Invitation to a conference call and webcast in connection with Isofol receiving recommendation to complete the global Phase III AGENT study for market registration as planned with 440 patients
GOTHENBURG, Sweden, March 22, 2021 - Isofol Medical AB (publ) (“Isofol”), (Nasdaq First North Premier Growth Market: ISOFOL) announced on 19 March 2021 that the independent Data Safety and Monitoring Board (iDSMB) has recommended continuation of the global Phase III AGENT study with 440 patients, in accordance with the study design for the drug candidate, arfolitixorin. In connection with this, Isofol invites investors, analysts and media to a conference call and webcast on March 22, 2021 at 14:00 (CET).
The presentation will be held by Isofol's CEO Ulf Jungnelius in English and will conclude with a Q&A session. Questions can be asked on the telephone conference or in written form through the webcast. No preregistration is needed.
Date and time
March 22, 2021 at 14:00 (CET)
Call in details will be made available at the following link in good time before the start of the presentation:
After the presentation, a recording of the webcast will be available on the webcast link.
For further information, please contact
Isofol Medical AB (publ)
Jarl Ulf Jungnelius, M.D., Chief Executive Officer
Phone: +46 (0) 709 16 89 55
FNCA Sweden AB
Phone: +46 (0)8 528 003 99
The information was submitted for publication, through the agency of the contact person set out above, at 08:50 CET on March 22, 2021.
About the AGENT study
The Phase III 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 90 sites in the U.S., Canada, Europe, Australia and Japan. Further information about the study, including patient eligibility requirements, is available at www.clinicaltrials.gov id: NCT03750786.
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 III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more 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 Growth Market. Certified Adviser is FNCA Sweden AB.