Isofol Expands Arfolitixorin Phase Ib/II Colorectal Cancer Trial Sites to Accelerate Patient Recruitment
核心洞察
Isofol Medical AB is adding new clinical trial sites, including Essen University Hospital in Germany, to its ongoing phase Ib/II study of arfolitixorin in colorectal cancer (搜索).
The expansion follows regulatory approval of an amended study design by German authority BfArM and aims to keep the company on track to enter phase II before year-end.
The phase II segment is planned across 10–15 sites in Germany and additional European countries, complemented by a bridging study in Japan through Solasia Pharma K.K.
Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL) announced on August 24, 2026, that it is expanding the number of clinical trial sites in its ongoing phase Ib/II study of the drug candidate arfolitixorin in colorectal cancer (搜索). The expansion is intended to accelerate patient recruitment and keep the company positioned to transition into phase II before year-end.
Arfolitixorin and the Study Design
Arfolitixorin is a proprietary clinical-stage drug candidate designed to enhance the efficacy of established cancer treatments. Based on extensive clinical research, the compound is now being tested in a phase Ib/II clinical study with an optimized dose regimen, initially conducted at the German hospital Charité – Universitätsmedizin Berlin. According to Isofol, the drug candidate has the potential to fill a known treatment gap in conventional cancer care.
Following approval of an amended study design by the German regulatory authority BfArM, Isofol was able to expand the study to additional sites to broaden patient recruitment in both the final part of phase Ib and in phase II. The company is now adding Essen University Hospital in Germany and is also preparing to shortly include another German university hospital. Both sites will begin enrolling patients for the ongoing study already during phase Ib.
Accelerating Recruitment Toward Phase II
"We are delighted to collaborate with Prof. Dr. med. Stefan Kasper-Virchow. First of all, we are pleased to associate this distinguished professor and Universitätsklinikum Essen with us, and we also believe that the new clinical trial site will provide a significant boost to patient recruitment. This ensures that we remain positioned to enter phase II before year-end," said Petter Segelman Lindqvist, CEO of Isofol.
The phase II part of the study will be conducted at 10–15 study sites in Germany and several additional European countries. Through a collaboration with the Japanese pharmaceutical company Solasia Pharma K.K., patients in Japan will also be recruited, in parallel through a so-called bridging study.
Unmet Medical Need in Colorectal Cancer
Colorectal cancer (搜索) is the third most common form of cancer globally and the second most common cause of cancer-related death, according to the World Health Organization (WHO). The need for new treatments in the field is therefore very high, and Isofol describes arfolitixorin as a next-generation folate treatment designed to enhance the efficacy of established standard treatments for several types of solid tumors.