Isofol has an ongoing Phase IIa study, ISO-CC-005, which evaluate the safety and efficacy of arfolitixorin in patients with mCRC. The main purpose is 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 selecting 120 mg of arfolitixorin/m² as a continued study dose, 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 3 study, AGENT.
Isofol has since started two additional treatment groups 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 receive treatment with arfolitixorin in combination with 5-FU and oxaliplatin or in combination with 5-FU and irinotecan. Patients will be evaluated for safety and efficacy by measuring side effects and tumor shrinkage. Recruitment and treatment of patients is ongoing in a total of 8 hospitals in the Nordic countries and Europe and all 40 patients have been recruited and initiated treatment.
In total, 105 patients have started treatment in the study.