Receive our newsletter – data, insights and analysis delivered to you
  1. News
May 7, 2021

Isofol concludes Japanese enrolment in Phase III cancer drug study

Isofol Medical has concluded the enrolment of Japanese subjects in the global Phase III AGENT study of drug candidate arfolitixorin in patients with first-line metastatic colorectal cancer (mCRC). 

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.

Content from our partners
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide
Why Asia-Pacific is the next frontier for decentralized clinical trials

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy