Isofol Medical AB provided an update on the extension study portion of the ISO-CC-005 Phase I/IIa study. New data following 16-weeks of treatment and beyond shows best Overall Response Rate (ORR) of 55% in 31 patients. The results are in line with the targeted readout in the ongoing global Phase III study, AGENT. The new data comes from the two safety extension cohorts of 31 evaluable patients who have been followed and evaluated with CT-scans after 16 weeks or longer, to analyze the exploratory endpoint best ORR - defined as percentage of patients whose disease decreased more than 30% and/or disappears after treatment - which is the primary endpoint in the AGENT-study. Out of the 31 patients, 17 were treated with an ARFOX regimen, which is the experimental regimen in the ongoing AGENT-study. A best ORR of 59% was observed in the ARFOX regimen group versus 50% in the ARFIRI regimen group, despite a high frequency of right-sided tumor location and BRAF mutation, both being poor prognostic factors for response. In total, the data resulted in a best ORR of 55 %. The ISO-CC-005 Phase I/IIa study was completed in January 2020 and included totally 105 patients between dose finding cohorts (62 patients) and two safety extension cohorts (43 patients). The extension phases include a similar target population, as in the AGENT-study in the first-line setting, to evaluate safety and efficacy at eight weeks on the selected dose regimen of arfolitixorin (120 mg/m[2]). After the eight weeks of the main study the investigators could decide to either terminate the patient's participation or continue treatment and evaluate patients beyond eight weeks (not mandated).