The First Patient Included in Australia in Isofol's Phase 3 AGENT Study

GOTHENBURG, Sweden, Jan. 24, 2020 /PRNewswire/ -- Isofol Medical AB (publ), (Nasdaq First North Premier: ISOFOL) today announced that the first patient in Australia has initiated treatment in the global Phase 3 AGENT study.

Isofol's drug candidate arfolitixorin is being evaluated in the first line of treatment of metastatic colorectal cancer (mCRC). The study is currently being conducted in the USA, Canada, Europe and now also in Australia. Isofol plans to start trials in approximately 10 clinics in Australia, in addition to the 80 clinics that are already active.

"It is very satisfying that we now have initiated the AGENT study also in Australia and that we are keeping a high pace in our patient enrolment. Leading oncologists shows great interest and commitment in the AGENT study, which gives us confidence," says Ulf Jungnelius, CEO of Isofol.

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 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 the AGENT study

The Phase 3 AGENT study is a randomized, controlled, multi-centre study assessing the efficacy and safety of arfolitixorin, [6R]-5,10-methylene-THF acid (MTHF), compared to leucovorin, both used in combination with 5-FU, oxaliplatin, and bevacizumab, in first line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK)

measurements and level of gene expression of folate relevant genes in tumour cells. The study is designed to show superiority for arfolitixorin over leucovorin. The study is ongoing at approximately 80 sites in the U.S., Canada, Europe and now also Australia. It will also be expanded to include Japanese hospitals as well. Further information about the study, including patient eligibility requirements, is available at www.clinicaltrials.gov id:NCT03750786.

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.

www.isofolmedical.com

For further information, please contact:

Isofol Medical AB (publ)
Jarl Ulf Jungnelius
M.D.
Chief Executive Officer
E-mail: [email protected]  

Certified Adviser
FNCA Sweden AB
E-mail: [email protected]
Phone: +46-8-528-003-99

The information was submitted for publication, through the agency of the contact person set out above, at 13.30 CET on January 24, 2020.

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SOURCE Isofol Medical