Overview clinical studies
The drug candidate arfolitixorin is a direct-acting folate that does not require metabolic conversion in the body. Studies have shown that arfolitixorin therefore achieves higher concentrations of active folate in tumor tissue compared to existing folate therapies, and clinical data demonstrate promising efficacy and safety.
Clinical studies in colorectal cancer
| NCT ID | Research | Preclin | Phase I | Phase II | Phase III |
|---|
| 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 >> | |
| 03750786 | AGENT ISO-CC-007, Phase III. Pivotal study in which 490 patients were treated for metastatic colorectal cancer (mCRC) in first-line*. Clinical Trial >> | |
| 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 >> | |
| 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 >> | |
| 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 >> |
* 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 since 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.
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