Tor 25 jul / År 42 / Nr 3 2024

Outcome of advanced oncological treatments to change significantly

Isofol Medical AB is a small Swedish biotech company with the potential to significantly change the outcome of advanced oncological treatments. The main target is colorectal cancer, which is one of the most aggressive and deadly forms of cancer in the world today.

Around 1.8 million people are diagnosed with colorectal cancer each year and statistics show that in 20 years time, the numbers will at least have doubled. Of the current 1.8 million cases of today, around 320.000 are in the advanced metastatic form for whom the survival rate is low. Only around 10 per cent of these patients are likely to live for over five years, and most of them with a great impact on their lives.
The standard treatment for colorectal cancer, using the pharmaceutical substance leucovorin, has been around for over 40 years. It is tried and tested but nonetheless it does not work successfully for most patients. The need for a safe and efficient treatment of advanced colorectal cancer is evident.
As opposed to many other forms of cancer, such as breast cancer, the innovation rate within colorectal cancer treatments has so far been low. Isofol develops the pharmaceutical drug candidate arfolitixorin, primarily used as a treatment for colorectal cancer and as a rescue drug after high-dose methotrexate treatment of bone cancer. Other potential uses for arfolitixorin also includes the treatment of pancreatic cancer, breast cancer, stomach cancer, and head and neck cancers.

May turn a deadly disease into a chronic one
Now, at the initial stage, Isofol is focusing on developing treatments for colorectal cancer in advanced stages of metastatic development.
Isofol is now focused on the ongoing global Phase 3 study, currently recruiting patients in the USA, Canada, Europe, Australia and Japan. Approximately 90 hospitals are participating in recruiting around 440 patients who will receive first line treatment for metastatic colorectal cancer. By the end of July 2020, 330 patients had started treatment in the study.
The study involves two treatments and will aim to compare the outcome of each one. The first patient group will be treated with arfolitixorin and the second with leucovorin, both in combination with the 5-FU and oxaliplatin chemotherapeutic agents and the biological therapy, bevacizumab.
The primary focus of the study will be to measure the percentage of patients who experience tumour size reduction, (Objective Response Rate, ORR). The secondary endpoint will be the measurement of Progression Free Survival (PFS), that is the time until the tumour begins to grow again or the patient dies.
“A statistically significant tumour shrinkage in 55-60 per cent of patients should be demonstrated. Our objective is to achieve a 10-15 per cent improvement in ORR in those patients treated with arfolitixorin in comparison with those treated with leucovorin”, explains Ulf Jungelius, Managing Director at Isofol Medical AB.
“What we are hoping to prove, after several years of research and development, is that we can turn a deadly disease into a chronic disease. We can certainly not cure the disease completely, but we can help relieve symptoms and we can prolong the lives of significantly more patients than what has been possible to do in the past”, says Ulf Jungelius.