NextCell Pharma AB (publ) ("NextCell" or the "Company") announces that topline results from the ProTrans-Young clinical trial have not yet been reported to the company. The extended timeline is due to the final administrative processing and sign-off of study data taking longer than planned and is not related to the outcome of the study. The data are now being handled by statisticians at Uppsala Clinical Research Center (UCR).
ProTrans-Young is an investigator-initiated study sponsored by Uppsala University, with Professor Per-Ola Carlsson as Principal Investigator. The study includes a total of 66 children and young adults with recently diagnosed type 1 diabetes.
Before statistical analysis, study data in the electronic case report form (eCRF) must be reviewed and signed off by the relevant members of the study teams. For administrative reasons, this process has taken considerably longer than originally anticipated. The final sign-off has now been completed and the data are being handled by statisticians at UCR.
The result from the statistical analysis has not yet been reported to the Principal Investigator and NextCell therefore does not have access to any study results. Once the results are reported to Professor Per-Ola Carlsson, they will be shared with NextCell without delay, after which the company will publish the topline results through a press release.