NextCell's phase II study is completed – a phase III is being prepared
NextCell Pharma AB ("NextCell") announces that the last patient now has left ProTrans-2, meaning the phase II trial with the drug candidate ProTrans for treatment of type 1 diabetes, is completed according to plan. Data will be compiled and analyzed by independent statistician to be presented during the third quarter.
“NextCell is now preparing a phase III trial in order to reach the market as soon as possible, in case of a positive result of the phase II study”, says Mathias Svahn, CEO.
NextCell's drug candidate, ProTrans ™, developed for the treatment of type 1 diabetes, has, in addition to a successfully completed safety evaluation, shown initial effect in protecting the patient's own insulin production. NextCell is conducting a total of three * clinical trials with ProTrans ™, ProTrans-1, ProTrans-2 and ProTrans-Repeat. ProTrans-2 is placebo-controlled and double-blinded, which means that patients are randomized to ProTrans or placebo for the treatment of type-1 diabetes. Neither patients nor doctors know if the patient received ProTrans or placebo.
ProTrans-1
Started in January 2018 and was a phase I trial, evaluating ProTrans ™ safety and impact on the patient's own insulin production. The study included a total of nine patients, treated with low, medium and high dose. Results of the study were published on December 4, 2019 and showed, in addition to the primary purpose; safety, also a statistically significant difference in own insulin production between the different patient groups. The patients in the high and medium dose cohort had maintained a higher insulin production compared to the patients in the low dose cohort.
ProTrans-2
Is a randomized, double-blind and placebo-controlled phase II trial in which ten patients receive ProTrans ™ and five patients receive placebo. The purpose is to demonstrate the effect of ProTrans. The last patient in ProTrans-2 was treated in June 2019 and results are expected to be available in the third quarter of 2020. The study is thus completed, according to the timetable. Of the total 15, 14 patients have completed the study.One patient chose to leave the study early due to reasons that cannot be related to the study.
ProTrans-Repeat
Started in May 2019 and is a direct continuation of ProTrans-1/2 with the aim of obtaining data on repeated treatment, i.e. evaluating whether repeated treatment can increase or maintain any potential effect of ProTrans ™ over a longer period of time with retained safety. The study includes the nine patients treated in the ProTrans-1 study's dose escalation section as well as another six to nine patients as a control group. The efficacy is measured by comparing the patient's ability to produce insulin before treatment with 12 months after treatment with the repeated dose of ProTrans ™. Patients are followed for five years after treatment is completed. The last patient was treated in September 2019 and results are expected to be available by the end of 2020.
* The short names of the clinical trials have been changed for the purpose of simplification. Instead of specifying ProTrans-1 as a phase I / II study in two parts, the two parts are referred to as ProTrans-1 and ProTrans-2 respectively.
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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.