NextCell Pharma AB (NextCell) announces that the initiation meeting for ProTrans-Repeat was held today at Karolinska University Hospital in Huddinge. ProTrans-Repeat is a completely independent trial and has no effect on the ProTrans-1 study. NextCell now has two ongoing clinical trials that run parallel and according to plan.
ProTrans-Repeat’s Principal investigator Professor Per-Ola Carlsson and the study team from Karolinska Trial Alliance, together with NextCell, went through the last practical details, which means that the new study has now been formally initiated. ProTrans-Repeat means that patients suffering from type 1 diabetes and who have previously participated in ProTrans-1, will receive repeated treatment with ProTrans.
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 longer period of time while maintaining safety. The effect is measured by comparing the patient’s ability to produce insulin before treatment, with twelve months after treatment with the repeated dose of ProTrans. This trial includes a maximum of eighteen patients, of which nine will receive active treatment and the other patients will act as the control group.
“Just last week we received the green light from the Medical Products Agency and now the trial is already starting today. Our study team is absolutely fantastic!”, Says Mathias Svahn, CEO of NextCell.
All patients receiving active treatment with ProTrans have previously been treated in the ProTrans-1 study’s dose escalation phase and are now about to receive repeated treatment in the ProTrans-Repeat trial. The patients in the control group have not, and will not, receive treatment with ProTrans, but are followed to compare the natural course of diabetes with how the disease develops during treatment with 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 17 May 2019.
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