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.
GSK releases decade-long data on Shingrix efficacy
GSK announces positive EAGLE-1 results for gepotidacin in gonorrhoea treatment
Boehringer Ingelheim reports strong growth in 2023 and accelerates late-stage pipeline
Charles River Laboratories launches AMAP to reduce animal testing reliance
PureTech completes enrollment in Phase 2b ELEVATE IPF trial for LYT-100
Cybin secures additional US patent for CYB003 breakthrough therapy programme
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Biophytis reinforces obesity IP with new patent application
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Fusion Antibodies plc secures contract for OptiPhage library development
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients