NextCell Pharma AB ("NextCell" or "the Company") announces that the last patient in the older age cohort (12-21 years) of the clinical Phase II study, ProTrans-Young, has now completed their 12-month follow-up. The collected data is currently being compiled, and an administrative subgroup analysis is planned to be presented at the IDF World Diabetes Congress in Bangkok from April 7-10.
ProTrans-Young aims to evaluate the safety and efficacy of ProTrans, umbilical cord mesenchymal stromal cell treatment for newly-diagnosed type 1 diabetes in children and adolescents. The upcoming analysis represents an important interim readout of treatment response within the 12-21 year old age group. The purpose is to examine whether the treatment response in this age group follows the same trend as previously observed in adult patients. Results from the earlier ProTrans-T1D study in adults were published in 2023 in Diabetologia, the official journal of the European Association for the Study of Diabetes (EASD; Carlsson et al., 2023).
It is important to note that the analysis of this subgroup will not include in-depth statistical testing, such as significance assessment using p-values. This decision has been made to ensure the statistical integrity of the study. Repeated analyses within a study can increase the risk of false-positive results, which is typically managed by adjusting the significance level (alpha). However, such an adjustment can reduce the study's ability to detect true effects. To avoid this issue, the analysis is therefore limited to an overall trend assessment at this point.
Recruitment is ongoing for the younger age cohort in the ProTrans-Young study, children aged 7-11 years, with the goal of including all patients before the summer of 2025.
The study is being conducted in collaboration with Uppsala University under the leadership of Professor Per-Ola Carlsson, together with co-investigators Johnny Ludvigsson at Linköping University and Helena Elding Larsson at Lund University. Uppsala Clinical Research Center is responsible for data management.
For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 55 95
E-mail: info@nextcellpharma.com
Website:www.nextcellpharma.com
Linkedin: https://www.linkedin.com/NextCell-Pharma
Twitter: https://twitter.com/NextCellPharma
For more information about Cellaviva, please contact
Sofie Falk Jansson, CEO Cellaviva AB
Tel: +46 8 735 20 10
E-mail: info@cellaviva.se
Website:www.cellaviva.se
Facebook: https://www.facebook.com/cellavivasverige
Instagram: https://www,instagram.com/cellaviva
The company's shares are listed on the Nasdaq First North Growth Market. RedEye AB is assigned as Certified Adviser.
About NextCell Pharma AB
NextCell is a cell therapy company in Phase II trials with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to obtain market approval of ProTrans via a phase III trial. In addition to type 1 diabetes. NextCell owns Cellaviva AB, Scandinavia's largest private stem cell bank licensed by the Swedish Health Authority (IVO) to preserve and store stem cells from umbilical cord blood and umbilical cord tissue for family use. NextCell also owns QVance which will offer quality control analytics for advanced therapy developers. Furthermore, NextCell owns 8.5% in FamicordTX, a CAR-T start-up in oncology.
