Full Press Release Details
Life Sciences Plans to Submit IND for Phase 1 Trial of Intranasal Foralumab in Alzheimer's Disease Patients
NEW YORK, Oct. 12, 2022 -- 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 it plans to submit an Investigational New Drug Application
(IND) for a Phase 1 Trial of intranasal foralumab in Alzheimer's disease patients after receiving an affirmative written response from
the FDA on a Pre-Investigational New Drug Application (PIND). Tiziana plans on filing the IND for Alzheimer's disease by the third
quarter of 2023 upon the completion of requested toxicology studies, then starting its Phase 1 program by the end of 2023.
"I am thrilled to see the company
advancing foralumab into another promising central nervous system (CNS) -related therapeutic area with high unmet need," commented
Gabriele Cerrone, Executive Chairman and interim Chief Executive Officer of Tiziana Life Sciences. "Intranasal foralumab's
unique action on regulatory T-cells should allow us to study multiple CNS inflammatory pathology indications for this unique drug, including
in Multiple Sclerosis (MS) and Amyotrophic Lateral Sclerosis (ALS)."
"We have spent years studying intranasal
anti-CD3, or foralumab, in inflammatory CNS-related disease models in animals," said Howard L. Weiner, M.D., Co-Director of the Ann
Romney Center for Neurologic Diseases at Brigham and Women's Hospital. "We look forward to evaluating intranasal foralumab
in patients with early symptomatic Alzheimer's disease, where we believe its locally acting anti-inflammatory mechanism of action
strongly believes that many inflammatory CNS disease pathologies could improve with intranasally administered foralumab and as
such, we hope to study additional neurological disease states over time,", stated Matthew Davis, M.D., RPh, Chief Scientific Officer
and Chief Medical Officer of Tiziana Life Sciences.
Foralumab (formerly NI-0401), the only entirely
human anti-CD3 mAb, has shown reduced release of cytokines after IV administration in healthy volunteers and in patients with Crohn's
disease. In a humanized mouse model (NOD/SCID IL2 c-/-), it was shown that while targeting the T-cell receptor, orally administered
foralumab modulates immune responses of the T-cells and enhances regulatory T-cells (Tregs), thereby providing therapeutic benefit in
treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb
therapy. Once a day treatment for 10 consecutive days with intranasal foralumab was both well tolerated and produced clinical responses
in COVID-19 patients. Based on these studies, the intranasal and oral administration of foralumab offers the potential to become a well-tolerated
immunotherapy for autoimmune and inflammatory diseases by the induction of Tregs.
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, oral and inhalation approaches in development have the potential to provide an improvement
in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana's two lead candidates, intranasal
foralumab, the only fully human anti-CD3 mAb, and milciclib, a pan-CDK inhibitor, have both 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
Hana Malik, Business Development and Investor
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
LifeSci Advisors, LLC