foralumab nasal (TZLS-401 nasal) / Tiziana Life Sci, Light Chain Biosci - LARVOL DELTA

Tiziana Life Sciences Announces University of Massachusetts Commences Dosing Intranasal Foralumab in Phase 2 Multiple Sclerosis Trial (GlobeNewswire) - "Tiziana Life Sciences, Ltd...today announced that dosing has commenced at the fourth clinical site in its ongoing Phase 2 trial evaluating intranasal foralumab in patients with non-active secondary progressive multiple sclerosis (na-SPMS). The University of Massachusetts (UMass) has now joined Brigham and Women’s Hospital (BWH), Yale Multiple Sclerosis Center, and Johns Hopkins University (JHU) Autoimmunity Center of Excellence in actively dosing participants....This blinded, placebo-controlled trial is expected to be completed by the end of 2025."

Trial status • Multiple Sclerosis

INDUCTION OF AMYLOID CLEARING MONOCTYTES WITH NASAL PROTOLLIN AND MICROGLIAL DAMPENING TREGS WITH NASAL FORALUMAB TO TREAT ALZHEIMER'S DISEASE (ADPD 2025) - "Nasal Foralumab could be a treatment for ARIA. Phase 2 placebo controlled trials of nasal Protollin and nasal Foralumab in early AD are being undertaken."

IO biomarker • Alzheimer's Disease • CNS Disorders • Hematological Disorders • Multiple Sclerosis • IL10 • NKG7 • TGFB1

Tiziana Life Sciences Announces Yale University Commences Intranasal Foralumab Dosing in Phase 2 Multiple Sclerosis Trial (GlobeNewswire) - "Tiziana Life Sciences, Ltd...today announced dosing of new patients at Yale MS Center which is participating in our multicenter Phase 2 clinical trial evaluating intranasal foralumab for non-active Secondary Progressive Multiple Sclerosis (na-SPMS). Other centers are currently enrolling include Johns Hopkins, U Mass Medical Center and Brigham and Women’s Hospital....The double blinded, multicenter placebo-controlled Phase 2 trial is expected to be completed by the end of 2025."

Trial status • Multiple Sclerosis

TILS-022: Nasal Foralumab in Patients with Non-Active Secondary Progressive Multiple Sclerosis (clinicaltrials.gov) - P2 | N=55 | Recruiting | Sponsor: Tiziana Life Sciences LTD

New P2 trial • CNS Disorders • Multiple Sclerosis

Tiziana Life Sciences Files Investigational New Drug Application with FDA for ALS Phase 2 Clinical Trial (GlobeNewswire) - "Tiziana Life Sciences, Ltd...today announced the submission of its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a phase 2 clinical trial in ALS....Upon FDA clearance of the IND application, Tiziana plans to commence a 20-patient clinical trial of two doses of Tiziana’s novel and patented therapeutic candidate, intranasal foralumab, aimed at evaluating the safety and early-stage parameters of disease improvement in Amyotrophic Lateral Sclerosis (ALS)."

IND • New P2 trial • Amyotrophic Lateral Sclerosis

Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: Tiziana Life Sciences LTD

New P1 trial

A Phase 2a Study of Foralumab Nasal in Patients with Multiple System Atrophy (MSA) (clinicaltrials.gov) - P2 | N=5 | Not yet recruiting | Sponsor: Brigham and Women's Hospital

New P2 trial • CNS Disorders • Movement Disorders • Multiple System Atrophy

Nasal Foralumab Treatment is Associated with Stability of 7T MRI Gray Matter Lesion Burden and Brain Atrophy over the First 6 Months of Therapy in Non-Active Secondary Progressive MS (ACTRIMS Forum 2025) - "Nasal foralumab was associated with stability of gray matter lesion burden in na-SPMS patients at 6 months, as evaluated by 7T MRI. The effect of foralumab on LME was mixed, though 30% of subjects had resolution of at least 1 LME focus. Benefits of foralumab on clinical status and TSPO-PET have been reported separately, and a double-blind, placebo-controlled phase 2 study in na-SPMS is currently underway."

CNS Disorders • Inflammation • Multiple Sclerosis

Tiziana Life Sciences Announces Dosing of Additional Patients in Multiple Sclerosis Expanded Access Program (GlobeNewswire) - "Tiziana Life Sciences, Ltd...today announced the dosing of an additional four patients in its Intermediate Size Patient Population Expanded Access (ISPPEA) for patients with non-active secondary progressive multiple sclerosis (na-SPMS) who do not qualify for the ongoing Phase 2a study...To date, 14 patients have now been enrolled in the expanded access program. The first 10 patients have all shown either an improvement or stability of disease within 6 months of starting treatment."

