NextCell´s publication of the phase I/II clinical trial in type I diabetes accepted

March 28, 2023

NextCell Pharma AB (”NextCell” or ”Company”) have had their article detailing the results of their phase I/II clinical trial in type I diabetes accepted in the peer-reviewed journal Diabetologia.

NextCell Pharma AB (”NextCell” or ”Company”) have had their article detailing the results of their phase I/II clinical trial in type I diabetes accepted in the peer-reviewed journal Diabetologia.

NextCell Pharma AB is a cell therapy company working in the development and commercialization of the mesenchymal stromal cell therapy product, ProTrans. This product, with its proprietary platform technology, is in clinical development for the treatment of autoimmune conditions, such as type I diabetes and inflammatory conditions such as viral pneumonia.

 

NextCell´s seminal study in type 1 diabetes, with their advanced therapeutic medicinal product, ProTrans, has been accepted for publication in the journal Diabetologia. The article, entitled, “Umbilical Cord-Derived Mesenchymal Stromal Cells Preserve Endogenous Insulin Production in Type 1 Diabetes: a Phase I/II Double-blinded, Placebo-controlled, Randomized trial” details how a single infusion of ProTrans can maintain the endogenous production of insulin, slowing the progression of the disease.

 

“It is fantastic to have our first study in type I diabetes published. This study has been the foundation for our clinical development programme in type I diabetes. The study, although small, presents strong data indicative of the effectiveness of ProTrans treatment in slowing diabetic disease development. Based on these data we have moved forward with a pediatric study investigating the efficacy of our drug product in newly diagnosed type I diabetics in the 7-21 age range, ”says Dr Mathias Svahn, CEO for NextCell Pharma.

 

The data reported in the manuscript was generated in collaboration with Professor Per-Ola Carlsson, Principal Investigator at Uppsala University and Karolinska Trial Alliance, Karolinska University Hospital, Huddinge, Sweden(Clinicaltrials.gov identifier NCT03406585).

 

For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel:08-735 5595
E-mail: info@nextcellpharma.com
Website: www.nextcellpharma.com
 LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma
 
 
 
About NextCell Pharma AB
NextCell is a celltherapy company in clinical phase II. The company has developed a proprietary and patented platform technology to produce mesenchymal stromal cells adapted for allogeneic treatment of various autoimmune and immunological diseases. The drug candidate ProTrans is now being tested for the treatment of type-1 diabetes as well as respiratory complications caused by Sars-CoV-2 infection. The focus is to take ProTrans to market approval for type-1 diabetes via a phase III study. ProTrans is evaluated in two clinical COVID-19 studies, in Sweden and Canada. NextCell is working on completing its own GMP facility for the manufacture of ProTrans. The GMP facility is expected to be ready for manufacturing smaller quantities of ProTrans in 2023. NextCell also owns 8.5%of FamicordTX, a start-up company in CAR-T and oncology, and 100% of Cellaviva, Scandinavia's largest stem cell bank for family savings of stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).

 

For more information about NextCell Pharma AB, please contact

Mathias Svahn, CEO
Patrik Fagerholm, CFO

Tel:08-735 5595
E-mail: info@nextcellpharma.com

Website: www.nextcellpharma.com

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

Twitter: https://twitter.com/NextCellPharma

About NextCell Pharma AB

NextCell is a celltherapy company in clinical phase II. The company has developed a proprietary and patented platform technology to produce mesenchymal stromal cells adapted for allogeneic treatment of various autoimmune and immunological diseases. The drug candidate ProTrans is now being tested for the treatment of type-1 diabetes as well as respiratory complications caused by Sars-CoV-2 infection. The focus is to take ProTrans to market approval for type-1 diabetes via a phase III study. ProTrans is evaluated in two clinical COVID-19 studies, in Sweden and Canada. NextCell is working on completing its own GMP facility for the manufacture of ProTrans. The GMP facility is expected to be ready for manufacturing smaller quantities of ProTrans in 2023. NextCell also owns 8.5%of FamicordTX, a start-up company in CAR-T and oncology, and 100% of Cellaviva, Scandinavia's largest stem cell bank for family savings of stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).

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THIS PRESS RELEASE MAY NOT BE RELEASED, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND, CANADA, HONG KONG, BELARUS, RUSSIA OR IN ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLISHING OR DISTRIBUTION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTATION OR OTHER MEASURES IN ADDITION TO THOSE REQUIRED BY SWEDISH LAW. SEE SECTION ”IMPORTANT INFORMATION” AT THE END OF THIS PRESS RELEASE. NextCell Pharma AB (publ) ("NextCell" or the "Company") announces that the Company has agreed to a so-called top guarantee of a total of approximately SEK 8.0 million, corresponding to approximately 20.0 percent of the transaction, from qualified investors in the Company's ongoing rights issue of units of up to approximately SEK 40.1 million before issue costs, in which the subscription period commenced on 31 May 2024 (the "Rights Issue"). With the addition of the top guarantee, the Rights Issue is now covered up to approximately 100 percent by subscription undertakings and guarantee commitments.
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THIS PRESS RELEASE MAY NOT BE RELEASED, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND, CANADA, HONG KONG, BELARUS, RUSSIA OR IN ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLISHING OR DISTRIBUTION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTATION OR OTHER MEASURES IN ADDITION TO THOSE REQUIRED BY SWEDISH LAW. SEE SECTION ”IMPORTANT INFORMATION” AT THE END OF THIS PRESS RELEASE. NextCell Pharma AB (publ) (”NextCell” or the “Company”) has prepared an EU Growth prospectus (the “Prospectus”) in connection with the Company’s forthcoming issue of units consisting of shares and warrants with preferential rights for existing shareholders (the “Rights Issue”), which was resolved by the Board of Directors on 24 April 2024 and approved by the Extraordinary General Meeting on 27 May 2024.
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