Common treatment

Folates are the most

commonly used drugs in cancer

treatment today

Situation of today

A majority of patients do not
fully benefit from their
folate treatment today

About Modufolin

Modufolin® holds the
potential to replace all
folates in cancer treatments

Devlopment Status

US and EU regulatory
authorities have endorsed the
Modufolin® development plan

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Modufolin® in brief

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Folates are the most commonly used drugs in cancer treatment today

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As part of their cancer treatments, more than 500 000 patients are treated with folate-based therapies annually in the US, Europe and Japan – more than any other single cancer drug.

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A majority of patients do not fully benefit from their folate treatments today

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All current folate-based therapies used in cancer treatment, including leucovorin and levoleucovorin, are prodrugs that need multiple activation steps into the active metabolite of Modufolin® (MTHF) to exert their actions. Isofol has shown that a few genes determine cancer patients’ ability to activate these prodrugs and that the expression levels of these genes also are correlated with treatment outcome. This ability is genetically regulated and requires a number of conversion enzymes and folate transporters.

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Modufolin® holds the potential to replace all folates in cancer treatments

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Modufolin® is the key active metabolite of all folate-based cancer drugs used today and does not require metabolic activation to exert its action (Download a publication about the ‘Chemical rational and mechanism of action). Against this background, Modufolin® may be beneficial regardless of the patient’s genetic ability to activate folates and thus holds the potential to replace the folates used in cancer treatment today.

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US and EU regulatory authorities have endorsed the Modufolin® development plan

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During 2016, Isofol has had successful meet­ings with regulatory authorities both in the US (FDA) and in Europe (EMA). Both agencies have endorsed Isofol’s clinical development plan for Modufolin® in colorectal cancer and are in agreement with Isofol about the requirements for registration of Modufolin®. Isofol’s development plan aims at for the completion of a proof-of-superiority program, in 2018, and the first market registration, in 2021.

About Modufolin

Modufolin® – A better
and more efficient treatment

Modufolin® has the potential to benefit the majority of cancer patients
being treated with chemotherapy.

Read more about Modufolin and how it works