsh, Joe's wife and steadfast supporter, recounted their journey from diagnosis to participation in the clinical trial. "It's
been a rollercoaster," she shared. "Since Joe started the treatment, we've noticed him becoming more engaged and enjoying social
a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed
intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label
intermediate sized Expanded Access (EA) Program (NCT06802328) with either
an improvement or stability of disease seen within 6 months in all patients. In addition, 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 (NCT06292923).
is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. The non-active SPMS intranasal foralumab
Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by intranasal foralumab represents a novel
avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2]
Tiziana Life Sciences
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 applications.
more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.
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, 2024, 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.
Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379

Frequently Asked Questions

What is intranasal foralumab?

Intranasal foralumab is a fully human anti-CD3 monoclonal antibody designed to reduce brain inflammation in Alzheimer's disease.

How does foralumab treat Alzheimer's disease?

Foralumab targets immune cells in the brain to mitigate inflammation, aiding in the treatment of moderate Alzheimer's.

Where was the positive case study presented?

The positive case study of Joe Walsh receiving foralumab was featured on a national public radio station.

What is Tiziana Life Sciences focusing on?

Tiziana Life Sciences is focused on developing innovative therapies using intranasal delivery for immunotherapy.

Is foralumab safe for patients?

Foralumab has shown a favorable safety profile and clinical responses in prior studies.

Last updated: May 23, 2025