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)

4,119

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

01 Jun 2025·Toxicology Reports

Bacillus clausii spores maintain gut homeostasis in murine ulcerative colitis via modulating microbiota, apoptosis, and the TXNIP/NLRP3 inflammasome cascade

Article

Author: Hammam, Olfat A ; El-Lakkany, Naglaa M ; Seif El-Din, Sayed H ; Salem, Maha B

Ulcerative colitis (UC), a persistent immune-mediated disorder lacking effective treatment, is distinguished by gut microbiota dysbiosis, abnormal activation of the NLRP3 inflammasome pathway, and apoptosis. Despite growing attention to these factors, understanding their significance in UC pathogenesis remains a challenge. The present study explores the potential therapeutic impact of Bacillus clausii (Bc) spores in a murine UC model induced by drinking 4 % (w/v) dextran sulfate sodium (DSS) in C57BL/6 mice. Subsequently, the DSS-induced mice were orally administered either Bc at varying concentrations (10⁵ and 10¹⁰ Colony forming unit, CFU) or sulfasalazine (SSZ) at a dosage of 200 mg/kg for 7 days. The disease-specific activity index (DAI) was calculated daily utilizing parameters such as body weight, diarrhea, and bloody stool. Changes in fecal Firmicutes and Bacteroidetes abundance, colonic TXNIP and NLRP3 contents, as well as colonic caspase-1, IL-1β, Bax, and Bcl-2 expression, were investigated. Additionally, markers related to oxidative stress and inflammation, histopathological changes and caspase-3 immunohistochemistry testing were conducted. DSS-treated mice had significantly higher DAI scores compared to controls, indicating severe colitis. However, SSZ treatment or Bc (10⁵ CFU) dramatically lowered DAI scores, with the highest Bc dosage (10¹⁰ CFU) producing the greatest improvement. Furthermore, Bc (10¹⁰ CFU) substantially (p < 0.05) boosted fecal Firmicutes while decreased Bacteroidetes, indicating reversal of gut dysbiosis. Bc effectively reduced colonic oxidative stress and inflammation by replenishing GSH and catalase and modulating the NF-κB, Nrf2/HO-1, and TXNIP/NLRP3 pathways. Additionally, Bc (10¹⁰ CFU) exhibited histologically almost normal mucosa, with maintained architecture and reduced apoptosis, as seen by normalization of Bcl2 and Bax with decreased caspase-3. Collectively, these findings point to the potential usefulness of Bc spores in preventing and treating DSS-induced colitis, positioning them as a promising candidate for UC management.

01 Mar 2025·Brain, Behavior, and Immunity

Early-life gut inflammation drives sex-dependent shifts in the microbiome-endocrine-brain axis

Article

Author: Yu, Huaxu ; Ciernia, Annie Vogel ; Deng, Brian D ; Clayton, Charlotte A ; Ghezzi, Hans ; Kim, Jennifer ; Voznyuk, Kateryna ; Arora, Sana ; Lee, Kristen ; Cotton, Sophie ; Singh, Ajay Paul ; Plett, Nadine ; Ng, Katharine M ; Yu, John-Paul J ; Sie, Claire ; Rosete, Cal ; Hamden, Jordan E ; Huan, Tao ; Carranza Garcia, Natalia A ; Tropini, Carolina ; Soma, Kiran K ; Sullivan, Olivia ; Choudhary, Jatin

Despite recent advances in understanding the connection between the gut microbiota and the adult brain, significant knowledge gaps remain regarding how gut inflammation affects brain development. We hypothesized that gut inflammation during early life would negatively affect neurodevelopment by disrupting microbiota communication to the brain. We therefore developed a novel pediatric chemical model of inflammatory bowel disease (IBD), an incurable condition affecting millions of people worldwide. IBD is characterized by chronic intestinal inflammation, and is associated with comorbid symptoms such as anxiety, depression and cognitive impairment. Notably, 25% of patients with IBD are diagnosed during childhood, and the effects of chronic inflammation during this critical developmental period remain poorly understood. This study investigated the effects of early-life gut inflammation induced by DSS (dextran sulfate sodium) on a range of microbiota, endocrine, and behavioral outcomes, focusing on sex-specific impacts. DSS-treated mice exhibited increased intestinal inflammation and altered microbiota membership, which correlated with changes in microbiota-derived circulating metabolites. The majority of behavioral measures were unaffected, with the exception of impaired mate-seeking behaviors in DSS-treated males. DSS-treated males also showed significantly smaller seminal vesicles, lower circulating androgens, and decreased intestinal hormone-activating enzyme activity compared to vehicle controls. In the brain, DSS treatment led to chronic, sex-specific alterations in microglial morphology. These results suggest that early-life gut inflammation causes changes in gut microbiota composition, affecting short-chain fatty acid (SCFA) producers and glucuronidase (GUS) activity, correlating with altered SCFA and androgen levels. The findings highlight the developmental sensitivity to inflammation-induced changes in endocrine signalling and emphasize the long-lasting physiological and microbiome changes associated with juvenile IBD.

