12 Jan First Patient Dosed in Phase 3 AGENT Study for Metastatic Colorectal Cancer

MedicalResearch.com interview with:

Anders Rabbe

Anders Rabbe
CEO of Isofol Medical

MedicalResearch.com: What is the background for this study? How common is colorectal cancer? 

Response: Colorectal cancer (CRC) is one of the most common forms of cancer with more than 1.8 million new cases identified globally every year. Due to a lack of new therapeutic options and a high mortality rate, colorectal cancer is a disease with a significant unmet need for effective new treatments.

Isofol is developing arfolitixorin (Modufolin®) to improve the efficacy of standard of care chemotherapy for advanced colorectal cancer. Arfolitixorin is the company’s proprietary drug candidate currently being studied in a global Phase 3 AGENT study (ISO-CC-007) as a first-line treatment for patients with metastatic colorectal cancer (mCRC), which just enrolled its first patient in December of 2018.

 MedicalResearch.com: How does arfolitixorin differ from other treatments for CRC? 

Response: Isofol is developing a treatment using a very different approach.

While just about everyone in the cancer space is pouring resources into  combination immunotherapy approaches, so far there is little evidence that this approach works in advanced colorectal cancer. Isofol is developing arfolitixorin, a drug intended to improve the efficacy of chemotherapy regimens for advanced colorectal cancer.

There have been no significant advances in the treatment of CRC for decades. The current chemotherapy-based standard of care, 5-fluorouracil (5-FU) in combination with folates, has been used for decades but only benefits 20-25% of CRC patients. Folate-based therapies are used in the standard of care treatment regimen for colorectal cancer to improve the efficacy of 5-FU by providing MTHF ([6R]-5, 10-methylentetrahydrofolate). However, currently available folate-based therapies require several metabolic steps before becoming therapeutically active. A majority of CRC patients have limited ability to complete these metabolic steps, resulting in poorer tumor treatment outcomes. Arfolitixorin directly provides MTHF, and therefore does not require any metabolic activation. We therefore believe that arfolitixorin could potentially benefit all patients with advanced CRC treated with 5-FU-based chemotherapy.

MedicalResearch.com: What are the main findings of earlier studies?

Response: MTHF plays a vital role in the efficacy of chemotherapy. Data from a Phase 1/2 study (ISO-CC-002) with arfolitixorin show significantly increased levels of MTHF in tumors following equivalent doses of arfolitixorin versus other folate-based therapies such as leucovorin or levoleucovorin.

Data from a Phase 2a dose escalation study (ISO-CC-005) with arfolitixorin show that 50% of patients (6/12) had partial response to arfolitixorin in combination with FOLFOX chemotherapy treatment and 100% (5/5) patients at the highest dose had a partial response (based on overall response rate).

MedicalResearch.com: What should readers take away from your report?

Response: The enrollment of the first patient in our global AGENT study takes us one step closer to bringing a new treatment option to patients suffering from mCRC, a devasting disease with poor outcomes. Arfolitixorin is being developed to improve the efficacy of standard of care chemotherapy and if approved would be the first new therapeutic agent in decades for first-line treatment for patients with mCRC. To date, arfolitixorin has demonstrated promising efficacy and safety in the treatment of mCRC.

It is our intention that arfolitixorin will be implemented in all 5-FU-based chemotherapy treatments in advanced colorectal cancer. As we look to the future, we envision arfolitixorin being further developed for other indications, including gastric, head and neck, breast and pancreatic cancers, where 5-FU-based regimens are used.

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Last Updated on January 12, 2019 by Marie Benz MD FAAD