Isofol Medical AB (publ) today announce that the company will in the future be adopting the generic name arfolitixorin for its lead candidate, up to now referred to as Modufolin®. Arfolitixorin was recently accepted by World Health Organization (WHO) as the International Non-proprietary Name (INN) for the active ingredient of Isofol’s lead product Modufolin®.
“We are delighted that the WHO has recognized the unique nature of our compound by accepting arfolitixorin as an INN. This is an important step towards bringing a new drug to market,” said Anders Rabbe, Chief Executive Officer at Isofol Medical AB. Chief Medical Officer, Karin Ganlöv, commented that “this comes at an important time as Isofol is preparing to start the pivotal phase III study ISO-CC-007 in treatment of advanced colorectal cancer. Arfolitixorin will now be used in all scientific communication with the medical community.”
- The generic name arfolitixorin for Modufolin® was taken under consideration by the World Health Organization as a Proposed International Non-proprietary Name (INN) in July 2 of 2017.
- As per no objection during the following 4 months, arfolitixorin has reached the status of recommended INN and will be included in the forthcoming list of recommended INNs, generic names, published by the WHO.
- Isofol Medical is also in the process of selecting a novel brand name for arfolitixorin. This is planned to become approved by Medical authorities well in time before market approval.
International Non-proprietary Names
International Non-proprietary Names (INN) facilitate the proper identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized. The INN system has been coordinated by the World Health Organization since 1953 and has a constitutional mandate to “develop, establish and promote international standards with respect to biological, pharmaceutical and similar products”.
For more information, please contact:
Anders Rabbe, CEO, Isofol Medical AB (publ)
Phone: +46 (0)707 646 500
About arfolitixorin (Modufolin®)
Arfolitixorin (Modufolin®) is developed to increase the efficacy of the cytotoxic agent 5-fluorouracil (5FU) and as a rescue drug after high-dose methotrexate treatment. Arfolitixorin (Modufolin®) is suitable for all patients irrespective of their capacity to activate folates since it doesn’t require metabolic activation to exert its effect. The active ingredient in arfolitixorin (Modufolin®), [6R]-5,10-methylenetetrahydrofolate, is the key active metabolite of the widely used folate-based drugs leucovorin and levoleucovorin.
About Isofol Medical AB (publ)
Isofol Medical AB (publ) is a drug development company within the field of oncology developing arfolitixorin (Modufolin®), primarily as a treatment for advanced colorectal cancer and as a rescue drug after high-dose methotrexate treatment in osteosarcoma (bone cancer). Through a worldwide exclusive license agreement, Isofol holds the rights to develop and commercialise arfolitixorin (Modufolin®) within oncology with access to the unique patented production process and the production capabilities of Merck KGaA, Darmstadt, Germany. Isofol Medical AB is traded on the Nasdaq First North Premier. Certified Adviser is FNCA Sweden AB.