First patient enrolled in Isofol’s Pivotal Phase 3 AGENT study in 1st line metastatic colorectal cancer

GOTHENBURG, Sweden, December 18, 2018 – Isofol Medical AB (publ), (Nasdaq First North Premier: ISOFOL) today announced that the first patient has been enrolled in the pivotal Phase 3 AGENT clinical study evaluating arfolitixorin for the treatment of metastatic colorectal cancer (mCRC). AGENT is a randomized, controlled, multi-centre study with blinded independent review of the tumour response.     AGENT (ISO-CC-007) will enrol approximately 440 mCRC patients, aged 18 years or over, to receive arfolitixorin or leucovorin, both in combination with 5-FU, oxaliplatin and bevacizumab. The primary endpoint is Overall Response Rate (ORR) and the key secondary endpoints are Progression Free Survival (PFS) and Duration Of Response (DOR). Top-line data from the study is expected 2021.

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