Histopathologic image of colonic carcinoid stained by haematoxylin and eosin. Credit: KGH.

Isofol Medical has enrolled the first patient in the Phase III AGENT clinical study to investigate arfolitixorin for the treatment of metastatic colorectal cancer (mCRC).

Colorectal cancer occurs when cancer forms from the colon or rectum.

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The AGENT trial is designed to evaluate the safety and efficacy of arfolitixorin against leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab.

Isofol Medical chief medical officer Karin Ganlöv said: “We are now looking forward to quickly ramp up enrolment to meet the interest from participating hospitals and physicians.

“Arfolitixorin is an important new treatment option for patients since few new therapeutic agents have been introduced.”

“Arfolitixorin, which has shown promising efficacy and good safety, is an important new treatment option for patients since few new therapeutic agents have been introduced in 1st line treatment of mCRC the last decade.”

Isofol will conduct a blinded independent review of tumour response as part of the randomised, controlled, multi-centre trial,

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The company aims to enrol around 440 mCRC patients who will be randomised in 1:1 ratio to receive the study drugs.

Primary endpoint of the AGENT trial is overall response rate (ORR).

Its secondary endpoints include progression-free survival (PFS), duration of response (DOR), overall survival (OS) and number of curative metastasis resections.

The trial’s exploratory endpoints are assessment of pharmacokinetic (PK) and level of gene expression of folate relevant genes in tumour cells.

Isofol will conduct the trial at around 80 sites in the US, Canada and western Europe and is expected to provide top-line results in 2021.