Do you or someone close to you have metastatic colorectal cancer

Read more about the AGENT Study

Do you or someone close to you have metastatic colorectal cancer

Read more about the AGENT Study

Information in relation to COVID-19

The AGENT Study is conducted at nearly 80 research centers throughout the U.S., Canada and western Europe. This global study is a Phase 3 clinical trial evaluating arfolitixorin as a first-line treatment of metastatic colorectal cancer (mCRC).

Colorectal cancer (CRC) is one of the most common forms of cancer with more than 1.8 million new cases identified globally every year. There have been no significant advances in the treatment of CRC for decades. Arfolitixorin is a new experimental therapy being developed to improve the effectiveness of standard of care chemotherapy for patients living with mCRC.

Learn more about the AGENT Study
arfolitixorin animation
The animation that explains how arfolitixorin works in cancer cells, describing the mechanism of action.

Listen to recent episode from The Cancer Gene podcast features Anders Rabbe, CEO of Isofol, discussing colorectal cancer and the company’s ongoing Phase 3 study

Information in relation to COVID-19

The spread of the COVID-19 pandemic is a major public health issue affecting societies and companies all over the world and will have a significant impact on the global healthcare systems. Isofol’s top priority is to ensure the safety of patients, healthcare professionals, employees and suppliers involved in the ongoing AGENT study.

Leading national and global health organizations, regulatory agencies, healthcare systems and countries are actively updating their guidelines, including guidance around ongoing clinical trials, and Isofol is taking necessary steps to fully comply with new guidance. The company has taken proactive measures to ensure continuity of the global Phase 3 AGENT study, which will continue to enroll patients in line with regulatory guidelines and site capabilities.

We encourage everyone to stay safe by following measures outlined by your local authorities and health officials. Please stay tuned for further updates. If you have any questions regarding the impact of the pandemic on the AGENT study, please contact us for more information.

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For a glossary of more terms related to clinical studies, please see: https://clinicaltrials.gov/ct2/about-studies/glossary

Glossary

Control - an experiment or observation intended to help minimize the effects of all variables in a study that are not the target of the study itself

Clinical study - an organized research program used to evaluate the safety and effectiveness of a new medical treatment or device

Clinical study coordinator - a person with administrative responsibilities at an individual clinical study site that helps with enrollment and maintaining contact with patients and study organizers

Contract research organization - a third party company often hired to handle the logistics of running a large-scale clinical study that involves multiple clinical study sites

Duration of response (DOR) - time between the initial response to therapy and subsequent disease progression or relapse

Eligibility criteria - pre-defined standards used to determine if a person is able to take part in a clinical study

Endpoints - biomedical or behavioral measures of whether or not a treatment or device is effective determined during study design

First-line treatment - the first treatment a patient receives for a certain stage of disease

Food and Drug Administration (FDA) - a federal agency of the U.S. charged with ensuring the safety of food and drugs. The main federal oversight organization for all clinical studies

Health-related biomedical or behavioral outcomes - conditions that can be used to reflect or measure the overall health of an individual (for example: heart rate, lung capacity, disease progression measures such as tumor size, etc.)

Intervention - a treatment or process that is a focus of a clinical study. For example, giving a study subject a new experimental drug is an intervention, as is giving someone a placebo

MTHF - Methylenetetrahydrofolate

Overall response rate (ORR) - portion of patients with a tumor size reduction of a predefined amount

Phase - the name for a stage of clinical testing

Placebo - an inactive substance or other innocuous intervention that looks the same as and is given the same way as the experimental drug or intervention that is the focus of a study

Principal investigator - the person who is responsible for the scientific and technical direction of the entire clinical study, either at a single clinical study site or over the whole study

Progression free survival (PFS) - time during and after treatment of a disease that a patient lives with the disease without it getting worse

Toxicology - a branch of science concerned with measuring the nature and effects of poisons or other harmful agents