Patients in the first part of pediatric diabetes trial with NextCell’s ProTrans treated

June 8, 2022

The cell therapy company NextCell Pharma AB ("NextCell") today announces that all six children in the first part of the study have now been treated with ProTrans. Patients will be monitored during the summer after which the safety of treatment will be evaluated by an independent Data Safety and Monitoring Board.

The first part of the clinical trial with Protrans is a safety part where all patients are children with type-1 diabetes who have now received their treatment at the Uppsala University Hospital. The Data Safety and Monitoring Board consists of Professor Ulf Smith, Sahlgrenska University Hospital, Professor Mikael Rydén, Karolinska Hospital and Professor Anders Fasth, Queen Silvia Children's Hospital. They will evaluate whether it is safe to proceed to the phase II part of the study, based on 3 months of follow-up of six children.

In the phase II part of the study, patients are randomized to ProTrans or placebo (1:1). First, 30 patients in the age group of 12-21 years are treated, after which - provided the recommendation of the Data Safety and Monitoring Board after six months -, another 30 patients in the age group of 7-11 years are included in the study. ProTrans is a cell therapy that balances the immune system and counteracts autoimmune type-1 diabetes. The active substance mesenchymal stromal cells, also called stem cells, are selected from umbilical cord tissue using NextCell's patent-pending selection algorithms.

The principal investigators for the study are professor Per-Ola Carlsson, Uppsala University and Uppsala University Hospital with the co-investigators professor Helena Elding Larsson, Skånes University Hospital and professor Johnny Ludvigsson, Linköpings University Hospital. The second part of the study is randomized and placebo-controlled (phase II) and a total of 60 children and adolescents with type-1 diabetes will be treated, of which 30 with ProTrans and 30 with placebo. Recruitment will take place at the three participating hospitals in Uppsala, Linköping and Malmö.

Uppsala University Hospital is the sponsor of the study, which is funded by research grants. NextCell contributes with ProTrans and placebo. In addition, the company will support the trial with logistics, documentation and cell therapy expertise.

Full name of the study is: “A Double-blinded, Randomized, Parallel, Placebo-controlled trial of Wharton´s Jelly-derived Allogeneic Mesenchymal Stromal Cells to treat Type I Diabetes in Children and Adolescents” (EudraCT 2020-004520-42).

For more information about NextCell Pharma AB, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: 08-735 5595
E-mail: info@nextcellpharma.com

Websites:
www.nextcellpharma.com
www.cellaviva.se
www.cellaviva.dk
LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma
Instagram: https://www.instagram.com/cellaviva/

Certified Adviser
‍FNCA Sweden AB is assigned as Certified Adviser, 08-528 00 399, info@fnca.se.

About NextCell Pharma AB
NextCell is a phase II cell therapy company with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to take ProTrans to market approval via a Phase III study. ProTrans is in addition to diabetes, used in two clinical trials for Covid-19, in Örebro and Montreal (Canada). The company is in the processes of establishing its own GMP facility for production of ProTrans. The GMP facility is expected to be ready for production of smaller quantities of ProTrans in 2023. NextCell furthermore owns 8,5% in FamicordTX, a CAR-T start-up in oncology and 100% of Cellaviva, Scandinavia's largest stem cell bank for family saving stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).

Download attachment Read full press release on Cision (external link)

2020-12-16

NextCell Pharma publishes prospectus supplement

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, HONG KONG, JAPAN, CANADA, NEW ZEALAND, SOUTH AFRICA, SWITZERLAND, SINGAPORE OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. The Board of Directors of NextCell Pharma AB ("NextCell" or the “Company”) has prepared a supplement to the prospectus regarding the invitation to subscribe for shares in the Company’s resolved rights issue, which was approved by the Swedish

