This is a Phase II open, randomized, active comparator-controlled multi center study in patients with severe type-1 diabetes. This is a two-armed study where patients are randomized in a 2:1 ratio between IBsolvMIR and heparin. Eighteen patients are planned to be included.
The study consists of up to 8 visits; screening, transplantation surgery with bolus administration of study drug or active comparator, IBsolvMIR doses on day 1, 3 and 6 after surgery, follow up visits on day 7 and 14, and follow-up phone call on day 44.
The primary endpoint is to study AEs up to 44 days following study drug administration. The secondary endpoints are to evaluate changes in TAT, C-peptide, C3a and HGF at baseline and during the first 24 hours after study drug administration, as well as evaluate a change in levels of C-peptide-glucose-creatinine ratio on day 14 compared to baseline.

Start Date08 Feb 2021

Sponsor / Collaborator

TikoMed AB

NCT03705390

/ CompletedPhase 2IIT

A Phase II Pilot Single-arm Safety and Tolerability Study of ILB in Patients With Motor Neurone Disease (MND)/ Amyotrophic Lateral Sclerosis (ALS)

This is a phase II study to determine the safety and tolerability of ILB , a type of low molecular weight dextran sulfate, in patients with Motor Neurone Disease (MND)/ Amyotrophic Lateral Sclerosis (ALS)

Start Date29 Mar 2019

Sponsor / Collaborator

University of Birmingham

[+3]

NCT03613571

/ TerminatedPhase 2

A Single-centre, Open Single-arm Study Where the Safety, Tolerability and Efficacy of Subcutaneously Administered ILB Will be Evaluated in Patients With Amyotrophic Lateral Sclerosis

This is a Phase 2a single-centre, open single-arm study in patients with Amyotrophic Lateral Sclerosis (ALS) of intermediate progression rate. Eligible subjects will be administered weekly doses of ILB. A total of 5 subcutaneous (s.c.) doses will be administered at the study clinic.
The study consists of 10 visits; One 2-part screening visit, 5 ILB administration visits, and 3 follow-up visits. Each individual patient's study participation will be 4 months, including the screening and follow-up visits. Fifteen patients are planned to be included.
The primary objective of the study is to evaluate the safety and tolerability of ILB in patients diagnosed with ALS.
ILB is a solution for subcutaneous (s.c.) injection in saline solution. The dose administered will depend on the subject's body weight at the second study visit, prior to the first ILB administration.
No formal sample size calculation has been performed for this study. The proposed sample size is considered sufficient in this early phase 2 development to provide adequate information on the patients. Categorical data will be presented as counts and percentages. Continuous data will be summarised using descriptive statistics.

Start Date15 Aug 2018

Sponsor / Collaborator

TikoMed AB

100 Clinical Results associated with Dextran sulfate sodium(TikoMed AB)

100 Translational Medicine associated with Dextran sulfate sodium(TikoMed AB)

100 Patents (Medical) associated with Dextran sulfate sodium(TikoMed AB)

2,286

Literatures (Medical) associated with Dextran sulfate sodium(TikoMed AB)

01 May 2025·PHYTOMEDICINE

Qi-Huang decoction alleviates DSS-induced colitis with Candida albicans dysbiosis by enhancing innate immune response through Dectin-1-associated signaling

Article

Author: Shao, Jing ; Wang, Zixu ; Luo, Qinai ; Wu, Daqiang ; Wang, Changzhong ; Zhu, Hanyu ; Wang, Tianming ; Yang, Liu ; Liu, Chengcheng ; Hu, Min

BACKGROUND:

Ulcerative colitis (UC) is a chronic inflammatory disease of the gastrointestinal tract. Candida albicans, a common commensal fungus in the human gut, has been increasingly implicated in UC pathogenesis. Qi-Huang decoction (QHD), a traditional Chinese herbal formula known for its spleen-invigorating and purgative properties, is commonly used to restore gastrointestinal function.

PURPOSE:

This study investigates the therapeutic potential of QHD in treating colitis exacerbated by C. albicans and explores the underlying mechanisms of action.

METHODS:

A mouse model of colitis was induced using dextran sulfate sodium combined with gavage of C. albicans. Following QHD treatment, colitis severity was evaluated by measuring survival rate, body weight, disease activity index, colon length, and fungal burden, and through histopathological analysis using hematoxylin-eosin staining. The expression of proinflammatory genes IL-1β and TNF-α was quantified, alongside protein levels of key molecules involved in Dectin-1 signaling, including Syk, CARD-9, NLRP-3, Raf-1, and NF-κB. Barrier integrity markers, such as Occludin and Claudin-1, were also examined. To further elucidate QHD's mechanisms, Dectin-1 was inhibited using laminarin. In vitro experiments assessed QHD's antifungal activity against three Candida strains through microdilution, spot assays, and time-kill tests. RAW 264.7 macrophages were employed to study the exposure of fungal cell wall β-glucan and subsequent phagocytosis. Molecular docking simulations predicted interactions between QHD's active compounds and the Dectin-1 receptor.

