Single treatment with ProTrans demonstrates long-term therapeutic effect over 5 years
NextCell Pharma AB ("NextCell" or the "Company") today announces that patients who were treated with a single dose of ProTrans five years ago in the randomized, placebo-controlled phase II study ProTrans-2 have retained significantly higher endogenous insulin production than patients who received placebo. ProTrans treated patients maintained 57% of their endogenous insulin production compared to 15% in the placebo group. The results are in line with NextCell’s previously reported three year data and demonstrates that ProTrans offers a disease-modifying treatment with long-lasting clinically relevant effect.
| ProTrans | Placebo | |
| 1 year | 89% (± 10%) | 53% (± 34%) |
| 2 years | 71% (± 21%) | 33% (± 26%) |
| 3 years | 63% (± 33%) | 23% (± 19%) |
| 4 years | 66% (± 41%) | 14% (± 12%) |
| 5 years | 57% (± 29%) | 14% (± 13%) |
Table 1: Maintenance of endogenous insulin production per year after a single infusion of ProTrans, mean value for each treatment arm + standard deviation.
NextCell's Chief Scientific Officer, Dr. Lindsay Davies, will present the data and explain how a single dose of ProTrans can provide such a long-lasting effect. The presentation will be available at https://www.redeye.se/events/1012070/nextcell-pharma from Wednesday 29 May at 09:00 CET.
In 2018, the randomized double-blinded phase II study ProTrans-2 started at Karolinska University Hospital. A total of 15 patients were randomized 2:1 for treatment with one infusion of ProTrans or placebo control. The primary endpoint was the percentage of retained endogenous insulin production capacity one year after treatment, with patients treated with ProTrans maintaining an average of 89% compared to placebo controls which maintained 53%.
The 14 patients who completed ProTrans-2 were invited, after completion of the study, to participate in a non-interventional follow-up study where they would be followed for an additional 5 years, ProTrans-Obs. In total 6 patients treated with ProTrans and 5 patients who received placebo completed the study. In ProTrans-Obs, the patients' endogenous insulin production capability was measured. ProTrans treatment demonstrated a statistically significant effect (p<0.05) compared to placebo.
No serious adverse reactions related to treatment have been reported. The company continues to analyses the data and will present more detailed results in the coming weeks.
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 28-05-2024 14:15 CET.