Patients who have completed the six months trial were provided the opportunity to continue treatment with ISA247 as part of an extension to the initial trial. This six-month extension period will provide longer-term safety and efficacy data for the drug in de novo kidney transplant patients.
Previously, Isotechnika has received permission from Health Canada and the FDA to allow patients to remain on ISA247 until the drug is commercially available.
Robert Foster, Isotechnika’s chairman and CEO, said: “The six-month data is expected to be available in the second quarter of this year. We believe that the final data will confirm ISA247 as an efficacious treatment for kidney transplant patients with an enhanced safety profile over current calcineurin inhibition therapies. Efficacy and enhanced safety profile will be key characteristics of the next generation of calcineurin inhibitors and ensure that calcineurin inhibition remains the foundation of evidence-based medicine.”