RESULTS:

QHD significantly mitigated colitis severity and reduced fungal burden in vivo. QHD enhanced β-glucan exposure on the fungal cell wall, thereby stimulating phagocytosis by RAW264.7 macrophages. QHD effectively activated Dectin-1-mediated signaling pathways and increased proinflammatory levels in RAW 264.7 cells. In colitis mice, QHD treatment markedly reduced inflammation and Dectin-1 signaling following fungal clearance. However, Dectin-1 inhibition with LAM neutralized QHD's therapeutic effects, highlighting the pathway's importance in mediating QHD's efficacy. Interestingly, QHD alone elevated Dectin-1, NF-κB, TGF-β, and IL-10 levels, whereas reduced IL-1β and TNF-α expression, suggesting a dual modulatory role in inflammation. Molecular docking confirmed a potential direct interaction between QHD's bioactive components and the Dectin-1 receptor.

CONCLUSION:

QHD demonstrates promising therapeutic potential for managing Candida colitis by modulating immune responses and targeting Dectin-1 signaling pathways in clinical settings.

01 May 2025·INTERNATIONAL IMMUNOPHARMACOLOGY

Human antigen R -mediated autophagy-related gene 3 methylation enhances autophagy-driven ferroptosis in Crohn's disease colitis

Article

Author: Dong, Kai ; Wang, Shikai ; He, Di ; Li, Zhipeng ; Chang, Yunxiang ; Zhang, Hongzhen

BACKGROUND AND AIMS:

Crohn's disease (CD) is a chronic inflammatory disorder that can affect any part of the gastrointestinal tract, with the exact etiology remaining unclear. Recent studies have implicated the role of human antigen R (HuR) in the pathogenesis of various inflammatory diseases, including CD. However, the role of HuR in the modulation of CD remains underexplored. Therefore, this study aimed to investigate the mechanistic involvement of HuR in CD.

METHODS:

We established colitis models using human intestinal epithelial cells and lipopolysaccharide and dextran sulfate sodium-induced mice. Additionally, by knocking out HuR in both cell and animal models, we validated the role of HuR in autophagy and ferroptosis. The role of HuR in regulating ferroptosis accompanied by autophagy activation in CD was detected using ELISA, flow cytometry, immunofluorescence, transmission electron microscopy, Western blot, and RT-qPCR. The demethylation level of ATG3 and the stability of ATG3 mRNA regulated by HuR were detected using immunofluorescence, RIP, and MeRIP-qPCR. The effect of HuR on DSS-induced colitis was evaluated using DAI score, H&E staining, TUNEL staining, and immunohistochemistry.

RESULTS:

The results show that HuR expression is significantly increased in CD colonic inflammation. Compared with the control group, the model group mice exhibited decreased levels of lipid peroxidation markers glutathione and superoxide dismutase, elevated malondialdehyde and reactive oxygen species levels, and reduced expression of iron-related proteins glutathione peroxidase 4, ferritin heavy chain protein 1, and solute carrier family 7 member 11. Additionally, the expression of autophagy-related proteins microtubule-associated protein 1 A/1B-light chain 3, beclin-1, and autophagy related 3 (ATG3) was upregulated, while p62 expression was downregulated. In both in vitro and in vivo models, HuR knockout reversed these changes induced by lipopolysaccharide and dextran sulfate sodium, concomitant with improved tissue pathology. Mechanistically, HuR enhances autophagy-mediated ferroptosis in CD colonic inflammation by regulating ATG3 methylation and mRNA stability.

CONCLUSION:

HuR accelerates colonic inflammation in CD by regulating ATG3 methylation, which enhances autophagy-mediated ferroptosis. Knockout of HuR alleviates Crohn's colitis. This finding provides a potential therapeutic target for the treatment of CD.

