ProTrans cell therapy provides long-term effect in type-1 diabetes with a single treatment
NextCell Pharma AB ("NextCell" or the "Company") today announces that patients who 3 years ago were treated with ProTrans in the phase II study ProTrans-2 have maintained significantly higher endogenous insulin production than patients who received placebo, (63% compared to 23%). The results from the interim follow-up study ProTrans-Obs suggest that the treatment changes the course of the disease and that the effect persists over time.
In 2018, the randomized double-blind phase II clinical trial, ProTrans-2 started at Karolinska University Hospital. A total of 15 patients were randomized 2:1 to treatment with ProTrans or placebo. The primary endpoint is percentage of endogenous insulin production one year after therapy and patients treated with ProTrans maintained an average of 90% compared to the placebo group who maintained 53%.
The 14 patients who completed ProTrans-2 were after completion offered to participate in a follow-up study, where they are followed for another 5 years, ProTrans-Obs. Some patients abstained from participation due to long journeys, 6 patients treated with ProTrans and 5 patients who received placebo are included in the study. In ProTrans-Obs, the patients' endogenous insulin production is measured semi-annually and the latest analysis was carried out after 3 years of follow-up. In this interim analysis, ProTrans shows a statically significant treatment effect at all analyzed time points (p<0.05).
| ProTrans | Placebo | |
| 1 year | 89% | 53% |
| 2 year | 71% | 33% |
| 2,5 year | 69% | 30% |
| 3 year | 63% | 23% |
NextCell announced on October 18, 2022 that patients with type-1 diabetes undergoing two high-dose treatments of ProTrans cell therapy retain significantly higher endogenous insulin production than patients treated with low and medium dose in the clinical drug trial, ProTrans-Repeat. The results from ProTrans-Obs (one treatment with ProTrans) and ProTrans-Repeat (two treatments with ProTrans) cannot be directly compared, but both studies clearly show that ProTrans has a long-term effect for the treatment of type-1 diabetes.
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 20-10-2022 13:30 CET.
For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 5595
E-mail: info@nextcellpharma.com
Websites:
NextCell Pharma AB: www.nextcellpharma.com
Cellaviva Sverige: www.cellaviva.se
Cellaviva Danmark: www.cellaviva.dk
LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma
Certified Adviser
FNCA Sweden AB is assigned as Certified Adviser, 08-528 00 399, info@fnca.se.
About NextCell Pharma AB
NextCell is a phase II cell therapy company with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to take ProTrans to market approval via a Phase III study. ProTrans is in addition to diabetes, used in two clinical trials for Covid-19, in Örebro and Montreal (Canada). The company is in the processes of establishing its own GMP facility for production of ProTrans. The GMP facility is expected to be ready for production of smaller quantities of ProTrans in 2023. NextCell furthermore owns 10% in FamicordTX, a CAR-T start-up in oncology and 100 % of Cellaviva, Scandinavia's largest stem cell bank for family saving stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).