study

Final data from the AGENT study confirms topline results

GOTHENBURG, Sweden, November 25, 2022 – Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), announced today that analysis of the AGENT study’s final data confirmed topline results presented on August 3, 2022. Moreover, no predictive gene expressions for clinical response could be identified. Isofol is continuing its efforts to terminate the AGENT study in line with applicable ethical and regulatory requirements, complete the final study report for submission to regulatory agencies and prepare a manuscript for a scientific publication. Isofol is in parallel continuing to investigate possible future paths forward for the company.

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Isofol to present gene expression results from the completed Phase I/IIa ISO-CC-005 study today at ASCO-GI 2021 and updates of the timing of the interim analysis in the AGENT study

GOTHENBURG, Sweden, January 15, 2021 – Isofol Medical AB (publ) (“Isofol”), (Nasdaq First North Premier Growth Market: ISOFOL) announces that a poster presentation is presented today at ASCO Gastrointestinal Cancers Symposium (ASCO-GI). The abstract present results from the Phase I/IIa ISO-CC-005 study which shows a correlation between clinical benefit and gene expression of the folate pathway in patients with metastatic colorectal cancer treated with 5-FU-based chemotherapy in combination with arfolitixorin. Furthermore, Isofol gives an update of the timing of the interim analysis in the global Phase III AGENT study.

Isofol to present gene expression results from the completed Phase I/IIa ISO-CC-005 study today at ASCO-GI 2021 and updates of the timing of the interim analysis in the AGENT study Read More »

First patient enrolled in Isofol’s Pivotal Phase 3 AGENT study in 1st line metastatic colorectal cancer

GOTHENBURG, Sweden, December 18, 2018 – Isofol Medical AB (publ), (Nasdaq First North Premier: ISOFOL) today announced that the first patient has been enrolled in the pivotal Phase 3 AGENT clinical study evaluating arfolitixorin for the treatment of metastatic colorectal cancer (mCRC). AGENT is a randomized, controlled, multi-centre study with blinded independent review of the tumour response.     AGENT (ISO-CC-007) will enrol approximately 440 mCRC patients, aged 18 years or over, to receive arfolitixorin or leucovorin, both in combination with 5-FU, oxaliplatin and bevacizumab. The primary endpoint is Overall Response Rate (ORR) and the key secondary endpoints are Progression Free Survival (PFS) and Duration Of Response (DOR). Top-line data from the study is expected 2021.

First patient enrolled in Isofol’s Pivotal Phase 3 AGENT study in 1st line metastatic colorectal cancer Read More »

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