The paediatric diabetes study gets the green light to treat the age group 7 – 11 years

June 12, 2024

NextCell Pharma AB (publ) ("NextCell") announces that the Data Safety Monitoring Board for the ProTrans-Young study has recommended the principal investigator, Professor Per-Ola Carlsson, to continue with treatment of children in the younger age group 7 – 11 years. This decision is based on a review of all available safety data from the 36 children and adolescents who have participated in the study so far. The recruitment of the 30 children aged 7-11 will begin in August 2024.

The first part of the ProTrans-Young study is a safety part (phase Ib) where all 6 patients aged 7-18 years are treated with ProTrans. 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. The first 30 patients aged 12-21 have undergone treatment and been on follow-up visits for at least 3 months. The Data Safety Monitoring Board has now reviewed the safety and recommended that the study continue with treatment of the remaining 30 patients aged 7-11.

Information in Swedish about the clinical trial and participation can be found at: https://www.nextcellpharma.com/studie

Treatment with ProTrans aims to stop the autoimmune destruction of insulin-producing cells. The children and adolescents in ProTrans-Young are treated with ProTrans within 6 months of being diagnosed with type-1 diabetes. The purpose is to be able to maintain as much of their insulin production as long as possible, even if they will continue to need extra insulin. The body's own insulin production buffers blood sugar and reduces the risk of fluctuations that can lead to serious complications.

A subgroup analysis of the treatment effect of ProTrans in 30 adolescents in the age group 12-21 years, is expected to be presented in April 2025. The measure of effectiveness is the difference in endogenous insulin production between ProTrans and placebo-treated patients one year after treatment. Topline results from the entire study are expected by the end of 2026. Previous studies with ProTrans have been limited to adults, therefore only children under 18 years of age are included in the first part of the study. The other part is divided into two age groups that are commonly used in clinical trials in type 1 diabetes, 7-11 and 12-21 years respectively.

The principal investigators are Professor Per-Ola Carlsson, Uppsala University and Uppsala University Hospital, with the co-investigators Professor Helena Elding Larsson, Skåne University Hospital and Professor Johnny Ludvigsson, Linköping University Hospital. The Data Safety Monitoring Board consists of Chairman Professor Ulf Smith, Sahlgrenska and Professor Mikael Rydén, Karolinska and Professor Anders Fasth, Queen Silivia Children's Hospital.

The complete title of the clinical trial 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).

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

For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 55 95
E-mail: [email protected]
Website:www.nextcellpharma.com

Linkedin: https://www.linkedin.com/NextCell-Pharma
Twitter: https://twitter.com/NextCellPharma


For more information about Cellaviva, please contact
Sofie Falk Jansson, Head of Cellaviva
Tel: +46 8 735 20 10
E-mail: [email protected]
Website:www.cellaviva.se


Facebook: https://www.facebook.com/cellavivasverige
Instagram: https://www,instagram.com/cellaviva

Certified Adviser
FNCA Sweden AB is assigned as Certified Adviser.

About NextCell Pharma AB

NextCell is a cell therapy company that is in phase 2 studies with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to obtain market approval of ProTrans via a phase 3 study. ProTrans is manufactured utilizing the patented platform technology for selection of optimal cells with potency to treat inflammatory disorders including autoimmune diseases. NextCell owns Cellaviva, the largest stem cell bank in the Nordics and QVance, a quality analysis CRO company in start up.

