Promoting the development
Isofol Medical AB was founded in 2008 and was based on a research partnership between Professor Bengt Gustavsson and Merck & Cie, the world’s leading manufacturers of folate-based therapies. In 1978, the research team discovered that the folate-based treatment, leucovorin (LV), significantly increased the effect of the cytotoxic antimetabolite, fluorouracil (5-FU). This discovery subsequently led to the 5-FU/LV combination that now lies at the core of colorectal cancer treatment.
Professor Gustavsson formulated the hypothesis that the reason why only a few of his patients responded fully to the leucovorin treatment was their reduced genetic ability to effectively use key enzymes involved in folate metabolism. Although many judged it as impossible, Merck & Cie finally succeeded after long-lasting extensive research to produce the nature-identical folate [6R]-5,10-methylenetetrahydrofolic acid ([6R]-MTHF) in a pure and stable form as a hemisulfate salt. In contrast to LV, [6R]-MTHF needs no metabolic activation and can be directly used as a potent modulator of 5-FU activity. Today the substance [6R]-MTHF is named arfolitixorin.
A developmental programme in which the active component of arfolitixorin could be tested clinically was designed in order to confirm the original hypothesis. The programme was expensive and Isofol Medical AB was founded in order to finance the development work and enable any potential commercialisation. The original founders were Professor Gustavsson and Yield Life Science (publ.) AB, but the company has since grown, and by 2016, over 100 new shareholders had joined in the hope of realising the vision of improving the efficacy and minimising the side effects of treating cancer with antimetabolites.
The Phase III AGENT Study
Isofol has now initiated the pivotal phase III AGENT study in order to demonstrate the efficacy of arfolitixorin in the treatment of patients with colorectal cancer.