15 Feb 2025·International Journal of Cancer

Ninjurin1 deficiency differentially mitigates colorectal cancer induced by azoxymethane and dextran sulfate sodium in male and female mice

Article

Author: Choi, Hoon ; Kim, Kyu‐Won ; Kim, Eun Hye ; Ha, Sungchan ; Choi, Soo In ; Jang, Jae Young ; Shin, Eun ; Song, Chin‐Hee ; Jeon, Sejin ; Kim, Nayoung ; Oh, Goo Taeg ; Nam, Ryoung Hee ; Seok, Yeong‐Jae

AbstractThis study investigated the role of Ninjurin1 (Ninj1), encoding a small transmembrane protein, in colitis‐associated colon tumorigenesis in relation to sex hormones. Male and female wild‐type (WT) and Ninj1 knockout (KO) mice were treated with azoxymethane (AOM) and dextran sulfate sodium (DSS), with or without testosterone propionate (TP). At week 2 (acute colitis stage), Ninj1 KO exhibited an alleviation in the colitis symptoms in both male and female mice. The M2 macrophage population increased and CD8+ T cell population decreased only in the female Ninj1 KO than in the female WT AOM/DSS group. In the female AOM/DSS group, TP treatment exacerbated colon shortening in the Ninj1 KO than in the WT. At week 13 (tumorigenesis stage), male Ninj1 KO mice had fewer tumors, but females showed similar tumors. In the WT AOM/DSS group, females had more M2 macrophages and fewer M1 macrophages than males, but this difference was absent in Ninj1 KO mice. In the Ninj1 KO versus WT group, the expression of pro‐inflammatory mediators and Ho‐1 and CD8+ T cell populations decreased in both female and male Ninj1 KO mice. In the WT group, M2 macrophage populations were increased by AOM/DSS treatment and decreased by TP treatment. However, neither treatment changed the cell populations in the Ninj1 KO group. These results suggest that Ninj1 is involved in colorectal cancer development in a testosterone‐dependent manner, which was different in male and female. This highlights the importance of considering sex disparities in understanding Ninj1's role in cancer pathogenesis.

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)

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KEGG	Wiki	ATC	Drug Bank
D02047	-	-	-

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Stem cell mobilisation	Phase 3	SE	TikoMed AB	-
Pancreatitis, Chronic	Phase 2	SE	TikoMed AB	15 Jul 2022
Glaucoma	Phase 2	SE	TikoMed AB	-
Rejection of pancreas transplant	Phase 2	-	University of Uppsala	-
Stroke	Phase 2	SE	TikoMed AB	-
Hematologic Neoplasms	Phase 1	-	University of Uppsala	-
Diabetes Mellitus, Type 1	Preclinical	SE	TikoMed AB	08 Feb 2021
Diabetes Mellitus, Type 1	Preclinical	NO	TikoMed AB	08 Feb 2021
Diabetes Mellitus, Type 1	Preclinical	NL	TikoMed AB	08 Feb 2021
Amyotrophic Lateral Sclerosis	Preclinical	SE	TikoMed AB	15 Aug 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


DDW2023	Not Applicable	-	-	Dextran sulfate sodium (Control rats)	jprlswzmmr(kjpiheoqzr) = reduced by 33% in DSS-treated male and female rats khcajmfsve (ptcudiuwxv ) 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)	vldntaqsqa(kgytjopnsz) = dariskixey wlvtsixwyp (ddptgocscs )	Positive	01 Apr 2010

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Dextran sulfate sodium(TikoMed AB)

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