Isofol has completed a Phase I/IIa study, ISO-CC-005, which evaluated the safety and efficacy of arfolitixorin in patients with mCRC. The main purpose was to establish a safe and effective dose for future studies and clinical practice. The dose definition part of the study was completed in March 2018.
After selected 120 mg of arfolitixorin/m² as a recommended study dose (RP2D), the study was expanded with an additional treatment group of 11 patients treated with the dosing regimen, arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab, which is now used in the enrolling AGENT study. Patient data from these 11 patients showed a positive safety profile for the treatment regimen, which was a requirement from the FDA to initiate the global phase III study, AGENT.
Isofol started in 2018 two additional treatment groups (safety extension cohort I and II) to generate more safety and efficacy data. The goal was to recruit at least 40 mCRC patients in the first line treatment (initial treatment), who for at least 8 weeks received treatment with arfolitixorin in combination with 5-FU and oxaliplatin or in combination with 5-FU and irinotecan. Patients were evaluated for safety and efficacy by measuring side effects and tumor shrinkage.
The completion of the 005-study was announced in January 2020. In total, 105 patients were included in the study.