On January 30, 2020 Isofol Medical AB (publ) (Nasdaq First North Premier: ISOFOL), reported that the recruitment and treatment of patients in the company’s Phase 1/2a study with arfolitixorin has been completed (Press release, Isofol Medical, JAN 30, 2020, View Source [SID1234553729]). Totally 101 patients have been treated at 10 hospitals in the Nordic countries and Europe. The final analysis has started and study data is expected to be presented at ESMO (Free ESMO Whitepaper) 2020.
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Ulf Jungnelius, M.D., Chief Executive Officer of Isofol, comments: "ISO-CC-005 has fulfilled its purpose by determining the dose we have chosen for further development in our Global Phase 3 AGENT study. Our focus now is taking the AGENT study in goal and submitting the results for a market approval. "
Isofol’s target with the ISO-CC-005 study was to develop an effective and safe dose of arfolitixorin for continued clinical development. An expanded patient group to determine the safety profile of arfolitixorin in combination with the today’s standard of care in first-line metastatic colorectal cancer, has now been conducted in accordance with protocol and the study has fulfilled its purpose and concluded.
The information was submitted for publication, through the agency of the contact person set out above, at 08:15 CET on January 30, 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.