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       #Post#: 4194--------------------------------------------------
       Something for non-active SPMS? Intranasal Foralumab?
       By: agate Date: October 20, 2023, 11:55 pm
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       The recent ECTRIMS conference included a report on a small study
       using intranasal Foralumab for patients with non-active SPMS:
 (HTM) https://www.neurologylive.com/view/significant-improvements-progressive-multiple-sclerosis-through-foralumab-treatment
       #Post#: 4195--------------------------------------------------
       (Abst.) ECTRIMS2023:  Treatment of non-active SPMS w/ [Foralumab
       ]
       By: agate Date: October 21, 2023, 2:23 pm
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       Below is the abstract from the ECTRIMS/ACTRIMS conference in
       Milan this month. This is such a small study, and each of the 6
       subjects used the drug for less than 2 years.
       A couple of authors (Chitnis, Weiner) are fairly well known in
       MS research. This small study probably should be taken
       seriously. Or maybe the medical world just wanted to offer
       something for SPMS since it has been noted more than once that
       they have pretty much ignored SPMS when it comes to developing
       new drugs.
       [quote]Abstract Number: 1868/P281
       Treatment of six non-active secondary progressive MS patients
       with nasal anti-CD3 monoclonal antibody
       Tanuja Chitnis * 1,Tarun Singhal 1,Jonathan Zurawski 1,Taylor
       Saraceno 1,Thais Moreira 1,Tzu-Ying Chuang 1 ,Danielle Howard
       1,John Sullivan 1,Shrishti Saxena 1,Hrishikesh Lokhande 1,Clare
       Baecher-Allan 1,Nancy Clementi 2,Howard Weiner 1
       1Brigham and Women’s Hospital, Neurology, Boston, United
       States, 2 Clementi & Associates Ltd., Bryn Mawr, United States
       Introduction:
       There are no effective treatments for non-active secondary
       progressive MS (SPMS). In EAE, nasal anti-CD3 suppresses disease
       by inducing Tregs and dampening microglia/astrocyte inflammation
       (Mayo, 2016), and the antibody does not enter the bloodstream or
       brain. We found that a fully human anti-CD3 Mab (Foralumab)
       given nasally to healthy volunteers was safe with immune effects
       seen at 50ug (Chitnis, 2022). Nasal Foralumab reduced lung
       inflammation in COVID (Moreira, 2021) and was associated with a
       regulatory immune signature (Moreira, 2023).
       We investigated nasal Foralumab in six patients with non-active
       SPMS, under an FDA expanded access program.
       Objectives/Aims:
       To determine if nasal Foralumab has a therapeutic effect on
       patients with non-active SPMS.
       Methods:
       Six patients (3 females, 3 males) with non-active SPMS and
       clinical progression despite DMTs were treated. Nasal Foralumab
       50ug/day was administered 3x/week for 2 weeks with 1 week rest,
       constituting a treatment cycle. Clinical assessments were
       undertaken, MRI and PET brain imaging performed, and serum
       cytokines and scRNAseq measured.
       Results:
       Subject EA1 has completed 21 treatment cycles over 1.8 years
       and EA2 has completed 21 treatment cycles over 1.3 years. There
       have been no serious treatment-related adverse events,
       significant nasal irritation, or severe laboratory
       abnormalities. In EA1, EDSS, pyramidal motor score, T25FW, SDMT,
       and 9HPT stabilized. Microglial activation measured by
       [F-18]PBR06 PET scan was reduced 3 months and 6 months after
       treatment. Serum IFN-γ, IL-18, IL-1ß and IL-6 inflammatory
       cytokines were reduced and scRNAseq showed immune modulation
       with upregulation of GIMAP7 and TGFb1 gene expression and
       downregulation of NKG7 in CD3+ cells. In EA2, after 15 cycles of
       treatment, EDSS improved from EDSS 6.0 (pre-treatment) to 5.0.
       EDSS improvement was related to maximum ambulatory distance
       without cane (> 200 m). Subjects EA3-6 began treatment in
       December 2022-January 2023 and will complete their 6-month
       treatment cycle in August 2023. All clinical, laboratory, and
       available imaging results to date will be presented.
       Conclusion:
       Nasal Foralumab is a novel, non-toxic immunomodulatory
       treatment for non-active SPMS. Two patients completed over 12
       months of therapy with no severe TRAEs and experienced improved
       clinical, imaging, and immune biomarkers. 10 patients in total
       will be treated under the expanded access program and a
       multi-center placebo controlled double blind trial is
       planned.[/quote]
       #Post#: 4511--------------------------------------------------
       Intranasal foralumab receives fast-track designation as potentia
       l treatment for SPMS
       By: agate Date: August 11, 2024, 1:19 am
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       From Practical Neurology (August 7, 2024)--"Intranasal Foralumab
       Receives Fast-Track Designation as Potential Treatment for
       Nonactive SPMS":
 (HTM) https://bit.ly/3WJVfwO
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