Trial status • Multiple Sclerosis

Tiziana Life Sciences Announces TV Interview with First Patient Dosed with Moderate Alzheimer’s Disease (GlobeNewswire) - "Tiziana Life Sciences...announced that its investigational drug, intranasal foralumab, was featured on a prominent News Channel. The segment highlighted the experiences of the first patient dosed in the company’s expanded access program for moderate Alzheimer’s disease....'Foralumab, administered via a novel intranasal delivery method, aims to target immune system dysregulation associated with Alzheimer's disease, potentially slowing disease progression and improving cognitive function.'"

Commercial • Alzheimer's Disease

Treatment Protocol: Intermediate-Size Patient Population Expanded Access (clinicaltrials.gov) - P=N/A | N=0 | Available | Sponsor: Tiziana Life Sciences LTD

New trial • CNS Disorders • Multiple Sclerosis

A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients (clinicaltrials.gov) - P2 | N=54 | Recruiting | Sponsor: Tiziana Life Sciences LTD | Trial completion date: Nov 2024 ➔ Nov 2025 | Trial primary completion date: Nov 2024 ➔ Nov 2025

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

Tiziana Life Sciences Announces Discovery of New Immune Biomarkers in Multiple Sclerosis Patients Treated with Nasal Foralumab (GlobeNewswire) - "Tiziana Life Sciences...announced the discovery of new immune biomarkers in patients with non-active secondary progressive multiple sclerosis (na-SPMS) treated with nasal foralumab....The study identified gene expression changes which were detected beginning three months after intranasal dosing of foralumab in our ongoing ISPPEA (or expanded access program). Key findings include modulation of: FoxP3 T regulatory cells (Tregs); CD4+ and CD8+ central memory T cells; CD14+ and CD14- monocytes; Naïve B cells....In this study, single-cell RNA sequencing (scRNAseq) of peripheral blood samples taken before and at three and six months after drug administration has revealed relevant gene expression changes associated with nasal foralumab, which has been associated with a reduction in microglial brain inflammation, as measured by advanced microglial PET scans in these same patients."

Biomarker • Multiple Sclerosis

Tiziana Life Sciences Announces First Patient with Moderate Alzheimer’s Disease Dosed with Intranasal Foralumab (GlobeNewswire) - "Tiziana Life Sciences...announced a significant milestone in its clinical development program for Alzheimer’s disease. The Company has successfully dosed the first patient with moderate Alzheimer's disease using intranasal foralumab at Brigham and Women’s Hospital in Boston, Massachusetts following on from their baseline PET scan....The study at Brigham and Women’s Hospital is part of Tiziana's broader development program for Foralumab, which includes other inflammatory and autoimmune indications."

Trial status • Alzheimer's Disease

Tiziana Life Sciences Expands Phase 2 Clinical Trial for Non-Active Secondary Progressive Multiple Sclerosis to Additional Prestigious U.S. Medical Centers (GlobeNewswire) - "Tiziana Life Sciences, Ltd...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."

Clinical protocol • CNS Disorders • Immunology • Multiple Sclerosis

Tiziana Life Sciences Announces $4 Million Grant Awarded by National Institutes of Health to Study Anti-CD3 in Alzheimer’s Disease (GlobeNewswire) - "Tiziana Life Sciences, Ltd...today announced the National Institutes of Health (NIH), National Institute on Aging have awarded a $4 Million grant to Dr. Howard Weiner as principal investigator at Brigham and Women’s Hospital to be the key research site, to study nasal anti-CD3 for the treatment of Alzheimer’s disease (AD). This significant grant will fund a key research study over the next several years, advancing preclinical and ultimately, clinical studies of intranasal anti-CD3 as a potential treatment for this devastating neurodegenerative condition...The company expects to initiate first-in-human clinical trials in Alzheimer’s Disease patients using its intranasal anti-CD3 monoclonal antibody in the coming months, marking an important step toward regulatory approval and commercialization."

Financing • Trial status • Alzheimer's Disease • CNS Disorders

Tiziana Life Sciences Granted FDA Fast Track Designation (GlobeNewswire) - "Tiziana Life Sciences, Ltd...announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its intranasal formulation of foralumab, a fully human anti-CD3 monoclonal antibody, for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS)."

Fast track • Immunology • Multiple Sclerosis

Tiziana Life Sciences to Dose First Patient with Moderate Alzheimer’s Disease with Foralumab (GlobeNewswire) - "Tiziana Life Sciences, Ltd...announced that the U.S. Food and Drug Administration (FDA) has allowed intranasal foralumab to be used under an Expanded Access (EA) IND in its first patient with moderate Alzheimer’s disease."

