Assessment of Foralumab Safety and Modulation of Microglial Activation Evaluated by PET Imaging in Patients with Early Symptomatic Alzheimer's Disease

This phase 2a study will research the safety and tolerability of Foralumab, a human anti-CD3 antibody. An antibody is a molecule secreted by the immune system. These molecules are created to identify a specific pathogen. Previous data on experimental mice has suggested that Foralumab increases the immune system activity in the brain to reduce the inflammation of microglia, the brain's main immune cells. This combination of increased immune reactivity and less microglia inflammation may improve the immune response throughout the brain. Alzheimer's disease and other forms of dementia are characteristically known for the build-up of certain proteins in the brain. This trial will evaluate whether nasal Foralumab can improve cognition in participants with mild cognitive impairment due to early Alzheimer's or dementia.
The trial will ask participants to administer Foralumab nasally three times a week for eight weeks. The administration will occur intermittently, with breaks between each dosing cycle. Participants will also receive brain scans (Amyloid PET and MRI), undergo cognitive testing, blood draws, and physical, neurological, and nasal exams. Volunteers are expected to remain in the trial for six months.

Start Date01 Apr 2025

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

[+1]

NCT06890923

/ RecruitingPhase 2

An Open Label, Multicenter Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

Only 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.

Start Date04 Mar 2025

Sponsor / Collaborator

Tiziana Life Sciences Ltd.

100 Clinical Results associated with Foralumab

100 Translational Medicine associated with Foralumab

100 Patents (Medical) associated with Foralumab

Literatures (Medical) associated with Foralumab

14 Mar 2023·Proceedings of the National Academy of Sciences of the United States of AmericaQ1 · CROSS-FIELD

Nasal administration of anti-CD3 mAb (Foralumab) downregulates NKG7 and increases TGFB1 and GIMAP7 expression in T cells in subjects with COVID-19

Q1 · CROSS-FIELD

Article

Author: Mangani, Davide ; G Moreira, Thais ; Murphy, Liam ; Weiner, Howard L ; Paul, Anu ; Kuchroo, Vijay ; Izzy, Saef ; Rezende, Rafael M ; Lanser, Toby B ; Gauthier, Christian D ; Chitnis, Tanuja ; Matos, Kimble T F ; Healy, Brian C ; Baecher-Allan, Clare M

T cells are present in early stages of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and play a major role in disease outcome and long-lasting immunity. Nasal administration of a fully human anti-CD3 monoclonal antibody (Foralumab) reduced lung inflammation as well as serum IL-6 and C-reactive protein in moderate cases of COVID-19. Using serum proteomics and RNA-sequencing, we investigated the immune changes in patients treated with nasal Foralumab. In a randomized trial, mild to moderate COVID-19 outpatients received nasal Foralumab (100 μg/d) given for 10 consecutive days and were compared to patients that did not receive Foralumab. We found that naïve-like T cells were increased in Foralumab-treated subjects and NGK7 + effector T cells were reduced. CCL5,IL32,CST7,GZMH,GZMB,GZMA,PRF1 , and CCL4 gene expression were downregulated in T cells and CASP1 was downregulated in T cells, monocytes, and B cells in subjects treated with Foralumab. In addition to the downregulation of effector features, an increase in TGFB1 gene expression in cell types with known effector function was observed in Foralumab-treated subjects. We also found increased expression of GTP-binding gene GIMAP7 in subjects treated with Foralumab. Rho/ROCK1, a downstream pathway of GTPases signaling was downregulated in Foralumab-treated individuals. TGFB1,GIMAP7 , and NKG7 transcriptomic changes observed in Foralumab-treated COVID-19 subjects were also observed in healthy volunteers, MS subjects, and mice treated with nasal anti-CD3. Our findings demonstrate that nasal Foralumab modulates the inflammatory response in COVID-19 and provides a novel avenue to treat the disease.

