Press release from Companies
Publicerat: 2018-02-22 16:57:38
NextCell Pharma AB ("NXTCL") announces that three type 1 diabetes patients have been treated with ProTrans in the ongoing clinical phase I/II trial. Thus, all patients in the low-dose-cohort have now undergone treatment.
The trial performed with NXCTCL's patent-pending ProTrans, is divided into two parts, the first part being a doseescalation The second part of the trial is a randomized, double-blind, placebo-controlled trial in which 10 patients receive The clinical trial is conducted by the Karolinska Trial Alliance and headed by Professor Per-Ola Carlsson from Uppsala This information is the information that NextCell Pharma AB is required to disclose under the EU Market Abuse
phase with 3 + 3 + 3 patients being treated with either a; low, medium or high dose of ProTrans. Now
that all patients in the low-dose-cohort have been treated and after the 1-month follow-up is completed we can
start inclusion of patients in the medium-dose-cohort. The treatment and follow-up procedure are the same for the
middle-dose-cohort and high-dose-cohort.
ProTrans and 5 patients receive placebo, a total of 15 patients. In total 24 patients will be treated with ProTrans, 9
in the dose escalation part and another 15 in the placebo-controlled part. The primary safety endpoint is drug safety
and the primary efficacy endpoint is the change in insulin production after 1 year.
University, who is the principal investigator for the trial. The Data Safety Monitoring Board for the trial consists of
Professors Ulf Smith and Anders Fasth from the University of Gothenburg, and Åke Lernmark from Lund University.
Regulation. The information was provided by the below contact person for publication on February 22th, 2018.