A milestone is reached with the inclusion of 330 patients in the AGENT-study – opening up for the interim analysis

On July 21, 2020 Isofol Medical AB (Nasdaq First North Premier Growth Market: ISOFOL), reported that 330 patients now have been included in the global phase III-study AGENT (Press release, Isofol Medical, JUL 21, 2020, View Source [SID1234562170]). The interim analysis – which aims to evaluate efficacy data – will be initiated when these 330 patients have been evaluated after 16 weeks treatment and two tumor screenings. The result from the analysis is expected around year end.

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Isofol’s drug candidate, arfolitixorin, is evaluated for treatment among patients with first-line metastatic colorectal cancer (mCRC). The study is currently being conducted in Australia, Europe, Japan, Canada and the US on more than 90 clinics and is expected to include in total 440 patients.

A milestone has been reached as 330 patients now have been included in the AGENT-study and thereby the interim analysis will be initiated after 16 weeks of treatment and two tumor evaluations. The analysis is performed by an independent committee, the Data Safety Monitoring Board (DSMB) and the results are expected to be communicated around the turn of the year. The outcome is estimated to be either that the recruitment to the study ends after 440 patients or is increased to 660 patients to achieve statistical significance for PFS (Progression-Free Survival).

"We are pleased to have recruited 330 patients and now being able to initiate the interim analysis, which is a large milestone for Isofol. The team has done a fantastic job in these challenging times and we are looking forward to the result from the interim analysis which will decide the next step," says Ulf Jungnelius, M.D, CEO of Isofol.