The recruitment is in line with the regulatory conditions by the Japanese Medicines Agency, PMDA, to obtain marketing approval in the country.
Arfolitixorin needs no complex metabolic activation to be effective and is being developed to boost the standard of care chemotherapy’s efficacy for treating advanced colorectal cancer.
The randomised, controlled, multi-centre Phase III AGENT trial is evaluating the efficacy and safety of arfolitixorin versus leucovorin, both given along with Fluorouracil (5-FU), oxaliplatin and bevacizumab.
Overall response rate is the primary endpoint while key secondary endpoints of the study are progression-free survival and duration of response.
The further secondary endpoints of the study are overall survival, the number of curative metastasis resections, as well as safety and patient-reported outcomes, including quality of life.
Pharmacokinetic profile and gene expression level of folate relevant genes in tumour cells are the exploratory endpoints.
Currently, the study is progressing at 90 sites in the US, Canada, Europe, Australia and Japan.
In December last year, Isofol met its primary recruitment objective by enrolling 440 subjects in this trial. Meanwhile, the enrolment continued in Japan to recruit a total of 56 subjects in the country.
Solasia Pharma will provide funding and manage clinical development works in Japan. It will also oversee registrational filing and after regulatory approvals, the company will commercialise arfolitixorin in the country.
Isofol Medical CEO Ulf Jungnelius said: “I am satisfied that we now have completed the recruitment of the Japanese patients, an important step on the way to receive market approval in Japan, the second-largest oncology market worldwide.
“We are now looking forward to continue working with Solasia on the development and registration of arfolitixorin to bring a new treatment option to patients living with mCRC in Japan.”
The results from the AGENT study will be reported during the first half of next year, Isofol noted.