IND • Alzheimer's Disease • CNS Disorders

FDA Accepts Tiziana Life Sciences Fast Track Designation Submission for Treatment of Multiple Sclerosis (GlobeNewswire) - "Tiziana Life Sciences, Ltd...announced it has received acceptance of its submission for intranasal foralumab to receive Fast Track Designation approval for the treatment of non-active, secondary-progressive multiple sclerosis (na-SPMS) to the U.S. Food and Drug Administration (FDA)."

Fast track • Immunology • Multiple Sclerosis

Tiziana Life Sciences Announces Six-Month Qualitative Improvement in Neuroimaging in 80% of Multiple Sclerosis Patients Receiving Intranasal Foralumab (GlobeNewswire) - P2a | N=54 | NCT06292923 | Sponsor: Tiziana Life Sciences LTD | "Tiziana Life Sciences...announced the qualitative results for all 10 non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients enrolled in the intermediate-size patient population Expanded Access (EA) Program receiving foralumab for at least six months...'I am thrilled that 80% of the na-SPMS patients who received intranasal foralumab treatment for at least 6-months have a qualitative reduction of microglial activity as confirmed in these latest PET images.'....'With the allowance of an additional 20 patients in the EA program, the application for Orphan Drug Designation for na-SPMS, and the ongoing Phase 2a trial, Tiziana is rapidly progressing its intranasal foralumab program in multiple sclerosis.'"

P2a data • Trial status • Immunology • Multiple Sclerosis

Tiziana Life Sciences Submits Grant Application to ALS Association to Fund Clinical Trial of Intranasal Foralumab (GlobeNewswire) - "Tiziana Life Sciences, Ltd...announced it has been honored with an invitation to apply for a prestigious grant from the ALS Association head by James Berry, MD, MPH and Suma Babu, MBBS, MS, the Director and Co-Director of the Neurological Clinical Research Institute (NCRI) at Mass General Hospital, a founding member of Mass General Brigham. The grant is offered as part of the Hoffman ALS Clinical Trial Awards Program, which is specifically designated to support a groundbreaking clinical trial."

Financing • Amyotrophic Lateral Sclerosis • CNS Disorders

Tiziana Life Sciences Files for Orphan Drug Designation for Intranasal Foralumab (GlobeNewswire) - "Tiziana Life Sciences, Ltd...announced it has submitted an FDA request to obtain Orphan Drug Designation for intranasal foralumab for the treatment of non-active secondary progressive Multiple Sclerosis (na-SPMS). This request would make foralumab the first therapy for na-SPMS to receive Orphan Drug Designation. Our request is supported by clinical and non-clinical evidence of Foralumab’s effectiveness in na-SPMS. The prevalence estimates, in part, are supported from the Brigham & Women’s Hospital, Boston, Massachusetts, longitudinal study, the CLIMB data of which allowed the estimate of na-SPMS in the population."

Orphan drug • Immunology • Multiple Sclerosis

Treatment of PIRA with Nasal Foralumab Dampens Microglial Activation and Stabilizes Clinical Progression in Non-active Secondary Progressive MS (AAN 2024) - "Nasal foralumab attenuated microglial activation in na-SPMS patients with PIRA at 3 and 6 months, as evaluated by [F-18]PBR06-PET and was associated with clinical stability. Based on these positive results, a double-blind, placebo-controlled dose-ranging study of nasal-foralumab in na-SPMS with [F-18]PBR06-PET as a primary endpoint is underway."

Clinical • CNS Disorders • Fatigue • Inflammation • Multiple Sclerosis

A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients (clinicaltrials.gov) - P2 | N=54 | Recruiting | Sponsor: Tiziana Life Sciences LTD

New P2 trial • CNS Disorders • Multiple Sclerosis

NASAL IMMUNOTHERAPY OF THE MONOCTYE-MICROGLIAL AXIS TO TREAT ALZHEIMER'S DISEASE (ADPD 2024) - "Nasal Protollin and nasal Foralumab had positive immunologic and clinical effects in humans and are novel immunotherapeutic approaches to target monocytes and microglia to treatment AD and can be given in combination with anti-amyloid drugs. Phase 2 placebo controlled clinical trials of nasal Protollin and Foralumab in subjects with early AD are currently being undertaken."

IO biomarker • Alzheimer's Disease • CNS Disorders • Hematological Disorders • Inflammation • Multiple Sclerosis • HIF1A • IL10 • IL12A • IL4