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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:
HTML 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":
HTML https://bit.ly/3WJVfwO
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