10 Apr 2025·INFLAMMATORY BOWEL DISEASES

Winnie Mice: A Chronic and Progressive Model of Ulcerative Colitis

Review

Author: Verna, Giulio ; Chieppa, Marcello ; De Santis, Stefania

Abstract:

Recent trends show a continuous worldwide rise in the incidence of ulcerative colitis (UC), leading to increased interest in its etiology and pathogenesis, which is currently unknown. To gain a better mechanistic understanding of this disease, many mouse models have been developed over the last several years, with variations of dextran sodium sulfate administration representing the most widely employed. The Winnie mouse strain was created through elicited random mutations in Muc2, resulting in a progressive, chronic intestinal inflammation localized to the colon that worsens over time. Moreover, Winnie mice display immunologic and microbiota features that are similar to those that can be found in UC patients. Phenotypically, the presence, albeit rare, of rectal prolapse and other complications impacting quality of life can be observed in Winnie mice, as well as extraintestinal manifestations that are often associated with UC. While Winnie mice are currently less studied compared to other more established models of colitis, much has been discovered in the initial years of its use as a UC-like model. In summary, the use of Winnie mice adds to the growing armamentarium that is required to develop precision-based medicine for its future application in treating complex multifactorial diseases, such as UC.

News (Medical) associated with Dextran sulfate sodium(TikoMed AB)

28 Apr 2023

·www.globenewswire.com

Polydex Pharmaceuticals Limited and BioSpectra Inc. Announce Business Combination

Polydex Pharmaceuticals Limited (OTC Pink: POLXF) (the “Company” or “Polydex”) announced today that it has entered into a Plan of Arrangement agreement (the “Arrangement Agreement”) whereby BioSpectra, Inc. and BioSpectra Canada, Ltd (together, “BioSpectra”) will acquire all of the outstanding common and preferred shares of the Company for total consideration of $6,940,000, of which US$6,924,980.02 will be paid for 3,432,478 common shares outstanding and US$15,019.98 will be paid for 899,400 Class B Preferred shares outstanding. The price per common share is US$2.017. Under the Arrangement Agreement the transaction will be effected pursuant to a statutory plan of arrangement (the “Arrangement”) under section 182 of the Ontario Business Corporations Act (the “OBCA”). The Arrangement will result in each issued and outstanding share of Polydex being deemed transferred to BioSpectra by each Polydex shareholder, without any further act or formality on the part of the Polydex shareholder, and each Polydex shareholder shall receive the Consideration in exchange for their shares. The Board of Directors of the Company has received a fairness opinion from Evans & Evans, Inc., an independent consultant that provides business valuations. The fairness opinion supports the terms of the Arrangement and the Consideration as fair to the Company’s shareholders. The Board has approved the Arrangement and the Arrangement Agreement. The Company will seek an interim order approving the deal from the Ontario Court of Justice. Following receipt of a favorable interim order, the Company will call a meeting of shareholders to obtain shareholder approval. Shareholders will receive a Notice of Meeting and Information Circular prior to such meeting. The Board of the Company unanimously recommends approval of the transaction. If the Arrangement is approved by shareholders at the shareholder meeting, the Company will then seek a final order from the Ontario Court of Justice approving the Arrangement and authorizing its closing. George Usher, the President and CEO of Polydex commented that “We are extremely pleased with the transaction we have struck with BioSpectra. This transaction comes as a conclusion to a long process undertaken by the Board to enhance shareholder value. We have studied multiple options and believe this is the best one for our shareholders.” Polydex, based in Toronto, Ontario, is engaged in the manufacturing of bulk pharmaceutical intermediates for the worldwide veterinary pharmaceutical industry and also the development, manufacturing and marketing of biotechnology-based products for the human pharmaceutical market. The Company focuses on the manufacture and sale of Dextran and derivative products, including Iron Dextran and Dextran Sulphate and other specialty chemicals. The Company conducts its business operations through its two wholly-owned subsidiaries/divisions. The manufacture and sale of Dextran and derivative products is conducted through Dextran Products and Chemdex Inc. which is incorporated in the State of Kansas, United States. The content above comes from the network. if any infringement, please contact us to modify.

13 Sep 2022

·www.prnewswire.com

TikoMed's ILB® inhibits cell infection by coronaviruses and modulates reactive cytokine release from microglia in vitro

