| Revision as of 10:44, 31 October 2011 editBeetstra (talk | contribs)Edit filter managers, Administrators172,031 edits Script assisted update of identifiers for the Chem/Drugbox validation project (updated: 'CAS_number').← Previous edit |
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{{Short description|Monoclonal antibody}} |
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{{cs1 config|name-list-style=vanc|display-authors=6}} |
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{{Drugbox |
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{{Drugbox |
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| Verifiedfields = changed |
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| Verifiedfields = changed |
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| verifiedrevid = 450066847 |
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| verifiedrevid = 458275670 |
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| type = mab |
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| type = mab |
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| image = |
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| image = |
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| source = u |
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| source = u |
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| target = ] |
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| target = ] |
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<!--Clinical data--> |
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<!--Clinical data --> |
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| tradename = |
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| tradename = |
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| Drugs.com = |
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| Drugs.com = |
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| pregnancy_US = <!-- A / B / C / D / X --> |
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| pregnancy_US = <!-- A / B / C / D / X --> |
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| pregnancy_category= |
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| pregnancy_category= |
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| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled--> |
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| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled --> |
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| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII --> |
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| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII --> |
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| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM --> |
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| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM --> |
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| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V --> |
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| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V --> |
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| legal_status = |
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| legal_status = |
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| routes_of_administration = |
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| routes_of_administration = |
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⚫ |
<!-- Pharmacokinetic data --> |
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<!--Pharmacokinetic data--> |
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| bioavailability = |
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| bioavailability = |
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| protein_bound = |
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| protein_bound = |
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| metabolism = |
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| metabolism = |
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| elimination_half-life = |
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| elimination_half-life = |
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| excretion = |
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| excretion = |
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<!-- Identifiers --> |
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<!--Identifiers--> |
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| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}} |
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| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}} |
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| ChemSpiderID = NA |
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| ChemSpiderID = none |
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| CAS_number_Ref = {{cascite|correct|??}} |
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| CAS_number_Ref = {{cascite|changed|??}} |
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| CAS_number = <!-- blanked - oldvalue: 946415-64-1 --> |
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| CAS_number = 946415-64-1 |
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| ATC_prefix = none |
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| ATC_prefix = none |
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| ATC_suffix = |
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| ATC_suffix = |
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| PubChem = |
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| PubChem = |
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| DrugBank_Ref = {{drugbankcite|correct|drugbank}} |
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| DrugBank_Ref = {{drugbankcite|correct|drugbank}} |
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| DrugBank = |
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| DrugBank = |
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<!-- Chemical data --> |
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| ⚫ |
<!--Chemical data--> |
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| chemical_formula = |
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| chemical_formula = |
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| molecular_weight = |
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| molecular_weight = |
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}} |
