NextCell Pharma AB: 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.