Uppsala, Sweden – April 2026 – LINK Medical welcomes the recent regulatory approval granted to Isofol Medical AB (publ) for an optimized design of its ongoing Phase Ib/II clinical study evaluating arfolitixorin in metastatic colorectal cancer. The approval from the German regulatory authority BfArM enables a broader and more robust study design, including expanded inclusion criteria, additional treatment regimens, and the addition of new European study sites.
The approved protocol amendment represents an important step forward in Isofol’s clinical development program, enabling direct comparison with current standard folate therapy and supports accelerated patient recruitment across multiple European countries. This also strengthens the chain from regulatory strategy to efficient clinical execution.
As a Nordic full service CRO, LINK Medical is proud to act as a trusted link between sponsors, regulators, and clinical sites—supporting high quality, compliant, and patient centric clinical development across all phases. With deep expertise in clinical operations, regulatory affairs, and European trial execution, LINK Medical continues to mesh scientific ambition with operational excellence to help innovative therapies move forward efficiently.
