The initiation of Isofol Medical pivotal phase III study ISO-CC-007 (the Agent study – A randomized, multicentre, parallel-group, Phase III study to compare the efficacy of arfolitixorin versus leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab in patients with advanced colorectal cancer) approaches. In this study, we aim to compare our drug arfolitixorin with the standard treatment for metastatic colorectal cancer. The study is planned to include 440 patients in 8 different countries in the EU and North America. Half of the patients will be treated with arfolitixorin in combination with the conventional treatment and the other half will receive the corresponding treatment but with Leucovorin instead of arfolitixorin. Thereafter will among other things the tumor growth be closely observed in order to compare the efficacy between the both treatments.
As part of the preparations for study start, Isofol holds two meetings in order to train the study monitors. A monitor is a professional who supervise a clinical study and ensures that it is conducted, documented and reported according to the study protocol and in accordance with applicable laws and regulations. The first meeting was held in Frankfurt on 25 September, where Isofol’s employees presented the clinical activities and trained nine European monitors in detail regarding the ISO-CC-007 protocol, which is necessary to ensure that the study is conducted according to international ethical and scientific quality standards. The second monitor meeting will be held on November 6th together with the Precision Medicine Group in Montreal, to inform and educate the American monitors that will perform quality control on the data from the ISO-CC-007 phase III study in North America.
After completion of the two monitor meetings, Isofol is well prepared for study initiation and in cooperation with the monitors Isofol has the resources required to ensure that the ISO-CC-007 study is performed according to plan and with consistently high quality.