28 Feb 2022·Journal of acupuncture and meridian studies

Injection Effect of Anti-CD3 Monoclonal Antibody on Primo Vessel in Lymph Vessel of Rabbit with Lipopolysaccharide-Induced Inflammation

Article

Author: Lee, Sang-Suk ; Choi, Jong-Gu ; Choi, Sang-Heon

Background:

The primo vascular system can be viewed as a circulatory system that plays a therapeutic function in regenerating the body tissue. The anti-CD3 monoclonal antibody was used as an immunotherapeutic agent to treat the novel coronavirus infection (COVID-19). Objectives: In this study, we observed the effect of injecting lymph nodes with Foralumab, an anti- human CD3 epsilon therapeutic monoclonal antibody, on primo vessels.

Methods:

The structure and atomic stoichiometry of the antibody were determined by transmission electron microscopy and energy dispersive spectroscopy. Alcian blue dying solution was injected into the lymph nodes of the abdominal vena cava of rabbits, and the solution further flowed into the lymph vessels.

Results:

A primo vessel with primo nodes stained with Alcian blue was clearly visible in the lymph vessel. By injecting Foralumab into lymph nodes of rabbits with lipopolysaccharide-induced inflammation, the floating primo vessel in the lymph vessel appeared thicker and was distinctly visible.

Conclusion:

The observation of the primo vessel post-treated with Foralumab in the inflamed lymphatic system suggests the possibility of a functional role of the primo vascular circulatory system in pathophysiological conditions.

01 Sep 2020·Pharmacological researchQ2 · MEDICINE

Targeting T cells in inflammatory bowel disease

Q2 · MEDICINE

Review

Author: Giuffrida, Paolo ; Di Sabatino, Antonio

T cells play a pivotal role in the immune response underlying inflammatory bowel disease (IBD) pathogenesis. On this basis, over the past 25 years several drugs have assessed to target T cells in IBD patients. Amongst anti-CD3 antibodies, visilizumab and foralumab did not show clinical efficacy in ulcerative colitis (UC) and Crohn's disease (CD) patients, respectively, whereas otelixizumab has been tested in vitro only. The anti-CD4 BF-5 and cM-T412, and the anti-CD25 basiliximab and daclizumab were not effective in CD and UC patients, respectively. The anti-NKG2D antibody NNC0142-0002 showed clinical benefit in CD patients, in particular in biologic naïve ones, in a randomized, double-blind, parallel-group, placebo-controlled trial. The anti-CD40L M90 and the GSK1349571A blocking calcium release-activated calcium (CRAC) channels, which are involved in the T cell activation and proliferation, were tested only in ex vivo/in vitro experiments. Apart from ustekinumab, all the other drugs targeting T cell-derived cytokines failed. The reinduction of lamina propria T cell apoptosis is a mechanism to modulate T cell survival exploited by cyclosporin A, azathioprine and anti-tumor necrosis factor-α agents, such as infliximab, adalimumab and golimumab. In this article, we review the drugs targeting T cells via surface receptors, via T cell-derived cytokines, via CRAC channels or by inducing apoptosis.

146

News (Medical) associated with Foralumab

27 May 2025

·www.globenewswire.com

Tiziana Life Sciences Announces Interview Highlighting Intranasal Foralumab for the Treatment of Moderate Alzheimer’s Disease

May 23, 2025 -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced advancements in moderate Alzheimer's disease treatment, showcased in a recent feature on a national public radio station across the United States. The advancement involves the use of Tiziana’s novel nasal spray, foralumab, which is designed to combat brain inflammation, marking a step forward in moderate Alzheimer's research and treatment. In the exclusive interview, Dr. Howard Weiner shared promising results from the first patient, Joe Walsh, who received the treatment. Mr. Walsh, accompanied by his wife Karen, underwent a transformative experience at Brigham and Women's Hospital, Boston, MA, where he received a monoclonal antibody via nasal administration. Intranasal foralumab, targets immune cells in the brain to mitigate inflammation, a key contributor to Alzheimer's progression. "I've never seen anything like this, and we've tried a lot of things. So I think this is something special," stated Dr. Howard Weiner. "The reduction in brain inflammation observed in Joe Walsh represents a significant step forward in our understanding and treatment of Alzheimer's disease. We are witnessing remarkable progress with foralumab." Karen Walsh, Joe's wife and steadfast supporter, recounted their journey from diagnosis to participation in the clinical trial. "It's been a rollercoaster," she shared. "Since Joe started the treatment, we've noticed him becoming more engaged and enjoying social activities again." The full interview can be accessed here: https://www.tizianalifesciences.com/interview-aired-nationwide-highlighting-intranasal-foralumab-treating-moderate-alzheimers-disease/ Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923). Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2] Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. [1] https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2220272120 [2] https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2309221120 The content above comes from the network. if any infringement, please contact us to modify.

ImmunotherapyClinical Result

15 May 2025

·www.globenewswire.com

Journal of Clinical Nuclear Medicine Publishes Results of Tiziana’s Nasal Foralumab in Study Treating Moderate Alzheimer's Disease

NEW YORK, May 15, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced the publication of a new study in the Journal of ‘Clinical Nuclear Medicine’ demonstrating that intranasal administration of foralumab significantly dampened microglial activation in a 78-year old patient with moderate Alzheimer's disease (AD) treated as part of a Food and Drug Administration (FDA) expanded access program. The findings, published in the prestigious ‘Clinical Nuclear Medicine’ journal, highlight a promising avenue in the treatment of neurological disorders. This case represents the first use of 18F-PBR06-PET in a patient with moderate AD dementia and the first published report of an AD patient treated with nasal-foralumab. The study, led by Dr. Tarun Singhal and Dr. Howard Weiner of Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, utilized advanced PET imaging with the [F-18]PBR06 tracer to assess microglial activation before and after treatment. The findings revealed a notable reduction in neuroinflammation following intranasal foralumab administration. Figure 1. Image Source: Singhal T et al. Dampening of Microglial Activation with Nasal Foralumab Administration in Moderate Alzheimer’s Disease Dementia. Clinical Nuclear Medicine 2025 May 13. doi: 10.1097/RLU.0000000000005955. Online ahead of print.A, 18F-PBR06-PET shows significant decreased standardized uptake value (SUV) after 3 months of treatment (bottom row) with nasal-foralumab as compared to baseline (top row). B, SUV-ratio (SUVR) images demonstrate a decrease in PET signal following treatment, particularly in bilateral precuneus, posterior cingulate, bilateral parietal cortices and cerebellum (bottom row) as compared with pre-treatment baseline (top row). C, A baseline amyloid-positive 18F-Florbetapir-PET scan in the patient D, z-score maps of 18F-PBR06-PET focusing on the precuneus, posterior cingulate, and anterior cingulate regions show abnormally increased microglial activation in these regions (left) before treatment, which decreased following treatment with nasal-foralumab (right). “The marked decrease in microglial PET signal following nasal-foralumab treatment provides preliminary evidence that intranasal foralumab can modulate microglial activity in Alzheimer's disease. This supports the potential efficacy of nasal foralumab in targeting microglial activation in AD,” said Tarun Singhal, M.B.B.S., M.D., Associate Professor of Neurology at Harvard Medical School, Director of the PET Imaging Program in Neurologic Diseases, and Associate neurologist and nuclear medicine physician at Brigham and Women’s Hospital. “Given the role of microglia in neurodegeneration, these results are encouraging and warrant further investigation in larger, controlled studies with additional quantitative approaches.” “These findings from Dr. Singhal et al, are consistent with our previously reported effects of nasal- foralumab in decreasing microglial activation in non-active secondary progressive multiple sclerosis patients,” Commented Ivor Elrifi, CEO of Tiziana Life Sciences. “There are currently no approved disease-modifying therapies for moderate Alzheimer’s Disease, and it is clearly an area of unmet need. A phase-2a study of nasal-foralumab in mild Alzheimer’s is being initiated.” Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development for intranasal delivery. By modulating T cell function, it aims to reduce inflammation in the central nervous system. Previous studies have shown its potential in multiple sclerosis and other neuroinflammatory conditions. The full study is available online in Clinical Nuclear Medicine at: https://journals-lww-com.libproxy1.nus.edu.sg/nuclearmed/Fulltext/9900/dampening_of_microglial_activation_with_nasal.1721.aspx. About Foralumab Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923). Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2] About Tiziana Life Sciences Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com. Forward-Looking Statements Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Tiziana’s Annual Report on Form 20-F for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority. For further inquiries: Tiziana Life Sciences LtdPaul Spencer, Business Development, and Investor Relations+44 (0) 207 495 2379email: info@tizianalifesciences.com [1] https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2220272120 [2] https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2309221120 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cd486638-7caa-40f2-8c97-1c9c48a3ea9e

Phase 2Clinical ResultImmunotherapy

12 May 2025

·www.globenewswire.com

Tiziana Life Sciences Announces Purchase of Shares by Chairman

NEW YORK, May 12, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody, today announces that its Executive Chairman and Founder, Mr. Gabriele Cerrone, has purchased 15,000 common shares at $1.55 per share, bringing his total holding to 43,252,143 common shares, which is 37.02% of issued share capital. About ForalumabForalumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by intranasal foralumab represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2] About Tiziana Life SciencesTiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com. For further inquiries: Tiziana Life Sciences LtdPaul Spencer, Business Development, and Investor Relations+44 (0) 207 495 2379email: info@tizianalifesciences.com [1] https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2220272120 [2] https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2309221120

Phase 2Immunotherapy

100 Deals associated with Foralumab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Foralumab	-	DB16170

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 2	United States	Tiziana Life Sciences Ltd.	01 Apr 2025
Multiple Sclerosis, Secondary Progressive	Phase 2	United States	Tiziana Life Sciences Ltd.	15 Nov 2023
Multiple Sclerosis	Phase 2	United Kingdom	Tiziana Life Sciences Ltd. (United Kingdom)	27 Apr 2023
COVID-19	Phase 2	-	Tiziana Life Sciences Ltd.	30 Apr 2022
COVID-19 respiratory infection	Phase 2	-	Tiziana Life Sciences Ltd.	30 Apr 2022
Diabetes Mellitus, Type 2	Phase 2	-	Tiziana Life Sciences Ltd.	01 Dec 2017
Nonalcoholic Steatohepatitis	Phase 2	-	Tiziana Life Sciences Ltd.	01 Dec 2017
Acute cellular graft rejection	Phase 2	France	NovImmune SA	22 Nov 2007
Acute rejection of renal transplant	Phase 2	France	NovImmune SA	01 Aug 2007
Crohn Disease	Phase 2	-	NovImmune SA	01 Jan 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06489548 (Company_Website 1 \| Company_Website 2) Manual	Phase 2	Alzheimer Disease	1	intranasal foralumab	pcmqzosgqn(ugoqdpiaxl) = showing a marked reduction in microglia activation szfshftvuj (uuwznvmnou )	Positive	09 May 2025
NCT06802328 (GlobeNewswire) Manual	Not Applicable	Multiple Sclerosis, Secondary Progressive	10	Foralumab	lypuuiascl(ebhrmxqrkt) = None nqbqqoezum (hqfjcadaqi ) View more	Positive	06 May 2025
GlobeNewswire Manual	Not Applicable	Multiple Sclerosis, Secondary Progressive	-	Foralumab	isxfhaukfo(vroyfenthb) = xgqhuxvupx fmbdxpimhv (dgmxfpccku )	Positive	06 Jun 2024
GlobeNewswire Manual	Not Applicable	Multiple Sclerosis, Secondary Progressive	6	foralumab	pwvwvehxuj(xtanjswbyx) = cwjwrionnm keqzstkkwv (bvxxgpifqj ) View more	Positive	25 Apr 2024
GlobeNewswire Manual	Phase 2	Multiple Sclerosis	10	Foralumab	lgzlbxjwqd(bzypadjjym) = six out of eight Intermediate Size Patient Population Expanded Access (EA) patients have shown improvements in fatigue scores. PET scan findings showing a reduction in microglial activation was also seen in the six patients with MFIS score improvement at the three-month evaluation period. syryfrghup (sfvbkasgrq )	Positive	08 Jan 2024
NCT05029609 (Corporate Publications) Manual	Phase 1	Multiple Sclerosis, Secondary Progressive	2	Foralumab	knmmvjhawv(woxottldeo) = The patient showed clinically significant improvement on the Extended Disability Status Scale (EDSS) rheapxvgjf (bprwalxbcv )	Positive	20 Sep 2022

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