Tiziana Life Sciences LTD — Biomedical Watch V2

Traitements10programmes

Essais5liés

Publications4liées

SourceDBlocale

Traitements

10

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
ForalumabForalumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases. The goal of this Phase 2a, randomized, double-blind placebo-controlled, multicenter dose-ranging study is to evaluate the use of nasal foralumab in patients with non-active secondary progressive multiple sclerosis (SPMS). The primary objectives that this study aims to answer are: 1. To determine the safety and tolerability of 50 μg/dose and 100 μg/dose of foralumab nasal compared to placebo 2. To investigate the effect of foralumab relative to placebo on the change from baseline \[18F\]PBR06-positron emission tomography (PET) scans for microglial activation, after 12 weeks (3) months of study treatment.	SEP	Phase 2	Immunomodulation	United States	À vérifier
Foralumab NasalDescription non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé.	Sclérose latérale amyotrophique	Phase 2	Immunomodulation		À vérifier
Foralumab TZLS-401 100 µgOnly subjects that have completed TILS-021, a Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients are eligible to be enrolled in TILS-022. TILS-022 is a 6-month open-label extension study with an opportunity for dose to be escalated based on the subject's clinical status. All subjects initiate dosing in this trial at a dose of nasal foralumab 50 µg 3 days a week (Monday, Wednesday, and Friday) for 2 weeks, followed by a 1-week rest, comprising a 3-week cycle. At week 12, the dose may be escalated to 100 µg according to pre-defined dose escalation rules. Study TILS-022 is intended to ensure all participants in TILS-021, a placebo-controlled study, will be able to receive open-label nasal foralumab for 6 months. The option to extend this trial for longer than 6 months will be explored with FDA by the Sponsor.	SEP	Phase 2	À vérifier	United States	À vérifier
Foralumab TZLS-401 50 µgThis is an open-label, intermediate-size patient population expanded access treatment study utilizing 1 dose level of nasal Foralumab (50 µg/dosing day) with the possibility of increasing to 100 µg/dosing day. The goal of this expanded access clinical trial is to evaluate safety, tolerability, and immune effects of intranasal Foralumab in non-active secondary progressive multiple sclerosis patients. The primary objective is to treat patients who have failed current available therapy. Participants will visit the clinic for testing and follow-up every cycle (3 weeks) while administering the medication at home if able three times weekly.	SEP	À vérifier		United States	À vérifier
Intranasal Foralumab SolutionThe primary objective is to establish the safety of administration of intranasal Foralumab in non-active primary and secondary progressive Multiple Sclerosis (MS) patients in a multiple ascending dose format in escalating doses for 14 consecutive days.	SEP	Phase 1	À vérifier		À vérifier
Foralumab TZLS-401 50 µgThis is an open-label, intermediate-size patient population expanded access treatment study utilizing 1 dose level of nasal Foralumab (50 µg/dosing day) with the possibility of increasing to 100 µg/dosing day. The goal of this expanded access clinical trial is to evaluate safety, tolerability, and immune effects of intranasal Foralumab in non-active secondary progressive multiple sclerosis patients. The primary objective is to treat patients who have failed current available therapy. Participants will visit the clinic for testing and follow-up every cycle (3 weeks) while administering the medication at home if able three times weekly.	SEP	À vérifier		United States	À vérifier
Intranasal Foralumab SolutionThe primary objective is to establish the safety of administration of intranasal Foralumab in non-active primary and secondary progressive Multiple Sclerosis (MS) patients in a multiple ascending dose format in escalating doses for 14 consecutive days.	SEP	Phase 1	À vérifier		À vérifier
Foralumab TZLS-401 100 µgOnly subjects that have completed TILS-021, a Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients are eligible to be enrolled in TILS-022. TILS-022 is a 6-month open-label extension study with an opportunity for dose to be escalated based on the subject's clinical status. All subjects initiate dosing in this trial at a dose of nasal foralumab 50 µg 3 days a week (Monday, Wednesday, and Friday) for 2 weeks, followed by a 1-week rest, comprising a 3-week cycle. At week 12, the dose may be escalated to 100 µg according to pre-defined dose escalation rules. Study TILS-022 is intended to ensure all participants in TILS-021, a placebo-controlled study, will be able to receive open-label nasal foralumab for 6 months. The option to extend this trial for longer than 6 months will be explored with FDA by the Sponsor.	SEP	Phase 2	À vérifier	United States	À vérifier
ForalumabForalumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases. The goal of this Phase 2a, randomized, double-blind placebo-controlled, multicenter dose-ranging study is to evaluate the use of nasal foralumab in patients with non-active secondary progressive multiple sclerosis (SPMS). The primary objectives that this study aims to answer are: 1. To determine the safety and tolerability of 50 μg/dose and 100 μg/dose of foralumab nasal compared to placebo 2. To investigate the effect of foralumab relative to placebo on the change from baseline \[18F\]PBR06-positron emission tomography (PET) scans for microglial activation, after 12 weeks (3) months of study treatment.	SEP	Phase 2	Immunomodulation	United States	À vérifier
Foralumab NasalDescription non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé.	Sclérose latérale amyotrophique	Phase 2	Immunomodulation		À vérifier

Essais cliniques

5

Molécule	Indication / population	Phase	NCT	Titre	Statut
Foralumab Nasal	Sclérose latérale amyotrophique	Phase 2	NCT07688239	The BANYAN Trial, an ALS MyMatch Trial Evaluating Safety, Biomarker Activity, and Microglial Activation of Nasal Foralumab	NOT_YET_RECRUITING
Foralumab	SEP	Phase 2	NCT06292923	A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients	ACTIVE_NOT_RECRUITING
Foralumab TZLS-401 100 µg	SEP	Phase 2	NCT06890923	TILS-022 — Nasal Foralumab in Patients With Non-Active Secondary Progressive Multiple Sclerosis	RECRUITING
Intranasal Foralumab Solution	SEP	Phase 1	NCT05029609	Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS	WITHDRAWN
Foralumab TZLS-401 50 µg	SEP	À vérifier	NCT06802328	Intermediate-Size Patient Population Expanded Access: Foralumab in Non-Active Secondary Progressive MS Patients	AVAILABLE

Publications

4

Molécule	Indication / population	Titre	Journal	Date
Foralumab		Dampening of Microglial Activation With Nasal Foralumab Administration in Moderate Alzheimer's Disease Dementia.	Clinical nuclear medicine
Foralumab		Nasal foralumab treatment of PIRA induces regulatory immunity, dampens microglial activation and stabilizes clinical progression in non-active secondary progressive MS.	medRxiv : the preprint server for health sciences
Foralumab		Monoclonal Antibodies as Therapeutic Agents in Autoimmune and Neurodegenerative Diseases of the Central Nervous System: Current Evidence on Molecular Mechanisms and Future Directions.	International journal of molecular sciences
Foralumab TZLS-401 100 µg		Nasal administration of anti-CD3 mAb (Foralumab) downregulates and increases and expression in T cells in subjects with COVID-19.	Proceedings of the National Academy of Sciences of the United States of America