Isofol Medical AB (publ), (Nasdaq First North Premier: ISOFOL) today announced that the first patient in Japan has initiated treatment in the global Phase 3 AGENT study.
Isofol"™s drug candidate arfolitixorin is being evaluated in the first line of treatment of metastatic colorectal cancer (mCRC). The study is currently being conducted in the USA, Canada, Europe, Australia and now also in Japan. Isofol plans to start the trial in up to 15 clinics in Japan, in addition to the 80 clinics that are already open.
"A high pace is kept in our patient enrollment which enables the study"™s time frame to be achieved, especially given the significant unmet need for new treatment options in Japan and elsewhere," said Ulf Jungnelius, M.D., chief executive officer of Isofol. "This milestone brings us closer to our mission to improve the efficacy of standard of care and potentially benefit all patients with mCRC. We look forward working with the leading Japanese key opinion leaders and investigators who have shown great enthusiasm and dedication towards the AGENT study."
The AGENT study (ISO-CC-007) is expected to enroll 440 metastatic colorectal cancer (mCRC) patients, all treated in the first-line setting, who will receive either arfolitixorin or leucovorin, both in combination with 5-fluorouracil (5-FU), oxaliplatin and bevacizumab. The interim analysis is expected to start during the second half of 2020.