The stem cell company NextCell Pharma AB (“NXTCL”) today announced that the Swedish Medical Product Agency has approved the amendment for treatment of patients in the ProTrans-1 trial with high dose of ProTrans in the randomized placebo-controlled part.
The ProTrans clinical trial is divided into a dose-scale part where 9 patients were treated with ProTrans during 2018. On October 25th, the Data Safety and Monitoring Board recommended the start of the second part of the trial with the dose that the study team found most appropriate.
The safety of ProTrans seem well tolerated, NXTCL therefore filed an application of an amendment to the Medical Products Agency to use high dose in the randomized, double-blinded, placebo-controlled part where 10 patients are treated with ProTrans and 5 patients with placebo. The aim is to measure the effect of treatment and results are expected in the first quarter of 2020.
NXTCL has previously announced the submission of another application, ProTrans-2 trial for repeated treatment with ProTrans. The application has been submitted and is handled by the Swedish Medical Products Agency, decision is expected first quarter of 2019.
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 16th of November 2018.
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