ProTrans-Repeat, an approved clinical trial for repeated treatment of patients with diabetes

The Medical Products Agency has granted NextCell Pharma AB ("NextCell") permission to conduct the new study, ProTrans-Repeat. The study is a continuation of ProTrans-1 where patients with type-1 diabetes who participated in the dose escalation part will be asked to participate in ProTrans-Repeat. The purpose is to investigate whether repeated treatment is safe and gives increased effect on the patient's ability to produce insulin.

ProTrans-Repeat 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 approval of the study is a milestone for NextCell, which is now a step closer to its vision of treating patients with autoimmune diseases. The rate of development is increased by repeated treatment being evaluated in parallel with the placebo-controlled study, ProTrans-1. The cost of conducting ProTrans-Repeat is also expected to be considerably lower compared to ProTrans-1, since sufficient investigational product has already been produced and that there is experience and routines for treatment with ProTrans.

"ProTrans-Repeat, will give us valuable data on repeated treatments. Safety results from ProTrans-1 enable us to move forward quickly in our clinical development” says Mathias Svahn, CEO of NextCell.

In addition to the nine patients who will receive active treatment, nine patients are planned to be included as control patients, which means that they are followed in the same way as the others but without undergoing treatment. The effect is measured by comparing the patient's ability to produce insulin before treatment with 12 months after treatment with the repeated dose of ProTrans.

The official study title is "An open label, parallel single center trial of Wharton's jelly derived allogeneic mesenchymal stromal cells repeatedly treated to preserve endogenous insulin production in adult patients diagnosed with type 1 diabetes". The study is carried out in collaboration with Karolinska Trial Alliance at Karolinska University Hospital in Huddinge and the principle investigator Professor Per-Ola Carlsson.

At the last visit to the ongoing study ProTrans-1, patients from the dose escalation study will be asked if they are willing to participate in ProTrans-Repeat, ie. the last visit to ProTrans-1 is anticipated to be the first visit to ProTrans-Repeat (provided patients consent). However, this does not apply to patients in the low-dose cohort who will be asked afterwards since they have already left ProTrans-1.

The first part of the ongoing study ProTrans-1 is a dose escalation study in which a total of nine patients were treated with ProTrans, three with low dose, three with mean dose and another three with high dose. The patients were then followed for 12 months and the three patients included in the low-dose cohort left the study at the end of February after having been on the 12-month follow-up. The patients in the middle and high dose cohorts are planned to make their follow-up visits in May and October 2019 respectively.

Furthermore, the second part of the ProTrans-1 study has included patients who are a randomized, double-blind, placebo-controlled study in ten patients receiving ProTrans and five patients receiving placebo. The last patient is expected to be completed in mid-2020 and will thus run in parallel with ProTrans-Repeat.

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LinkedIn: https://www.linkedin.com/company/15255207/

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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

www.nextcellpharma.com

About NextCell Pharma AB:

Stem cells are expected to change the way how many of today's life-threatening diseases are treated. NextCell Pharma AB develops ProTrans, a drug candidate consisting of stem cells for the primary treatment of autoimmune and inflammatory diseases as well as for use in kidney transplants. ProTrans consists of selected stem cells derived from the umbilical cord tissue with NextCell Pharma AB's proprietary method. In addition, the company has a service called Cellaviva, Sweden's first and only IVO-approved stem cell bank for the family-saving of stem cells from umbilical cord blood and umbilical cord tissue.

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