Overview 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 new dosage regimens 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.
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All clinical studies
| NCT ID | Â | Research | Preclin | Phase 1 | Phase 2 | Phase 3 |
|---|
| Â | Colorectal Cancer | Â |
| Study design phase | ISO-CC-010, Phase Ib/II. Arfolitixorin in combination with 5-FU-based cytostatic therapies in treatment-naive mCRC patients. |
Design
|
| 03750786 | AGENT
ISO-CC-007, Phase III. Pivotal study in which 490 patients were treated for metastatic colorectal cancer (mCRC) in first-line*. |
Stopped
|
| 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. |
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. |
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. |
Completed
|
| Â | Osteosarcoma.
| Â |
| 02383901 | ISO-MTX-OB1, A Retrospective Non-intervention Study tto investigate how rescue treatment with folates in patients with osteosarcoma works in clinical context. |
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. |
Completed
|
Â
*
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 01-30-2025
