Drugs / Arfolitixorin
Arfolitixorin
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT06922383 | Apr 2025 → Nov 2028 expected | colorectal cancer | Isofol Medical AB | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04126655 | Feb 2020 → Oct 2021 | colorectal cancer | Vastra Gotaland Region | Unknown | No outcome recorded |
| Phase 1/2 | NCT02244632 | Sep 2014 → Jan 2020 | colorectal neoplasm | Isofol Medical AB | Completed | No outcome recorded |
| Phase 1/2 | NCT01987102 | Dec 2013 → Jan 2017 | osteosarcoma | Isofol Medical AB | Completed | No outcome recorded |
| Phase 1/2 | NCT01681472 | Sep 2012 → Aug 2013 | colonic neoplasm | Isofol Medical AB | Completed | Mixed |
| Phase 1/2 | NCT01397305 | Apr 2011 → Oct 2014 | rectal cancer | Isofol Medical AB | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT03750786 | Dec 2018 → Nov 2022 | colorectal cancer | Isofol Medical AB | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT03203564 Comparator | Jul → Aug 2017 | — | Isofol Medical AB | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 34
| Date | Issuer | Release |
|---|---|---|
| 2026-04-15 | Isofol Medical AB | Regulatory Isofol optimizes the design of its phase Ib/II study following new regulatory approval isofolmedical.com ↗
GOTHENBURG, Sweden, April 15, 2026 – Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL) today announces that the German regulatory authority BfArM has approved an optimized design for the company’s ongoing phase Ib/II study. |
| 2026-02-24 | Isofol Medical AB | Results Isofol provides update on the ongoing phase Ib/II clinical study of arfolitixorin isofolmedical.com ↗
All patients evaluated to date in the study have shown tumor shrinkage without dose-limiting side effects, and half of them have unexpectedly become candidates for tumor surgery during treatment. |
| 2025-09-30 | Isofol Medical AB | Results Isofol’s clinical study with arfolitixorin reaches another important milestone isofolmedical.com ↗
Following a meeting with the committee today, the second dose level at 200 mg/m2 is now considered safe and well-tolerated, and the company has received clearance to initiate the next level at 300 mg/m2. |
| 2025-03-21 | Isofol Medical AB | Regulatory Isofol receives regulatory approval to initiate clinical study of arfolitixorin isofolmedical.com ↗
Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), announces today that the regulatory authority in Germany, BfArM, has given their final approval for the initiation of the new clinical trial of the company’s drug candidate arfolitixorin. |
| 2025-01-27 | Isofol Medical AB | Results Isofol announces the presentation of a post-hoc analysis of the phase III study AGENT at the 2025 ASCO GI symposium isofolmedical.com ↗
These positive data, together with conclusions from earlier studies and analyses, add to the evidence platform and strengthen the outlook for the continued development of arfolitixorin. |
| 2024-11-21 | Isofol Medical AB | Results Isofol announces that an investigator-initiated study of arfolitixorin has been published in BJC Reports isofolmedical.com ↗
The results showed that giving arfolitixorin resulted in significantly higher concentrations of the active substance in liver metastatic tissue compared to the given dose of the standard of care treatment leucovorin. |
| 2024-11-11 | Isofol Medical AB | Results Isofol announces that an abstract has been accepted for presentation at ASCO GI 2025 isofolmedical.com ↗
The results show the importance of adherence to the study protocol and that a higher protocol compliance would likely increase the efficacy of arfolitixorin and thus, as previously communicated, support the company’s new development plan. |
| 2024-10-23 | Isofol Medical AB | Results A Late Breaking Abstract concerning arfolitixorin will be presented at ENA 2024 today isofolmedical.com ↗
The results show that arfolitixorin displays a potent, dose-dependent cytotoxic effect and increased activity in 5-FU-treated tumoroids that, at higher doses, is higher than with today’s standard treatmentleucovorin. |
| 2024-07-16 | Isofol Medical AB | Results Isofol announces new preclinical data supporting the previously communicated clinical development plan for arfolitixorin isofolmedical.com ↗
Both studies show that increased doses of arfolitixorin in combination with 5-FU lead to significantly higher efficacy. |
| 2024-07-05 | Isofol Medical AB | Results Isofol announces a post hoc per-protocol analysis of the AGENT study, further supporting arfolitixorin’s continued clinical development isofolmedical.com ↗
Results from the analysis, in which the expert committee excluded patients who were not treated in compliance with the study protocol, show a numerical difference in objective response rate (ORR) in favor of arfolitixorin (arfolitixorin: 59.3 % ORR; leucovorin: 51.5 % ORR; p<0.23). |
