GOTHENBURG, Sweden, August 24, 2026 - Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), announces that the company includes additional clinical trial sites to the ongoing phase Ib/II study with its drug candidate arfolitixorin in colorectal cancer.
The information in the press release is intended for investors.
Isofol is developing arfolitixorin, a proprietary clinical-stage drug candidate designed to enhance the efficacy of established cancer treatments. Based on extensive clinical research, arfolitixorin 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. 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 both the final part of phase Ib and in phase II. Isofol 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.
"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," says 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 the collaboration with the Japanese pharmaceutical company Solasia Pharma K.K., patients in Japan will also be recruited. This will take place in parallel through a so-called bridging study.
Colorectal cancer 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.
For more information, please contact
Isofol Medical AB (publ)
Petter Segelman Lindqvist, Chief Executive Officer
E-mail: petter.s.lindqvist@isofolmedical.com
Phone: +46 (0) 739 60 12 56
The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CEST on August 24, 2026.
About Isofol
Isofol Medical AB (publ) is a clinical stage biotechnology company focused on improving outcomes for patients with severe forms of cancer. The Company's drug candidate arfolitixorin, a next generation folate treatment, is designed to enhance the efficacy of established standard treatments for several types of solid tumors. Arfolitixorin is currently being evaluated in phase Ib/II in colorectal cancer, the world's third most common cancer, where there is a significant unmet medical need. Isofol is listed on Nasdaq Stockholm.
www.isofolmedical.com