Adds further support for its broad-spectrum mechanism of action following other recent TBI, ALS and tropical virus studies VIKEN, Sweden, Sept. 13, 2022 /PRNewswire/ -- TikoMed today announced the inclusion in bioRxiv* of an in vitro study evaluating the ability of the company's lead drug candidate ILB® to: inhibit infection of human cells by the NL63 coronavirus assessed by immunofluorescence of viral particles; and directly block the interaction of the SARS-CoV-2 viral spike protein with the ACE2 receptor; and modulate the downstream consequences of viral infection including the reactive cytokine release from human microglia induced by various SARS-CoV-2 variant spike proteins. The study shows that ILB® blocked ACE2:spike protein interaction and inhibited coronaviral infection. ILB® also attenuated the omicron-induced release of pro-inflammatory cytokines, including TNFa, from human microglia, indicating control of post-viral neuroinflammation. "This work extends our findings of ILB®'s antiviral impact upon flavivirus infections to now include coronavirus. Furthermore, we are excited to have uncovered a potential molecular mechanism for these findings by showing that ILB® inhibited SARS-CoV-2 spike protein interacting with ACE2, the key docking site for SARS-CoV-2 to gain entry to human cells," said Professor Ann Logan PhD (Professor of Regenerative Medicine & CSO, Axolotl Ltd). Professor Nicholas Barnes PhD PBPhS (Professor of Pharmacology & CEO, Celentyx Ltd) also commented: "In pathological post-viral fatigue syndromes such as long COVID, a key brain cell called microglia appear overactive and promote the associated neuroinflammation. This data showed that activated microglia are calmed by ILB® in vitro and suggests ILB® has the potential to inhibit neuroinflammation and hence improve symptoms of patients with conditions such as long COVID." TikoMed recently announced the publication of a peer-reviewed article on the mode of action of ILB®. In multiple preclinical and clinical studies across a variety of neuroinflammation-driven diseases. ILB® both mobilized and modulated naturally occurring tissue repair mechanisms, released heparin-binding growth factors, and restored cellular homeostasis and function, . Additionally, TikoMed has reported that ILB® inhibited infection of human cells by Dengue, Zika and Yellow Fever viruses in vitro, . Media: International: Richard Hayhurst [email protected] or +44 7711 821527 Nordics: Ola Bjorkman [email protected] or +46 70 245 7497 About Corona viruses Coronaviruses are a large family of enveloped, positive-stranded RNA pathogenic viruses that cause infectious disease in animals and humans. For example, the highly transmissible SARS-CoV-2 virus causes coronavirus disease (COVID-19) which causes a mild to moderate respiratory disease in most humans, but susceptible individuals can become dangerously ill, developing severe acute respiratory syndrome (SARS) and acute respiratory distress syndrome (ARDS) that can result in organ damage[1]. The global pandemic of COVID-19 disease that has spread since 2019 has had devastating health, social and economic consequences that remain burdensome[2]. By August 2022 that World Health Organisation report 599,825,400 confirmed cases of COVID19 and 6,469,458 confirmed deaths (), representing just over 1% of those infected. *bioRxiv is a free online archive and distribution service for unpublished preprints in the life sciences. It is operated by Cold Spring Harbor Laboratory, a not-for-profit research and educational institution. By posting preprints on bioRxiv, authors are able to make their findings immediately available to the scientific community and receive feedback on draft manuscripts before they are submitted to journals. For full study details on "A clinical stage LMW-DS drug inhibits cell infection by coronaviruses and modulates reactive cytokine release from microglia," please access the publication: . [1]Mistry P, Barmania F, Mellet J, Peta K, Strydom A, Viljoen IM, James W, Gordon S, Pepper MS. SARS-CoV-2 Variants, Vaccines, and Host Immunity. Front Immunol. 2022 Jan 3;12:809244. doi: 10.3389/fimmu.2021.809244. PMID: 35046961; PMCID: PMC8761766. [2]Koelle K, Martin MA, Antia R, Lopman B, Dean NE. The changing epidemiology of SARS-CoV-2. Science. 2022 Mar 11;375(6585):1116-1121. doi: 10.1126/science.abm4915. Epub 2022 Mar 10. PMID: 35271324; PMCID: PMC9009722 CONTACT: Contact: [email protected] or +46 42 23 84 40 This information was brought to you by Cision SOURCE Tikomed

Vaccine

07 Sep 2022

·www.prnewswire.com

TikoMed's drug candidate ILB® inhibited infection of human cells by Dengue, Zika and Yellow Fever viruses in vitro, providing further support for its broad spectrum mechanism of action

