Broader health benefits of ProTrans in treatment of type 1 diabetes

September 5, 2024

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.

A Single Dose of ProTrans Slows Disease Progression for More Than 5 Years. Patients from the Phase II trial have been monitored for over 5 years following a single dose of ProTrans. The long-term data that was presented in a press release 2024-05-28 shows that ProTrans treatment significantly slows the progression of T1D. This was described in detail at ISCT, using a non-linear regression analysis of the percentage loss of endogenous insulin production over time. The slopes of placebo-treated individuals were significantly steeper than those of ProTrans-treated individuals, indicating statistically significant differences in slowing disease progression year to year in the latter group (p<0.05-0.01).

ProTrans Treatment Supports Long-Term Health Benefits in T1D Patients. In addition to preserving insulin production, new data was presented where ProTrans also supported broader health benefits in patients over a multi-year follow-up period. Key findings include:

  • Body mass index (BMI) increased significantly in placebo-treated individuals, while BMI was maintained in ProTrans-treated patients after 2 years (p<0.05-0.01).
  • ProTrans-treated patients also exhibited a consistent trend of lower diastolic and systolic blood pressure, with significant differences emerging after 4-4.5 years compared to placebo-treated individuals (p<0.05).

The findings reinforce ProTrans as a promising cell therapy for T1D, capable of slowing disease progression and supporting broader metabolic health benefits in treated individuals.

NextCell Pharma also presented data on its strategy for delivering an off-the-shelf therapeutic that is accessible for patients irrespective of their geographical location. Cold chain management, standardised handling of the product and a long-term storage and stability of the product are a few of the unique features of ProTrans and how it has been developed with a commercial mindset.

For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 55 95
E-mail: info@nextcellpharma.com
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, CEO Cellaviva AB
Tel: +46 8 735 20 10
E-mail: info@cellaviva.se
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 in Phase II trials with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to obtain market approval of ProTrans via a phase III trial. In addition to type 1 diabetes, ProTrans is used in two clinical trials for COVID-19, in Örebro and in Montreal, Canada. Furthermore, NextCell owns 8.5% in FamicordTX, a CAR-T start-up in oncology, and 100% of Cellaviva AB, Scandinavia’s largest private stem cell bank licensed by the Swedish Health Authority (IVO) to preserve and store stem cells from umbilical cord blood and umbilical cord tissue for family use.

