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 Modufolin®.
To verify the original hypothesis, a clinical development program was designed where the active ingredient of Modufolin® could be tested. In order to fund the clinical program and to enable commercialisation of 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 Modufolin® as a co-therapy in the treatment of cancer. To date, Modufolin® has been shown to be safe after treating numerous patients and Isofol is to commence the ISO-CC-006 study to prove the efficacy of Modufolin® in colorectal cancer patients.
5FU-LV treatment regimen co-discovered by Prof. Bengt Gustavsson.
Racemic MTHF synthesized by Merck & Cie.
Modufolin® manufactured as a stable pharmaceutical composition by Merck & Cie.
Isofol Medical founded.
Swedish MPA approves Isofol's first clinical trial. Isofol's first patent family granted in Europe.
Isofol Medical initiates phase I and II clinical trials with Modufolin®, its lead clinical candidate.
Isofol Medical received approval to start a randomized phase I/II pharmacokinetic and pharmacodynamic study of Modufolin® in patients with colon cancer.
Isofol Medical AB entered into a worldwide exclusive supply & license agreement with Merck KGaA and Merck & Cie (Merck) for the use of Modufolin® in cancer treatment.
Recipharm to exclusively manufacture Modufolin® for Isofol Medical.
Patent covering use and pharmaceutical composition of Modufolin® allowed by US patent and trademark office.
FDA and EMA endorse Isofol Medical’s clinical development plan for Modufolin in CRC.