Isofol’s drug candidate arfolitixorin receives additional clinical patent approval in the United States

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GOTHENBURG, Sweden, May 5, 2020 – Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), today announced approval of a clinical patent for arfolitixorin in the United States. The patent expires in 2038 and is a divisional patent for the master patent granted in the US in May 2019. The now granted patent (US 10,639,311) is more specifically focused on the dose regimen used in the ongoing clinical AGENT study.

This regime has shown superior effectiveness of reducing tumor growth compared to leucovorin and 5-fluorouracil. This better effect is due to a stronger inhibition of Thymidylate Synthase (TS), a vital enzyme for the DNA synthesis and tumor growth, which can be simply measured as the increased level of the biomarker deoxyuridine in blood samples from patients. The master patent refers to the way to increase the blood concentration of deoxyuridine, a blood biomarker that indicates inhibition of tumor growth in the treatment of cancer patients.

Ulf Jungnelius, CEO of Isofol, commented: “This patent is considered of particular importance for Isofol. It is a clinical patent that mirror the ongoing global Phase 3 study AGENT with arfolitixorin demonstrating potential superior activity for arfolitixorin and 5-fluorouracil treatment compared to today’s standard of care therapy with leucovorin and 5-fluorouracil.”

For further information, please contact

Isofol Medical AB (publ)
Jarl Ulf Jungnelius, M.D., Chief Executive Officer
E-mail: jungnelius@isofolmedical.com
Phone: +46 (0) 709 16 89 55

Certified Adviser
FNCA Sweden AB
E-mail: info@fnca.se
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 07:45 CET on May 5, 2020.

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 study, 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 (publ) is traded on the Nasdaq First North Premier Growht Market. Certified Adviser is FNCA Sweden AB.

www.isofolmedical.com

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