Download attachmentRead full press release on Cision (external link)
2021-05-21
Recruitment start for the ProTrans study for treatment of COVID-19
NextCell Pharma AB (“NextCell”) announces today that the Swedish COVID-19 stuy has been initiated and is now ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of needing ventilatory support. ProTrans is given as a peripheralinfusion. With the aim of reducing hyper-inflammation within the lungs. The goal of the treatment is to shorten hospital stay and time for rehabilitation and save lifes. The study will be performed at the University Hospital in Örebro in collaboration with the
NextCell Pharma AB (“NextCell”) announces today that the Swedish COVID-19 stuy has been initiated and is now ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of needing ventilatory suppo...
Read moreRead more
2021-04-29
NextCell Pharma publishes Interim Report 2 2020/2021
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period September 1, 2020 - February 28, 2021 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. Second quarter (2020-12-01 until 2021-02-28) · Operating income amounted to SEK 1 007 846 (1 364 645). · Operating result amounted to SEK -8 148 299 (-4 228 449). · Earnings
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period September 1, 2020 - February 28, 2021 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 ...
Read moreRead more
2021-04-27
Presentation of the pediatric diabetes study tomorrow Wednesday
NextCell Pharma AB (“NextCell”) has invited Professor Per-Ola Carlsson to present study design and rational for the pediatric study, ProTrans-Young. The trial, recently approved, is a phase I / II study with a total of 66 patients with newly diagnosed type-1 diabetes. The presentation will be broadcasted tomorrow, Wednesday April 28, at 14:00. Afterwards, there is an opportunity to ask questions to Professor Carlsson and NextCell's CEO and CSO. https://youtu.be/kE4POLMlXWA.
NextCell Pharma AB (“NextCell”) has invited Professor Per-Ola Carlsson to present study design and rational for the pediatric study, ProTrans-Young. The trial, recently approved, is a phase I / II study with a total of 66 patients with newly diagnosed type-1 diabetes. The presentation will be br...
Read moreRead more
2021-04-14
Pediatric diabetes study with stem cells approved
NextCell Pharma AB ("NextCell") announces today that Uppsala University Hospital and the principal investigator, Professor Per-Ola Carlsson, have been granted approval from the Medical Products Agency and the Swedish Ethical Review Authority to conduct a clinical drug trial with ProTrans™ to treat children and adolescents with type-1 diabetes. The study is a phase I / II study with a total of 66 patients. The first six patients treated will be evaluated for safety. The first six patients, three adolescents (12-18 years) and three children (7-11 years), will be treated and assessed for safety.
NextCell Pharma AB ("NextCell") announces today that Uppsala University Hospital and the principal investigator, Professor Per-Ola Carlsson, have been granted approval from the Medical Products Agency and the Swedish Ethical Review Authority to conduct a clinical drug trial with ProTrans™ to trea...
Read moreRead more
2021-03-31
NextCell welcomes Consensus Sverige Selectas as a shareholder
The Board of Directors of NextCell Pharma AB (”NextCell or the ”Company”) has today, based on the authorization granted by the Annual General Meeting held on 24 November 2020, resolved on a directed issue of 666,666 new shares (the “Share Issue”) to Consensus Sverige Select (”Consensus”). The subscription price in the share issue amounts to SEK 15 per new share and the Company receives approximately SEK 10 million in issue proceeds. The Board of Directors of NextCell has today, based on the authorization granted by the Annual General Meeting held on 24 November 2020, resolved on the Share
The Board of Directors of NextCell Pharma AB (”NextCell or the ”Company”) has today, based on the authorization granted by the Annual General Meeting held on 24 November 2020, resolved on a directed issue of 666,666 new shares (the “Share Issue”) to Consensus Sverige Select (”Consensus”). The sub...
Read moreRead more
2021-03-02
The stem cell company NextCell invests in own production facility
The stem cell company NextCell Pharma AB (“NextCell” or “the Company”) announces today that they have entered into an agreement with the property manager Hemsö and the clean room supplier QleanAir, to build a full-scale production facility. This new production facility will be directly connected to the Company's existing office and clean room in the Novum building, next to Karolinska University Hospital in Huddinge. The construction will take place later this spring and the premises are expected to be completed during the third quarter of 2021. The significant upcomming medical need for
The stem cell company NextCell Pharma AB (“NextCell” or “the Company”) announces today that they have entered into an agreement with the property manager Hemsö and the clean room supplier QleanAir, to build a full-scale production facility. This new production facility will be directly connected ...
Read moreRead more
2021-02-02
Canadian Trial for ProTrans in COVID-19
NextCell Pharma AB (“NextCell”) today announces that Health Canada and the McGill University Health Centre Research Ethics Board have authorized the clinical trial entitled “Treatment of Respiratory Complications Associated with COVID-19 Infection Using Wharton’s Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans™): a Randomized Phase II Controlled Clinical Trial”. The sponsor for this trial is the Research Institute of the McGill University Health Centre. The trial will enrol 48 patients with severe pneumonia associated with confirmed COVID-19 (SARS-CoV-2) infection,
NextCell Pharma AB (“NextCell”) today announces that Health Canada and the McGill University Health Centre Research Ethics Board have authorized the clinical trial entitled “Treatment of Respiratory Complications Associated with COVID-19 Infection Using Wharton’s Jelly (WJ)-Umbilical Cord (UC) Me...
Read moreRead more
2021-01-29
NextCell Pharma publishes Interim Report 1 2020/2021
NextCell Pharma AB (publ) (NXTCL) publishes its Interim Report 1 for the period September 1, 2020 - November 30, 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. First quarter (2020-09-01 until 2020-11-30) · Operating income amounted to SEK 1 148 187 (1 222 087) · Operating result amounted to SEK -17 680 697 (-17 997 787).. · Earnings per share
NextCell Pharma AB (publ) (NXTCL) publishes its Interim Report 1 for the period September 1, 2020 - November 30, 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...
Read moreRead more