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)
2018-01-31
NextCell Pharma changes ticker to NXTCL
NextCell Pharma AB ("NextCell") announces that it will change its ticker on Aktietorget to NXTCL. Since its listing on Aktietorget (2017-07-13), NextCell has been traded using the ticker NEXTCL. Management has decided to change the ticker to NXTCL. The new abbreviation might also be used in general market communications and company branding. The new ticker will become effective as per 2018-02-07, the company name and ISIN-code (SE0009723125) will remain the same. This information is the information that NextCell Pharma AB is required to disclose under the EU Market Abuse Regulation.
NextCell Pharma AB ("NextCell") announces that it will change its ticker on Aktietorget to NXTCL. Since its listing on Aktietorget (2017-07-13), NextCell has been traded using the ticker NEXTCL. Management has decided to change the ticker to NXTCL. The new abbreviation might also be used in gener...
Read moreRead more
2018-01-24
First diabetes patient treated with ProTrans stem cells
NextCell Pharma AB ("NextCell") announces that the first patient with type 1 diabetes has now been treated with the company's drug candidate ProTrans. The clinical trial evaluates the safety and efficacy of ProTrans after treatment of patients 18-40 years old and who had type 1 diabetes for a maximum of two years. The clinical trial started on November 28th, 2017 and after clinical assessment and baseline data collection, the first patient has now been treated (first-in-human) with ProTrans stem cells. The first part of the study is a three-step dose escalation with three patients in each
NextCell Pharma AB ("NextCell") announces that the first patient with type 1 diabetes has now been treated with the company's drug candidate ProTrans. The clinical trial evaluates the safety and efficacy of ProTrans after treatment of patients 18-40 years old and who had type 1 diabetes for a max...
Read moreRead more
2017-11-29
NextCell Pharma initiates stem cell trial for type 1-diabetes with ProTrans
NextCell Pharma AB ("NextCell") announces that the initiation meeting for the clinical trial in which drug candidate ProTrans will be evaluated, was held on November 28th, 2017. The trial will investigate safety as well as evaluate the patient’s own insulin production 12 months after receiving ProTrans stem cell treatment. Patients with type 1-diabetes being 18-40 years who received their diagnosis no later than 2 years ago and still have some insulin production are candidates for participation in the trial. NextCell Pharma has reached a new level as a company. I would like to thank all the
NextCell Pharma AB ("NextCell") announces that the initiation meeting for the clinical trial in which drug candidate ProTrans will be evaluated, was held on November 28th, 2017. The trial will investigate safety as well as evaluate the patient’s own insulin production 12 months after receiving Pr...
Read moreRead more
2017-11-14
Today Nextcell Pharma publishes its annual report 2016-2017
NextCell Pharma AB (publ) hereby publishes the annual report for the financial year 2016/2017. The annual report is attached to this press release and can be downloaded from the company's website www.nextcellpharma.com
NextCell Pharma AB (publ) hereby publishes the annual report for the financial year 2016/2017. The annual report is attached to this press release and can be downloaded from the company's website www.nextcellpharma.com...
Read moreRead more
2017-10-31
NextCell Pharma updates on its situation in its fourth quarter report
NextCell Pharma AB ("NEXTCL", "NextCell") today releases its Q4 / year-end report (June 1st - August 31st  / September 1st - August 31st). This is the first quarterly report since the listing on Aktietorget. The company reports a loss of SEK -4,757,996 in its fourth quarter and a loss of SEK -13,245,206 for the entire financial year. The remaining cash at August 31st was approximately 16 MSEK. The perhaps most important event during the fourth quarter was the listing on Aktietorget on July 13th and the associated listing issue, which was subscribed to approximately 18 MSEK, corresponding to
NextCell Pharma AB ("NEXTCL", "NextCell") today releases its Q4 / year-end report (June 1st - August 31st  / September 1st - August 31st). This is the first quarterly report since the listing on Aktietorget. The company reports a loss of SEK -4,757,996 in its fourth quarter and a loss of SEK -13,...
Read moreRead more
2017-10-17
NextCell Pharma's stem cell study in Type 1 Diabetes gets green light from the Medical Products Agency
NextCell Pharma AB ("NextCell") today announces that the Swedish Medical Products Agency has granted permission to conduct the clinical trial investigating the drug candidate ProTrans. For more information regarding the clinical trial, please see press release from 15th of September. This information is the information that NextCell Pharma AB is required to disclose under the EU Market Abuse Regulation. The information was provided by the above contact person for publication on October 17th, 2017.
NextCell Pharma AB ("NextCell") today announces that the Swedish Medical Products Agency has granted permission to conduct the clinical trial investigating the drug candidate ProTrans. For more information regarding the clinical trial, please see press release from 15th of September. This inform...
Read moreRead more
2017-10-11
Family saving of stem cells at Underbara Barn held atStockholm International Fair and Congresses Centre,13-15 October, 2017
For the third consecutive year, Cellaviva will exhibit at the Underbara Barn Fair to meet and inform its (prospective) customers. The fair is targeted at future parents and those with young children. Representatives from the company will inform visitors about the family saving of stem cells from the umbilical cord. Cellaviva is Sweden's first and only biobank for family-saving of stem cells and is owned by the stem cell company NextCell Pharma AB (NEXTCL). The applications for stem cell therapy are rapidly growing in modern medicine. Cells from family members are preferred for the treatment
For the third consecutive year, Cellaviva will exhibit at the Underbara Barn Fair to meet and inform its (prospective) customers. The fair is targeted at future parents and those with young children. Representatives from the company will inform visitors about the family saving of stem cells from ...
Read moreRead more
2017-09-21
NextCell Pharma receives wholesale distribution authorisation
NextCell Pharma AB ("NextCell") today announces that the company has been granted license for wholesale of cell based investigational medicinal products. The company was inspected earlier this summer by the Swedish Medical Products Agency. The permission is required for NextCell to acquire, stock and distribute investigational drugs in the planned clinical trial of ProTrans™ for treatment of diabetes. CEO Mathias Svahn says “This license is a good next step towards the start of our first clinical trial with ProTrans™ for the treatment of patients with Type 1 diabetes”. About the clinical
NextCell Pharma AB ("NextCell") today announces that the company has been granted license for wholesale of cell based investigational medicinal products. The company was inspected earlier this summer by the Swedish Medical Products Agency. The permission is required for NextCell to acquire, stock...
Read moreRead more