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All about the drug candidate arfolitixorin
and related information

Summary clinical studies

All clinical studies

NCT ID ResearchPreclinPhase 1Phase 2Phase 3
 Colorectal Cancer 
ISO-CC-007, Phase III. Pivotal study in which 490 patients were treated for metastatic colorectal cancer (mCRC) in first-line*. Clinical Trial >>
01681472ISO-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 >>
01397305ISO-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 >>
02244632ISO-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 >>
02383901ISO-MTX-OB1, A Retrospective Non-intervention Study tto investigate how rescue treatment with folates in patients with osteosarcoma works in clinical context. Clinical Trial >>
01987102ISO-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 >>
At the end of 2022, it was determined that the AGENT study did not achieve the goals agreed with the pharmaceutical authorities. The company believes that further analyses of the extensive data generated in the Phase III study may provide 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. Isofol is also evaluating various opportunities to conducting additional studies.

Last updated 12-14-2023

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