Full Press Release Details
Tiziana Life Sciences Expands Phase 2 Clinical
Trial for Non-Active
Secondary Progressive Multiple Sclerosis to Additional Prestigious U.S. Medical Centers
NEW YORK, December 4, 2024 - 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 the expansion
of its Phase 2 clinical trial evaluating intranasal foralumab for non-active secondary progressive multiple sclerosis (SPMS). The trial
sites include esteemed institutions across the Northeast of the United States.
Additional trial sites include:
represent leaders in medical research and neurology, with a history of pioneering studies in multiple sclerosis. Their inclusion enhances
the trial's reach and brings together top-tier expertise with innovative facilities to evaluate Tiziana's promising approach to
addressing SPMS. The rationale in selecting sites in the Northeast is to have all trial participants receive their PET scans at
a single imaging site at Invicro, located at New Haven, Connecticut to minimize the variability of the PET scans.
Non-active SPMS remains a significant unmet need within the multiple
sclerosis community, with no FDA approved therapeutic options available. Tiziana's intranasal foralumab offers a unique approach, targeting
inflammation and modulating the immune system without systemic immune suppression.
"We are honored to collaborate with these prestigious institutions
as we further expand our clinical trial," said Ivor Elrifi, CEO of Tiziana Life Sciences. "This milestone demonstrates our
dedication to advancing innovative treatments for patients living with SPMS and underscores the potential of our platform to address complex
neurodegenerative diseases."
The Phase 2 trial aims to generate robust, high-quality data to support
Tiziana's regulatory strategy. For further information on the trial, including enrollment criteria and site details, visit https://clinicaltrials.gov/study/NCT06292923.
Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological
drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. 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. Immunomodulation by nasal anti-CD3
mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2]
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). 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 with either an improvement or stability of disease seen within 6 months in all patients.
The FDA has recently allowed an additional 20 patients to be enrolled in this EA program.
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 more information about Tiziana Life Sciences and its innovative
pipeline of therapies, please visit www.tizianalifesciences.com
For further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com