NextCell Pharma AB (“NextCell”) presented, in December 2019, efficacy data of ProTrans stem cells in an interim analysis of the ongoing phase I/II trial, ProTrans-1. Patients receiving medium or high dose of ProTrans showed a statistically significant effect as compared to low dose. The company will present data at Swiss Nordic Bio 2020, on February 6 in Zurich.
Swiss Nordic Bio is a partnering and investor conference aimed at connecting healthcare innovations, investors and industry. For NextCell this is an opportunity to inform international investors and potential collaborators about developments and future goals. NextCell has received funding and support from Vinnova and Business Sweden to attend the event.
NextCell Pharma is currently running two parallel trials with ProTrans for the treatment of patients with type 1-diabetes. The first trial is ProTrans-1, a two-part phase I/II trial design assessing the safety and efficacy of the study drug. In the first part, a dose escalation with three patients in 3 dose cohorts is used to evaluate the safety. An interim analysis of patients in the first part receiving medium or high dose of ProTrans showed a statistically significant effect as compared to low dose. The second part includes 15 patients that are randomized to active treatment or placebo (2:1 ratio), both patients and investigators are blinded. Topline data from the phase II part is expected to be available in the third quarter 2020.
The second clinical trial, ProTrans-Repeat, started in Maj 2019 and is a Phase IIa clinical trial that aims to evaluate whether repeated treatment can increase or maintain the effect of ProTrans over a longer period of time while maintaining safety. The effect is measured by comparing the patient’s ability to produce insulin before treatment, with twelve months after treatment with the repeated dose of ProTrans. This trial includes a maximum of eighteen patients, of which nine already received active treatment and the other patients will act as the control group. All patients receiving active treatment with ProTrans have previously been treated in the ProTrans-1 study’s dose escalation phase and are now about to receive repeated treatment in the ProTrans-Repeat trial. The patients in the control group have not, and will not, receive treatment with ProTrans, but are followed to compare the natural course of diabetes with how the disease develops during treatment with ProTrans.
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For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Sofia Fredrikson, CFO
Phone: 08-735 5595