Download attachmentRead full press release on Cision (external link)
2024-10-08
NextCell Pharma invited to present in Tokyo
NextCell Pharma AB's* CEO, Mathias Svahn, has been invited by Business Sweden to the Swedish Embassy in Tokyo, to present the company’s ongoing development at an event on October 8, 2024. The event will focus on innovations in AI and healthcare, where Swedish and Japanese stakeholders will gather to discuss how future healthcare solutions can be developed through collaboration.
Read moreRead more
2024-10-04
ProTrans highlighted as a promising treatment for type 1 diabetes in Dagens Medicin
NextCell Pharma AB* is proud that their drug candidate ProTrans has been highlighted in Dagens Medicin’s latest edition featuring ongoing research advances in the treatment of type 1 diabetes. ProTrans consists of mesenchymal stromal cells from the umbilical cord and has been investigated in a number of clinical studies at Uppsala University Hospital, where its potential to slow down the progression of the disease has been demonstrated.
Read moreRead more
2024-10-01
The first children have been treated in the younger age group of the ProTrans-Young study
NextCell Pharma AB ("NextCell" or the "Company", Nasdaq First North Growth Market: NXTCL), announces that the first four children in the 7–11 year age group have been treated in the latest phase of the ProTrans-Young study. An additional four children have been screened and are expected to begin their treatment shortly. These advancements mark an important milestone in the progress of the study, which is proceeding faster than anticipated.
Read moreRead more
2024-09-05
Broader health benefits of ProTrans in treatment of type 1 diabetes
NextCell Pharma AB ("NextCell" or the "Company", Nasdaq First North Growth Market: NXTCL), has presented new long-term clinical data at the International Society for Cell and Gene Therapy (ISCT) 2024 Regional Meeting, held in Gothenburg, Sweden. The results show the long-term safety of the treatment, the effect of preserving the patient's own insulin production and more health benefits in patients with type 1 diabetes (T1D), such as lower BMI and blood pressure.
Read moreRead more
2024-09-03
CSO Lindsay Davies Co-Chairs ISCT Europe 2024 Meeting
NextCell Pharma AB ("NextCell" or the "Company", Nasdaq First North Growth Market: NXTCL), a leader in advanced cell therapy and immunotherapy research, is proud to announce that Dr. Lindsay Davies, the company’s Chief Scientific Officer (CSO) and ISCT Europe Regional Secretary, serves as Co-Chair together with Dr. Massimiliano Gnecchi of the International Society for Cell and Gene Therapy (ISCT) 2024 Regional Meeting, held in Gothenburg, Sweden, from September 4-6.
Read moreRead more
2024-07-25
NextCell publishes its Interim Report 3 2023/2024
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 3 for the period September 1, 2023 – May 31, 2024. 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.
Read moreRead more
2024-07-03
NextCell carries out a directed issue of units to guarantors in connection with the completed rights issue
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. The Board of Directors of NextCell Pharma AB (publ) (“NextCell” or the “Company”) has today, based on the authorisation from the Annual General Meeting on 30 November 2023, resolved on a directed issue of 894,329 units to guarantors who provided guarantee commitments in the rights issue of units resolved upon by the Board of Directors on 24 April 2024 (the “Right Issue”), in accordance with guarantee agreements entered into (the “Remuneration Issue”). Each (1) unit consists of one (1) newly issued share and one (1) warrant of series TO2. The subscription price in the Remuneration Issue is SEK 1.50 per unit and payment is made by offsetting the guarantors’ claims on the Company.
Read moreRead more
2024-06-17
NextCell’s rights issue oversubscribed
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”) hereby announces the outcome of the Company’s rights issue of units, consisting of shares and warrants of series TO2, with preferential rights for the Company’s existing shareholders, which was announced through a press release on 24 April 2024 (the “Rights Issue”). The outcome of the Rights Issue shows that 34,747,218 units, corresponding to approximately 91.9 percent of the Rights Issue, were subscribed for with the support of unit rights. In addition, applications for subscription of 22,636,886 units without the support of unit rights have been submitted, corresponding to approximately 59.9 percent of the Rights Issue. Together, subscriptions of units with the support of unit rights and applications for subscription of units without the support of unit rights correspond to approximately 151.7 percent of the Rights Issue. The Rights Issue is therefore oversubscribed and NextCell will from the Rights Issue receive approximately SEK 40.1 million before deduction of issue costs.
Read moreRead more