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}} |
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'''Foralumab''' is an immunomodulator. It binds to ].<ref>{{cite journal | author = ] | title = International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 103 | journal = WHO Drug Information | year = 2010 | url = http://www.who.int/medicines/publications/druginformation/INN_PL103.pdf | format=PDF}}</ref> |
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'''Foralumab''' (TZLS-401), being researched by Tiziana Life Sciences<ref name=":0">{{Cite report |url=https://clinicaltrials.gov/study/NCT06292923 |title=A Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients |last=Tiziana Life Sciences LTD |date=2024-03-15 |publisher=clinicaltrials.gov |issue=NCT06292923}}</ref>) is a fully human ] that binds to ] of the ]-] complex.<ref>{{cite journal |author=] |year=2010 |title=International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 103 |url=https://www.who.int/medicines/publications/druginformation/INN_PL103.pdf |journal=WHO Drug Information}}</ref> It is currently being studied in a ], ] ]-controlled, multicenter dose-ranging study in a nasal formulation in patients with non-active secondary progressive ] (SPMS).<ref name=":0" /> |
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== Clinical research == |
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=== Nasal administration === |
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==== Phase 1 ==== |
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Nasal foralumab was studied at the ], at the ] Center. Twenty-seven (9 per group) ] received either nasal foralumab (10ug, 50ug, or 250ug daily for 5 days) or they received nasal ]. Nasal foralumab induced ] ] and reduced CD4+ ]. Foralumab induced LAP, TIGIT, and ] ] molecules. The treatment was well tolerated by all subjects. The researchers concluded that the Immune effects of nasal foralumab were optimal at the 50ug dose. |
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==== Phase 2 - Non-active secondary progressive - Multiple sclerosis ==== |
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Nasal foralumab is currently being studied in the United States in a ], ] ]-controlled, multicenter dose-ranging study in a nasal formulation in patients with non-active secondary progressive ] (SPMS). The two primary ]s are 1) To determine the safety and tolerability of 50 μg/dose and 100 μg/dose of foralumab nasal compared to placebo and 2) To investigate the effect of foralumab relative to placebo on the change from baseline PBR06]]-] (PET) scans for ] activation, after 12 weeks (3) months of study treatment.<ref name=":0" /> |
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===== Phase 2 - Non-active secondary progressive - Alzheimer's disease ===== |
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Dr. ] announced that nasal foralumab has been cleared by the FDA to be studied in a 6 month phase 2 trial to assess safety, cognition and reduction in microglia PET imaging.<ref>{{Cite web | vauthors = Weiner H |date=August 16, 2023 |title=Received FDA approval to treat Alzheimer's disease with nasal anti-CD3 (foralumab) in a 6 month phase 2 trial |url=https://twitter.com/weinerlabhms/status/1691908932623806543 }}</ref> |
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===== Phase 2 - COVID-19 ===== |
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Nasal foralumab was studied in 39 patients with mild to moderate ]. They were randomized into 1) ] {standard of care plus a placebo}, 2) 100 μg/dose of nasal foralumab and 3) 100 μg/dose of nasal foralumab plus ]. Both nasal foralumab alone and nasal foralumab combined with dexamethasone demonstrated more rapid clearance of lung infiltrates as measured by chest CT compared to the control group.<ref>{{cite journal | vauthors = Moreira TG, Matos KT, De Paula GS, Santana TM, Da Mata RG, Pansera FC, Cortina AS, Spinola MG, Baecher-Allan CM, Keppeke GD, Jacob J, Palejwala V, Chen K, Izzy S, Healey BC, Rezende RM, Dedivitis RA, Shailubhai K, Weiner HL | title = Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study | journal = Frontiers in Immunology | volume = 12 | pages = 709861 | date = 2021 | pmid = 34475873 | pmc = 8406802 | doi = 10.3389/fimmu.2021.709861 | doi-access = free }}</ref> |
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=== Intravenous administration === |
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==== Phase 1 - Crohn's disease ==== |
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Intravenous foralumab was studied in 39 patients with confirmed active ] of at least 6 months duration. The patients were given intravenous infusion daily for 5 days. This limited study did not show efficacy.<ref>{{cite journal | vauthors = van der Woude CJ, Stokkers P, van Bodegraven AA, Van Assche G, Hebzda Z, Paradowski L, D'Haens G, Ghosh S, Feagan B, Rutgeerts P, Dijkstra G, de Jong DJ, Oldenburg B, Farhan M, Richard T, Dean Y, Hommes DW | title = Phase I, double-blind, randomized, placebo-controlled, dose-escalation study of NI-0401 (a fully human anti-CD3 monoclonal antibody) in patients with moderate to severe active Crohn's disease | journal = Inflammatory Bowel Diseases | volume = 16 | issue = 10 | pages = 1708–1716 | date = October 2010 | pmid = 20848453 | doi = 10.1002/ibd.21252 }}</ref><ref name="pmid32585338">{{cite journal | vauthors = Giuffrida P, Di Sabatino A | title = Targeting T cells in inflammatory bowel disease | journal = Pharmacological Research | volume = 159 | issue = | pages = 105040 | date = September 2020 | pmid = 32585338 | doi = 10.1016/j.phrs.2020.105040 | s2cid = 220073839 }}</ref> |
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== References == |
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== References == |
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{{Reflist}} |
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<references/> |
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{{monoclonals for immune system}} |
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{{monoclonals for immune system}} |
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] |
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{{monoclonal-antibody-stub}} |
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{{monoclonal-antibody-stub}} |
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{{antineoplastic-drug-stub}} |
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