Isofol Medical AB (publ) (Isofol), a clinical stage biotech company, announces that the independent Data Safety and Monitoring Board (iDSMB) has recommended continuation of the worldwide phase III clinical trial AGENT study with 440 patients, in accordance with the study design for the drug candidate, arfolitixorin. Isofol expects the highest line results for the AGENT study to be available during H1 2022.
The iDSMB recommendation follows a pre-scheduled interim analysis as a part of the study design and was initiated when the 330th patient had been treated for 16 weeks and had two tumor evaluations. iDSMB evaluated safety and efficacy (ORR and PFS). the corporate remains blinded to the interim analysis results.
“The recommendation from iDSMB is encouraging in many ways; first, it doesn’t require us to recruit additional patients which enables us to stay our current timeline with the goal to submit a replacement Drug Application to FDA & EMA in H2 2022. Second, it’s a further confirmation that arfolitixorin shows no signs of increased toxicity which together with previous efficacy data strengthens our belief in arfolitixorin´s potential. Thirdly, we could also be on the market within the US already in 2023”, said Ulf Jungnelius, M.D, CEO of Isofol.
Arfolitixorin is evaluated within the AGENT study for the treatment of patients with first-line metastatic colorectal cancer (mCRC). The study is currently being conducted in Australia, Europe, Japan, Canada and therefore the US in additional than 90 clinics and includes a complete of 440 patients.
Arfolitixorin is Isofol’s brand-name drug candidate being developed to extend the efficacy of ordinary of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied during a global phase III clinical trial study, AGENT. because the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, because it doesn’t require complicated metabolic activation to become effective.
Isofol Medical AB (publ) may be a clinical stage biotech company developing arfolitixorin to enhance the efficacy of ordinary of care chemotherapy for advanced colorectal cancer by increasing tumor response and progression free survival.