Pediatric diabetes trial with ProTrans gets green light for phase II part
NextCell Pharma AB ("NextCell") announces that the Data Safety Monitoring Board has recommended professor Per-Ola Carlsson to continue with the phase II part of the pediatric study in type-1 diabetes with ProTrans, ProTrans-Young.
The first part of ProTrans-Young is a safety part (phase Ib) where all patients are treated at Uppsala University Hospital. 3 patients aged 12-18 years first receive treatment and are then followed by 3 patients aged 7-11 years. After all 6 patients have been on a 3 month follow-up examination, there is a review of data with regards to safety by the Data Safety Monitoring Board (DSMB). The DSMB has now recommended that the study continues with a second part which is randomized and placebo-controlled (phase II). A total of 60 children and adolescents with type-1 diabetes will be treated, 30 with ProTrans and 30 with placebo. Initially, 30 patients aged 12-21 in Part II will be treated and after 6 months of follow-up, the DSMB will review safety before continuing to treat the remaining 30 patients aged 7-11.
The principal investigator is professor Per-Ola Carlsson, Uppsala University and Uppsala University Hospital with co-investigators Professor Helena Elding Larsson, Skåne Universitety Hospital and Professor Johnny Ludvigsson, Linköping Universitets Hospital. The Data Safety Monitoring Board consists of chairman professor Ulf Smith, Sahlgrenska and Professor Mikael Rydén, Karolinska University Hospital and Professor Anders Fasth, Queen Silivia's Children's Hospital.
Uppsala University Hospital is the sponsor of the trial, which is funded by research grants. NextCell contributes to the study with ProTrans and placebo. In addition, the company will support the trial with logistics, documentation, and expert competence. No additional monetary compensation will be paid, i.e., NextCell will not pay for the study.
The full title of the study is: "A Double-blinded, Randomized, Parallel, Placebo-controlled trial of Wharton's Jelly-derived Allogeneic Mesenchymal Stromal Cells to treat Type I Diabetes in Children and Adolescents" (EudraCT 2020-004520-42).
This disclosure contains information that NextCell Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 28-10-2022 11:10 CET.
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About NextCell Pharma AB
NextCell is a cell therapy company in clinical phase II. The company has developed a proprietary and patented platform technology to produce mesenchymal stem cells adapted for allogeneic treatment of various autoimmune and immunological diseases. The drug candidate ProTrans is now being tested for the treatment of type-1 diabetes as well as respiratory complications caused by Sars-CoV-2 infection. The focus is to take ProTrans to a market approval for type-1 diabetes via a phase III study. ProTrans is evaluated in two clinical Covid-19 studies, in Sweden and Canada. NextCell is working on completing its own GMP facility for the manufacture of ProTrans. The GMP facility is expected to be ready for manufacturing smaller quantities of ProTrans in 2023. NextCell also owns 8.5% of FamicordTX, a start-up company in CAR-T ‘and oncology, and 100% of Cellaviva, Scandinavia's largest stem cell bank for family savings of stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).