NextCell Pharma AB (“NextCell”) today received a permit from the Medical Products Agency granting permission to initiate a new clinical trial, called ProTrans-Repeat. The trials is a continuation of the ongoing ProTrans-1 trial and of great importance to the further development of ProTrans. The goal for this study is to include those patients with type 1 diabetes who participated in the dose escalation part of the ongoing ProTrans-1 study and the study purpose is to demonstrate that ProTrans also has a positive effect when using a repeated treatment approach.
ProTrans-Repeat is a Phase IIa clinical trial that aims to evaluate whether repeated treatment can increase or maintain the effect of ProTrans over a long period of time while maintaining safety. In addition to the nine patients who will receive active treatment, nine patients are planned to be included as control patients, which means that they are followed in the same way as the others but without undergoing treatment. The effect is measured by comparing the patient’s ability to produce insulin before treatment with 12 months after treatment with the repeated dose of ProTrans.
This information is the information that NextCell Pharma AB is required to disclose under the EU Market Abuse Regulation. The information was provided by the below contact person for publication on 8th of May 2019.
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