Cellaviva's parent company
NextCell Pharma AB ("NextCell") today announces that the ProTrans-2 clinical trial met the primary endpoint.
Patients treated with a single dose ProTrans show a statistically significant improved preservation of insulin production over 12 months, compared to patients treated with placebo (p-value < 0.05).
A total of 15 patients were included in the ProTrans-2 trial. They were randomized to receive either ProTrans (n=10), NextCell’s proprietary stem cell therapy, or placebo (n=5). Treatment was blinded, ensuring that neither patients or their physicians knew whether they had received active treatment or placebo during the 12-month follow-up. After all data had been compiled and monitored by Karolinska Trial Alliance, the code was broken, and the results reviewed by Medical Statistics Unit, Karolinska Instituet.
To evaluate if ProTrans can improve beta cell function (endogenous insulin production capacity) in adult type-1 diabetes patients diagnosed within the last two years, C-peptide was measured during two hours after a Mixed Meal Tolerance Test (MMTT). The primary efficacy endpoint in ProTrans-2 was defined as delta-change of C-peptide Area Under the Curve (AUC) for MMTT, at day 372, following ProTrans/placebo infusion when compared to baseline performance prior to treatment. In other words, measuring the patient’s percentage of insulin production remaining after 1 year.
C-peptide levels in placebo patients declined by -47 % (from average 48 nmol/l x 120 min, [SD=26] at baseline to 30 nmol/l x 120 min, [SD=26] at 12 months), whereas ProTrans treated patients declined with -10% (from average 96 nmol/l x 120 min, [SD=34] at baseline to 85 nmol/l x 120 min, [SD=30] at 12 months). ProTrans treated patients had a significant improvement in insulin preservation compared to placebo treated patients (p<0.05).
“Allogeneic cell therapy has again shown an effect in type-1 diabetes. This time in a randomized controlled trial”, says the principal investigator Professor Per-Ola Carlsson, Uppsala University and Uppsala University Hospital.
A short presentation of the results in Swedish will be given today at 14:30 (slides in and possibility to ask questions in English). Welcome to Financial Hearings at: https://tv.streamfabriken.com/2020-09-08-press-conference or dial-in on; SE: +46856642705, UK: +443333009260, US: +18332498406.
On Thursday the 10th of September at 16:00, Professor Carlsson and the NextCell team invites you to a webcast presentation of the results and the roadmap forward for ProTrans in type-1 diabetes. The presentation is hosted by Directed Studios and can be watched at: https://youtu.be/HzV8T2kpdGI.
“Exciting results. 2 of 9 patients treated with ProTrans had increased insulin production after 1 year and in total 4 of 10 had a decrease of 5 % or less, as compared to 0 of 5 patients receiving placebo”, says Mathias Svahn, CEO NextCell Pharma, AB.
Area under the curve C-peptide based on a mixed meal tolerance test (MMTT) is the gold standard measure of beta cell loss in type-1 diabetes. There were signficicant differences in endogeounus insulin production between the groups at baseline. The per protocol statistical analysis of changes in C-peptide levels were calculated in percentage. Two-sample t-test (two-tailed with equal variance) was used for p-value calculation, p=0.011. At this point, only primary endpoints have been analysed and more data will be presented when available.
A short presentation of the results in Swedish will be given today at 14:30 (slides in and possibility to ask questions in English). Welcome to Financial Hearings at: https://tv.streamfabriken.com/2020-09-08-press-conference or dial-in on; SE: +46856642705, UK: +443333009260, US: +18332498406.
On Thursday the 10th of September at 16:00, Professor Carlsson and the NextCell team invites you to a webcast presentation of the results and the roadmap forward for ProTrans in type-1 diabetes. The presentation is hosted by Direkt Studios and can be watched at: https://youtu.be/HzV8T2kpdGI.
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 8th of September 2020.
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For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Sofia Fredrikson, CFO
Phone: 08-735 5595
E-mail: info@nextcellpharma.com
Website:
www.nextcellpharma.com, www.cellaviva.se
www.cellaviva.dk
About NextCell Pharma AB
NextCell is a Phase II cell therapy company with the lead candidate ProTrans™, for the treatment of type-1 diabetes. Focus is to take ProTrans™ to market approval via a phase III study. Furthermore, NextCell operates Cellaviva, Scandinavia’s largest stem cell bank for family-saving of stem cells from umbilical cord blood and umbilical cord tissue with permission from IVO. FNCA Sweden AB is assigned as Certified Adviser, 08-528 00 399, info@fnca.se.
