NextCell Pharma AB (NextCell) announces that six out of the nine patients included in the dose escalation part of ProTrans-1, the trial with the drug candidate ProTrans, now have completed treatment and left the study.
Earlier this week, the last of the three patients in the so-called medium-dose-cohort visited for their 12-month follow-up, the final part of the trial, which means that all three now have completed their part of the trial. In early March, the three patients in the low-dose cohort had already completed the trial. This means that six out of nine patients in the phase I part have now successfully completed the trial.
ProTrans-1 is a phase I / II study in which the first part is a dose escalation with certainty as the primary endpoint. The dose escalation has been performed in three stages, from low dose to medium to high, with three patients in each dose cohort. All doses have been shown to be safe and do not cause any side effects. After a 12-month follow-up visit, the patient leaves the study. Currently, the patients in the low- and middle-dose cohort have left the study while the patients in the high-dose cohort are expected perform their follow-up visits in September / October this year.
The patients who participated in the ProTrans-1 study will be asked to be included in the new ProTrans-Repeat trial, a stand-alone continuation trial expected to begin shortly.
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