Isofol Medical AB was founded in 2008 based on the research by Professor Bengt Gustavsson and his collaboration with the German group of Merck & Cie, the world’s leading manufacturer of folate-based therapies. In 1978 Bengt Gustavsson co-discovered that the folate-based therapy leucovorin (LV) could significantly increase the efficacy of the cytotoxic antimetabolite fluorouracil (5-FU). This discovery subsequently led to the widely used 5-FU/LV combination regime that is now a gold standard in the treatment of colorectal cancer.
Professor Gustavsson hypothesised that the reason only a minority of patients responded to treatment with leucovorin was due to their ability to metabolically activate leucovorin. A collaboration with researchers at Merck & Cie to synthesise the active metabolite of leucovorin resulted in a stable racemic form of the metabolite. After a rigorous research and development process, in 2005, Merck & Cie finally managed to do what had previously been considered impossible; to synthesize a stable, non-racemic form of metabolite. This novel pharmaceutical substance was named arfolitixorin (Modufolin®).
To verify the original hypothesis, a clinical development program was designed where the active ingredient of arfolitixorin (Modufolin®) could be tested. In order to fund the clinical program and to enable commercialisation of arfolitixorin (Modufolin®), professor Gustavsson co-founded Isofol Medical AB together with Yield Life Science (publ) AB. Over the years, more than a hundred new shareholders have joined the two founders in the goal to increase the efficacy and reduce the side effects of antimetabolites to improve the outlook for the majority of cancer patients undergoing chemotherapy treatments.
Isofol now has ongoing combined phase I and II clinical trials to verify the benefits of arfolitixorin (Modufolin®) as a co-therapy in the treatment of cancer. To date, arfolitixorin (Modufolin®) has been shown to be safe after treating numerous patients and Isofol is to commence the ISO-CC-007 study to prove the efficacy of arfolitixorin (Modufolin®) in colorectal cancer patients.