Isofol Receives Clinical Use Patent Approval in the United States for Drug Candidate arfolitixorin

GOTHENBURG, Sweden, June 25, 2019 – Isofol Medical AB (publ), (Nasdaq First North Premier: ISOFOL), today announced approval of a Clinical Use Patent for arfolitixorin in the United States. The patent expires in 2038 and is the second patent in a series of clinical patent applications for arfolitixorin to be granted. The patent covers a dose regimen for treating solid tumors, such as colorectal, stomach, breast and liver cancer.

The now granted patent, US 10,328,079, includes a dose regimen involving two or more injections of arfolitixorin in combination with 5-fluorouracil (5-FU). These two agents may also be given in combination with other anticancer drugs, such as oxaliplatin, irinotecan and bevacizumab.

Anders Rabbe, chief executive officer of Isofol, commented: “This patent, which has been applied worldwide, is a clinical patent based on data derived from a study of arfolitixorin and 5-FU in metastatic colorectal cancer patients. The data demonstrated superior activity of arfolitixorin and 5-FU compared to the standard of care therapy, leucovorin and 5 -FU. The patented dose regimen is closely related to the one used in our ongoing global pivotal Phase 3 study, AGENT, a multicenter study in patients with metastatic colorectal cancer”.

For further information, please contact

Isofol Medical AB (publ)
Anders Rabbe, CEO
Phone: +46 (0)707 646 500

Investor Relations
LifeSci Advisors
Hans Herklots
Phone: +41 79 598 7149

LifeSci Public Relations
Alison Chen
Phone: +1 646 876 4932

Certified Adviser
FNCA Sweden AB
Phone: +46 (0)8 528 003 99

This information is information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 16:30 CET on June 25, 2019.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase 3 clinical trial, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

About Isofol Medical AB (publ)

Isofol Medical AB (publ) is a clinical stage biotech company developing arfolitixorin to improve the efficacy of standard of care chemotherapy for advanced colorectal cancer by increasing tumor response and progression free survival. Isofol holds a worldwide exclusive license agreement with Merck KGaA, Darmstadt, Germany to develop and commercialize arfolitixorin for oncology indications. Isofol Medical AB is traded on the Nasdaq First North Premier. Certified Adviser is FNCA Sweden AB.