VIKEN, Sweden, Sept. 7, 2022 /PRNewswire/ -- TikoMed today announced the inclusion in bioRxiv* of an in vitro study examining the ability of the company's lead drug candidate ILB® to inhibit infection of human cells by four serotypes of Dengue virus (DENV1-4), two strains of Zika virus (African and Asian) and Yellow Fever virus (vaccine strain YF17D) assessed by immunofluorescence of viral particles. In the study, ILB® potently inhibited infection by all the strains of Dengue, Zika and Yellow Fever virus in a concentration-dependent manner with IC50 for ILB® ranging from 31 to 343 μg/ml. Professor Nicholas Barnes PhD PBPhS (Professor of Pharmacology & CEO, Celentyx Ltd, and one of the world's most highly cited researchers ) commented: "It is well recognised that infection by flaviviruses like Dengue, Zika and Yellow Fever virus can lead to catastrophic life-threatening conditions. This emphasises the clinical need for safe and effective medicines to treat these infections. What I find particularly exciting about these results is the effects observed at ILB® concentrations that have been achieved in humans following doses that have been well tolerated. These findings offer hope to the millions of patients that continue to be devastated by flavivirus infections." TikoMed recently announced the publication of a peer-reviewed, scientific article on the mode of action of ILB®. In multiple preclinical and clinical studies across a variety of neuroinflammation-driven diseases. ILB® both mobilized and modulated naturally occurring tissue repair mechanisms, released heparin-binding growth factors, and restored cellular homeostasis and function. "These results provide further evidence of the anti-viral potential and unique broad spectrum mechanism of action of TikoMed's ILB® drug platform. We have already initiated clinical development programs for Amyotrophic Lateral Sclerosis (ALS), Traumatic Brain Injury (TBI) and islet cell transplantation and plan to consider additional evaluation in other diseases," said Anders Kristensson, CEO of TikoMed. *bioRxiv is a free online archive and distribution service for unpublished preprints in the life sciences. It is operated by Cold Spring Harbor Laboratory, a not-for-profit research and educational institution. By posting preprints on bioRxiv, authors are able to make their findings immediately available to the scientific community and receive feedback on draft manuscripts before they are submitted to journals. For full study details on "A clinical stage LMW-DS drug inhibits infection of human cells by Dengue, Zika and Yellow Fever viruses", please access the publication: . About flaviviruses Flaviviruses are responsible for the most abundant arboviral diseases of humans in terms of geographical distribution, morbidity and mortality; at least 2.5 billion people are at risk with, for example, an estimated 100-400 million Dengue infections a year. However, for infections by Dengue, Zika or Yellow Fever virus there are no effective anti-infective drug treatments nor for Dengue or Zika virus a safe effective vaccine and prevention at present focusses on vector (mosquito) control. Whilst symptoms from Dengue, Zika and Yellow Fever virus infection may be mild for some, they are very serious and life threatening for others. For instance, severe Dengue is a leading cause of hospitalisation and death among children and adults in Asian and Latin American countries. Likewise, Zika infection can have catastrophic consequences for pregnant women following the passing of the virus to their foetus with arising miscarriage or birth defects including microcephaly that can be fatal. CONTACT: Contact: [email protected] or +46 42 23 84 40 Media: International: Richard Hayhurst [email protected] or +44 7711 821527 Nordics: Ola Bjorkman [email protected] or +46 70 245 7497 This information was brought to you by Cision SOURCE Tikomed

Vaccine

100 Deals associated with Dextran sulfate sodium(TikoMed AB)

External Link

KEGG	Wiki	ATC	Drug Bank
D02047	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pancreatitis, Chronic	Phase 2	Sweden	TikoMed AB	15 Jul 2022
Diabetes Mellitus, Type 1	Phase 2	Netherlands	TikoMed AB	08 Feb 2021
Diabetes Mellitus, Type 1	Phase 2	Norway	TikoMed AB	08 Feb 2021
Diabetes Mellitus, Type 1	Phase 2	Sweden	TikoMed AB	08 Feb 2021
Amyotrophic Lateral Sclerosis	Phase 2	Sweden	TikoMed AB	15 Aug 2018
Rejection of pancreas transplant	Phase 2	Sweden	-	04 Mar 2009
Hematologic Neoplasms	Phase 1	-	University of Uppsala	-
Stem cell mobilisation	Phase 1	Sweden	TikoMed AB	-
Brain Injuries, Traumatic	Preclinical	Sweden	TikoMed AB	-
Glaucoma	Preclinical	Sweden	TikoMed AB	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


DDW2023	Not Applicable	-	-	Dextran sulfate sodium (Control rats)	pzqxpnpads(uxvuaezbkb) = reduced by 33% in DSS-treated male and female rats jgoqsujzrd (yoftqorjzw ) View more	-	06 May 2023
DDW2023	Not Applicable	-	-	DSSDextran sulfate sodium (DSS-treated rats)		-	06 May 2023
NIH P01DK043785 (ARVO2010)	Not Applicable	Inflammation	-	Dextran Sodium Sulfate (Control mice)	hqrihulflx(yllqckdczh) = bmwhougbjw cyiqixfjdv (krjdxivwsd )	Positive	01 Apr 2010

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Dextran sulfate sodium(TikoMed AB)

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