ISOFOL 12,84 SEK (-0,16) 03 Dec 2021 17:29 GLOSSARY GLOSSARY The following explanations are helpful in understanding certain specific terms and expressions that Isofol uses: EMA European Medicines Agency FDA Food and Drug Administration HDMTX High-dose treatment with methotrexate IND Investigational New Drug Application (for the FDA) mCRC metastaserad kolo­rektal­cancer MTHF Metylentetrahydrofolat MTX Metotrexat NDA New Drug Application ORR Objective Response Rate PFS Progression Free Survival Preclinical study Research that takes place before a drug or treatment method is sufficiently documented to be studied in humans. Includes testing of substances on tissue samples and subsequent testing on laboratory animals. Clinical study/trial Investigation of a new drug or treatment method on healthy volunteers or patients where the aim is to study the efficacy and safety of an, as yet, unapproved form of treatment. Clinical phase l The first time when a new substance is given to humans. Phase I studies are often carried out on a small number of healthy volunteers to study safety and dosage for an, as yet, unapproved form of treatment. Clinical phase ll Phase ll refers to the first time when a drug under development is given to patients to study the safety, dosage and efficacy of an, as yet, unapproved form of treatment. Clinical phase lll Phase III studies/trials comprise numerous patients and are often conducted over an extended period of time. They are intended to map the efficacy and side effects of the drug under ordinary but still closely monitored conditions. Pivotal study (study forming the basis for a decision) A clinical study designed to provide data on the efficacy and safety of the drug when applying for marketing authorisation from the FDA or EMA, for example. About Isofol Isofol Medical AB (publ) is a biotech company within the field of oncology developing arfolitixorin, primarily as a treatment for advanced colorectal cancer and as a rescue drug after high-dose methotrexate treatment in osteosarcoma (bone cancer). Contact Isofol Medical AB (publ) Biotech Center, Arvid Wallgrens Backe 20 SE-413 46 Gothenburg Sweden Phone: +46 (0)31 7972280 E-mail: info@isofolmedical.com Newsletter and Privacy Policy Sign up here to receive information, press releases and news and agree to Isofol’s processing of your personal data according to the company’s Integrity. Isofol´s Integrity Policy (general) Isofol´s Integrity Policy (clinical studies) ©2019 Isofol Medical AB (publ) Biotech Center, Arvid Wallgrens Backe 20, SE-413 46 Gothenburg, Sweden. Isofol´s Glossary Isofol's website uses cookies to improve and customize your visit. By continuing you accept this.Accept Read More