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All about the drug candidate arfolitixorin
and related information

Summary clinical studies

Isofol works to improve the quality of life and prognosis for patients with severe forms of cancer. The company’s drug candidate arfolitixorin aims to increase the effect of first-line standard treatment for several forms of solid tumors and is currently being studied in colorectal cancer, the world’s third most common cancer, where the medical need for better treatments is truly urgent.

A Phase Ib/II study is now being conducted with a new dosage regimen that are expected to optimize the drug candidate’s efficacy, after the company’s global Phase III study, AGENT, did not achieve the regulatory requirements at the end of 2022.

Read more about the company’s clinical development plan >>

All clinical studies

NCT ID   Research Preclin Phase 1 Phase 2 Phase 3
  Colorectal Cancer  
06922383 ISO-CC-010, Phase Ib/II. Arfolitixorin in combination with 5-FU-based cytostatic therapies in treatment-naive mCRC patients. Clinical Trial >>
On-going
  AGENT*
ISO-CC-007, Phase III. Pivotal study in which 490 patients were treated for metastatic colorectal cancer (mCRC) in first-line. Clinical Trial >>
Closed
01681472 ISO-CC-002, a Phase I/II Pharmacockinetics and pharmacodynamics clinical investigation of arfolitixorin (Modufolin®) in Plasma, Tumor and Adjacent Mucosa in Patients with Colon Cancer. Clinical Trial >>
Completed
01397305 ISO-MC-091, Phase I/II Study where Pemetrexed is co-administered with arfolitixorin (Modufolin®) to newly diagnosed, non-cytostatically-treated patients with resectable Rectal Cancer. Clinical Trial >>
Completed
02244632 ISO-CC-005, Phase I/II arfolitixorin (Modufolin®) in Combination with 5-Fluorouracil Alone or with Irinotecamn or Oxaliplatin ± bevacizumab in patients with colorectal cancer. Clinical Trial >>
Completed
  Osteosarcoma.
  
02383901 ISO-MTX-OB1, A Retrospective Non-intervention Study tto investigate how rescue treatment with folates in patients with osteosarcoma works in clinical context. Clinical Trial >>
Completed
01987102 ISO-MTX-003, Phase I/II study intended to identify the arfolitixorin (Modufolin®) dose to be used in continued clinical development for in the osteosarcoma indication. Clinical Trial >>
Completed
 
* At the end of 2022, it was determined that the AGENT study did not achieve the goals agreed with the pharmaceutical authorities. The company has now conducted in-depth analyses of the extensive data generated in the phase III study, AGENT, which provided greater clarity on possible reasons why arfolitixorin did not show a statistically significant difference in efficacy compared to the current standard of care in the study. 

Last updated 04-28-2025

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