| 2023-12-07 | Isofol Medical AB | Results Isofol has received the first results from laboratory tests of arfolitixorin isofolmedical.com ↗
Data generated so far from the first experiments show no difference in additional effect of arfolitixorin compared to leucovorin. |
| 2023-07-04 | Isofol Medical AB | Results Isofol presents conclusions from the in-depth analysis of the AGENT study isofolmedical.com ↗
The results from the analysis support the hypothesis that a different dose and administration regimen has the potential to improve the efficacy of the company’s drug candidate arfolitixorin. |
| 2022-11-25 | Isofol Medical AB | Results Final data from the AGENT study confirms topline results isofolmedical.com ↗
Neither the primary endpoint of objective response rate (ORR) nor the key secondary endpoint of progression-free survival (PFS) were met. |
| 2022-09-07 | Isofol Medical AB | Results Isofol reports data from the AGENT study isofolmedical.com ↗
The P-value[2] for the primary endpoint of objective response rate (ORR) was approximately 0.85 and the study arms displayed no difference in outcome. |
| 2022-08-31 | Isofol Medical AB | Results Isofol provides update on the AGENT study isofolmedical.com ↗
Further analysis has also shown a preliminary indication of a non-significant detrimental trend in the endpoint of overall survival (OS) for the experimental arm of the study compared with the control arm. |
| 2022-08-03 | Isofol Medical AB | Results Isofol Announces Topline Results of Phase III AGENT Study – Did Not Meet Primary or Key Secondary Endpoints isofolmedical.com ↗ |
| 2021-12-03 | Isofol Medical AB | Regulatory Isofol Medical AB (publ) will not reach 300 PFS events in the AGENT study with current censoring rules based on FDA decision isofolmedical.com ↗
However, during a “Type C” meeting the FDA denied the request and will analyze the study results based on the original censoring rules for the primary analysis of PFS. |
| 2021-11-23 | Isofol Medical AB | Regulatory Isofol Medical AB (publ) receives FDA Fast Track Designation for arfolitixorin in advanced colorectal cancer (mCRC) isofolmedical.com ↗
the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the development of the Company’s lead drug candidate arfolitixorin |
| 2021-01-15 | Isofol Medical AB | Results Isofol to present gene expression results from the completed Phase I/IIa ISO-CC-005 study today at ASCO-GI 2021 and updates of the timing of the interim analysis in the AGENT study isofolmedical.com ↗
The poster present results from the ISO-CC-005 study where it was found that the gene expression levels of TYMS are significantly associated with clinical benefit (partial response or stable disease), in patients treated with 5-FU-based chemotherapy in combination with arfolitixorin. |
| 2020-09-30 | Isofol Medical AB | Results 55 % Overall Response Rate on the safety extension cohorts of the ISO-CC-005 Phase I/IIa study isofolmedical.com ↗
New data following 16-weeks of treatment and beyond shows best Overall Response Rate (ORR) of 55% in 31 patients. |
| 2020-03-30 | Isofol Medical AB | Results Gene expression data from new analysis method supports that a larger proportion of patients will benefit from arfolitixorin isofolmedical.com ↗
The data from the optimized gene expression method validated by TATAA Biocenter AB, compared with data based on the pre-commercial gene expression method, shows an increase of the proportion of patients having lower ABCC3 gene expression i.e. 66.6% to 75%. |
| 2019-11-18 | Isofol Medical AB | Regulatory Isofol to Expand Global Phase 3 AGENT Trial in First-Line Metastatic Colorectal Cancer to Australia isofolmedical.com ↗ |
| 2019-10-18 | Isofol Medical AB | Regulatory Isofol Receives Positive Feedback from PMDA in Japan, Expanding Ongoing Global Pivotal Phase 3 AGENT Trial in First Line Metastatic Colorectal Cancer isofolmedical.com ↗
today announced the successful completion of Japan’s Pharmaceutical and Medical Devices Agency (PMDA) review of the Clinical Trial Notification (CTN), allowing the start of the pivotal Phase 3 AGENT clinical study in metastatic colorectal cancer (mCRC) at Japanese sites. |
| 2019-05-08 | Isofol Medical AB | Results Isofol Reports 58 % Overall Response Rate in Patients with Metastatic Colorectal Cancer in Phase 1/2a Open Label Extension Study with arfolitixorin isofolmedical.com ↗
Preliminary response assessment data from 19 patients treated for 8-32 weeks showed a best overall response rate (ORR) in 58% of patients (11/19). |
| 2019-01-17 | Isofol Medical AB | Results Isofol Reports Early Tumor Shrinkage in Patients with Colorectal Cancer in Phase 1/2a Open Label Extension Study with arfolitixorin isofolmedical.com ↗
