Policy & Regulation
Isofol Medical AB begins treatment of first patient in Japan under Phase 3 AGENT Study of arfolitixorin
19 February 2020 -

Biotech company Isofol Medical AB (Nasdaq First North Premier:ISOFOL) revealed on Tuesday the start of dosing of the first patient with metastatic colorectal cancer (mCRC) under the global Phase 3 AGENT study in Japan.

The company added that the 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.

According to the company, it plans to start the trial in up to 15 clinics in Japan, in addition to the 80 clinics that are already open.

Arfolitixorin is the company's proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

This AGENT study is expected to enroll 440 metastatic mCRC patients in the first-line setting. The patients will receive either arfolitixorin or leucovorin, both in combination with 5-fluorouracil (5-FU), oxaliplatin and bevacizumab. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate. The interim analysis is expected to start during the second half of 2020, concluded the company.

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