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)
2025-03-13
Results from the Older Age Cohort in the ProTrans-Young Paediatric Study Expected in Aprilv
NextCell Pharma AB ("NextCell" or "the Company") announces that the last patient in the older age cohort (12–21 years) of the clinical Phase II study, ProTrans-Young, has now completed their 12-month follow-up. The collected data is currently being compiled, and an administrative subgroup analysis is planned to be presented at the IDF World Diabetes Congress in Bangkok from April 7–10.
Read moreRead more
2025-02-19
All Patients with Severe Virus-Induced Pneumonia Treated in the ProTrans V Study
NextCell Pharma AB ("NextCell") announced today that all patients in the clinical trial ProTrans V, where ProTrans is used for the treatment of severe virus-induced pneumonia, have been treated. The study is being conducted at Örebro University Hospital and includes a total of nine patients, with three patients in each dose group.  
Read moreRead more
2025-01-30
NextCell Pharma publish Interim Report 1 2024/2025
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 1 for the period September 1, 2024 – November 30, 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
2024-12-17
Long-term Effects with Repeated ProTrans Treatment After 6 Years
NextCell Pharma AB reports new results from the ProTrans-Repeat study, where type 1 diabetes patients have been followed for 5 years after receiving two doses of the stromal cell product ProTrans, in total 6 years after the first infusion. The results show that two out of three patients in the high-dose group increased their insulin production by 23% and 34% respectively.
Read moreRead more
2024-12-05
NextCell Pharma changes Certified Adviser to Redeye AB
NextCell Pharma has entered into an agreement with Redeye AB regarding the service as Certified Adviser. Redeye AB will take over as Certified Adviser on January 1, 2025.
Read moreRead more
2024-11-25
QVance’s Partnerships Driving Innovation in Advanced Therapies
NextCell Pharma AB*, parent company of QVance, proudly supports QVance’s newly announced partnership with Royale International. This collaboration, which combines Royale International’s global expertise in logistics with QVance’s innovative quality control solutions, strengthens the supply chain for cell and gene therapies across Europe.
Read moreRead more
2024-11-18
QVance Announces Partnership
NextCell Pharma AB* comments on its subsidiary QVance’s partnership with bioMérieux Sweden AB, which aims to strengthen quality control analytics for cell and gene therapy products in the Nordic region. The collaboration will enhance QVance’s capacity to provide microbiological testing for advanced therapies.
Read moreRead more
2024-11-08
QVance AB Publishes Article on Particulates in Cell and Gene Therapy Products in Collaboration with ISCT
NextCell Pharma AB* announces that its subsidiary, QVance AB, has published an article in collaboration with the International Society of Cell and Gene Therapy (ISCT). The article, authored by Dr. Lindsay Davies, CSO at NextCell and co-founder of QVance, was published in Cytotherapy and is based on a global survey examining knowledge on particulates in cell and gene therapy (CGT) products.
Read moreRead more