New results from 19 patients treated in the first-line setting showed early tumor shrinkage, defined as a greater than 20 % reduction in tumor size from baseline, in 47 % of patients (9/19) treated with the selected dose regimen, a combination of 120 mg/m² arfolitixorin and 5-fluorouracil (5-FU) with either irinotecan or oxaliplatin (ARFIRI/ARFOX). |
| 2018-05-03 | Isofol Medical AB | Regulatory Isofol reports FDAs feedback from the ongoing special protocol assessment (SPA) process isofolmedical.com ↗
In the feedback received from the FDA the company has reached a consensus with the FDA on the most important parameters for an SPA agreement and will now complete the SPA submission with the outstanding issues commented on by the FDA. |
| 2018-03-19 | Isofol Medical AB | Results Isofol Medical has selected arfolitixorin-dose for the phase III pivotal study ISO-CC-007 isofolmedical.com ↗
The results from the ISO-CC-005 study conducted in patients with metastatic colorectal cancer indicates that the arfolitixorin dose of 120 mg/m2 has the optimal safety and efficacy profile. |
| 2018-01-18 | Isofol Medical AB | Results Positive treatment results with Modufolin® (arfolitixorin) will be published at a cancer congress (ASCO) in the US isofolmedical.com ↗
A majority of the patients receiving an initial treatment (first line) of at least 60 mg/m2 Modufolin® (arfolitixorin) has responded to treatment. |
| 2018-01-17 | Isofol Medical AB | Regulatory Successful End-of-Phase 2 meeting with FDA and Phase 3 Program for Modufolin® agreed isofolmedical.com ↗
Consensus with the FDA was reached on the significant parameters for the phase III study set to support a New Drug Application (NDA) for Modufolin® (arfolitixorin) in metastatic colorectal cancer (mCRC). |
| 2018-01-11 | Isofol Medical AB | Results Isofol reports positive efficacy data for Modufolin® (arfolitixorin) from patients treated for metastatic colorectal cancer isofolmedical.com ↗
The data demonstrates continuous response to treatment between week 8 and week 16. |
| 2017-09-11 | Isofol Medical AB | Results Isofol announces that Modufolin® as a rescue therapy in the treatment of osteosarcoma in children is safe and preventive of HDMTX toxicities isofolmedical.com ↗
The results are the first for Modufolin® as a rescue therapy in the treatment of osteosarcoma |
| 2017-08-24 | Isofol Medical AB | Results From the ongoing ISO-CC-005 study, Isofol reports initial indications of efficacy of Modufolin® in patients with metastatic colorectal cancer isofolmedical.com ↗
Isofol Medical AB (publ), a clinical oncology company, announces that the initial indications of Modufolin® efficacy in the ISO-CC-005 study are encouraging and support execution of the planned pivotal efficacy study, ISO-CC-007. |
| 2017-01-24 | Isofol Medical AB | Regulatory FDA CLEARS ISOFOL’S IND APPLICATION TO START CLINICAL PROGRAM WITHIN COLORECTAL CANCER WITH MODUFOLIN® isofolmedical.com ↗
Isofol Medical AB announces that the US Food and Drug Administration (FDA) has cleared Isofol’s investigational new drug (IND) application and that the company has received a notice that the proposed clinical study with Modufolin® may proceed. |
| 2016-06-02 | Isofol Medical AB | Results ISOFOL MEDICAL HAS SUCCESSFULLY ADVANCED TO THE NEXT DOSE LEVEL OF MODUFOLIN® IN A PHASE I/II CLINICAL TRIAL IN COLORECTAL CANCER. isofolmedical.com ↗
12 patients have so far been evaluated after 8 weeks and according to the RECIST criteria all 12 patients have responded positively to the treatment. |
All press releases naming this drug 70 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Arfolitixorin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03750786 ↗ |
| Known as | 6R-MTHF | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01681472 ↗ |
| Known as | [6R]-5,10-methylene-tetrahydrofolate | “Arfolitixorin ([6R]-5,10-methylene-tetrahydrofolate) is an immediately active folate and may improve outcomes over the existing standard of care (leucovorin).” PMID 38059497 ↗ Jan 2024 |
| Known as | [6R]-5,10-methylenetetrahydrofolate ([6R]-5,10- MTHF) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1234270 ↗ |
| Known as | Arfolitixorina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1234270 ↗ |
| Known as | Arfolitixorine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1234270 ↗ |
| Known as | ISO-901 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1234270 ↗ |
| Known as | Modufolin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02244632 ↗ |
| Modality | Small molecule | — CHEMBL1234270 ↗ |
| Route | Intravenous | “10, 50, 100, 200, and 500 mg/m2 IV on day 1, day 8 day and day 15 of each 21-day cycle.” NCT01397305 ↗ |