Isofol Medical

The information in the press release is intended for investors.

The clinical study aims to evaluate the drug candidate arfolitixorin as part of the standard 5-FU-based first-line therapy of metastatic colorectal cancer. The study is being conducted at Charité - Universitätsmedizin Berlin – one of the world’s top-ranked hospitals – where the first patient now has been included and dosed with arfolitixorin.

The study will be conducted in two stages, where the initial phase Ib part will assess the benefit/risk profile of escalating doses in a new dosing regimen that is expected to increase the efficacy further as compared to previously conducted trials. The second part of the trial compares, in line with FDA and EMA guidance, the highest dose from phase Ib with one of the lower doses, with efficacy parameters as primary endpoints.

“It is very gratifying that we are on track with the study and have been able to include the first patient. This is another important milestone achieved in a short time in our plan to take arfolitixorin closer to market. We are confident that our drug candidate can make a great difference for patients with advanced cancers and are looking forward to continuing the study at a high pace in close collaboration with Charité - Universitätsmedizin Berlin,” says Petter Segelman Lindqvist, CEO of Isofol.

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 08:15 CEST on April 28, 2025.

About Isofol Medical AB (publ)
Isofol Medical AB (publ) is a research-based biotechnology company working to improve the prognosis for patients with severe forms of cancer. The company's drug candidate arfolitixorin aims to increase the effect of first-line standard treatment for several forms of solid tumors and is currently being studied in colorectal cancer, the world's third most common cancer, where the medical need for better treatments is urgent. A phase Ib/II study is now being conducted with a new dosing regimen that is expected to optimize the effect of the drug candidate. Isofol Medical AB (publ) is traded on Nasdaq Stockholm.
www.isofolmedical.com