Read more Read more

2020-12-15

ProTrans Observation Study for long term efficacy in diabetes

NextCell Pharma AB (“NextCell” or “the Company”) today announces that an observational study, ProTrans-OBS, has been approved by the Swedish Ethical Review Board for long-term follow-up of patients previously participating in the ProTrans-2 clinical trial. The study is conducted by professor Per-Ola Carlsson, at Uppsala University. The observational study, ProTrans-OBS, is a non-interventional study, i.e. patients will not be treated with additional doses of ProTrans. Participants that completed the ProTrans-2 trial will be asked for informed consent for biannual clinical assessment of

Read more Read more

2020-12-10

ProTrans demonstrates effect at 2 years after repeated treatments

NextCell Pharma AB ("NextCell") today announces that the ProTrans-Repeat trial met its primary safety endpoint. There were no severe adverse events recorded during the 12-month follow-up period after a second dose of ProTrans™ (ProTrans). Furthermore, a strong tendency of sustained efficacy was observed in the three patients receiving high dose ProTrans. · Primary safety endpoint met · Tendency of sustained efficacy observed for high dose patients · 2-year preservation of insulin production significantly higher for patients treated with high dose as compared to low dose ProTrans-

Read more Read more

2020-12-03

NextCell Pharma publishes prospectus relating to the rights issue

The Board of Directors of NextCell Pharma AB ("NextCell" or the “Company”) has prepared a prospectus (the “Prospectus”) relating to the new issue of shares with preferential rights for existing shareholders of approximately SEK 150 million (the Rights Issue”), which was resolved by the Board of Directors on 26 November 2020 pursuant to the authorisation from the annual general meeting. The Prospectus has today been approved and registered by the Swedish Financial Supervisory Authority. NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE

Read more Read more

2020-11-20

The Board of Directors of NextCell Pharma intends on resolving on a fully guaranteed preferential rights issue of approximately SEK 150 million

The Board of Directors of NextCell Pharma AB (“NextCell” or the “Company”) today announces its intention to resolve on a fully guaranteed rights issue of up to approximately SEK 150 million with preferential rights for the Company’s existing shareholders (the “Rights Issue”). The Board of Directors’ intent to resolve on the Rights Issue requires that the shareholders at the Annual General Meeting on 24 November 2020 authorizes the Board of Directors to resolve on share issues. In the notice convening the Annual General Meeting, which was published by press release on 23 October 2020, the

Read more Read more

2020-11-16

NextCell supports ProTrans study for children and adolescents

NextCell Pharma AB (“NextCell”) has entered into an agreement with Professor Per-Ola Carlsson, at Uppsala University Hospital and Uppsala University, with the aim of contributing the stem cell product ProTrans™ (ProTrans) for the treatment of children and adolescents with type 1 diabetes, within the framework of clinical drug trials. The study, which is in the planning stage, is part of NextCell's strategy to support academic groups with drugs to be able to evaluate ProTrans for a wider use. NextCell's drug candidate, ProTrans, for the treatment of type 1 diabetes is a mesenchymal stem cell

Read more Read more

2020-11-09

NextCell has formally kicked-off its Eurostars funded project ‘ Bioscale ’

NextCell Pharma AB (“NextCell” or the “Company”) announces today that it, in cooperation with the consortium members: MyCellHub, SEFA and Scinus Cell Expansion, now officially has kicked-off the earlier announced Eurostars project. The Eurostars project Bioscale will focus on using a novel cell expansion system developed by Scinus Cell Expansion, to further test, develop and validate the involved bioprocesses used in the production of NextCell’s drug candidate ProTrans™ (ProTrans). · NextCell has been granted €470,000 of a Eurostar grant totalling €1.6M. The total budget of the project is €2.

Read more Read more

2020-10-30

NextCell publishes its Year-End Report

NextCell Pharma AB (publ) (NXTCL) publishes its Year-End Report for the period September 1, 2019 - August 31, 2020 The report is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report NextCells share is traded on Nasdaq First North Growth Market under the ticker "NXTCL". The amount in brackets refers to the corresponding period in the previous year. Twelve months (2019-09-01 until 2020-08-31) ● Operating income amounted to SEK 4 166 123 (1 964 132). ● Operating result amounted to SEK -17 680 697 (-17 997 787). ● Earnings per share* amounted

Read more Read more