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)
2019-11-07
Correction: Notice to attend the Annual General Meeting
NextCell Pharma AB ("NextCell") announces that a notice of the Annual General Meeting for the 2018-2019 financial year has been published. Compared to the press release published this morning, corrections have been made regarding the Market Abuse Regulation label. The information is not subject to the Market Abuse Regulation. The annual general meeting will be held on December 5, 2019 at 10.00 at Novum, Hälsovägen 7, Huddinge. The notice has been published in Svenska Dagbladet and Post and Inrikes Tidningar as well as on the company's website, www.nextcellpharma.com. The Annual Report and
NextCell Pharma AB ("NextCell") announces that a notice of the Annual General Meeting for the 2018-2019 financial year has been published. Compared to the press release published this morning, corrections have been made regarding the Market Abuse Regulation label. The information is not subject t...
Read moreRead more
2019-11-07
Notice to attend the Annual General Meeting
NextCell Pharma AB ("NextCell") announces that a notice of the Annual General Meeting for the 2018-2019 financial year has been published. The annual general meeting will be held on December 5, 2019 at 10.00 at Novum, Hälsovägen 7, Huddinge. The notice has been published in Svenska Dagbladet and Post and Inrikes Tidningar as well as on the company's website, www.nextcellpharma.com. The Annual Report and Audit Report will be available three weeks before the Meeting, November 14, on the Company's website, www.nextcellpharma.com. This information is the information that NextCell Pharma AB
NextCell Pharma AB ("NextCell") announces that a notice of the Annual General Meeting for the 2018-2019 financial year has been published. The annual general meeting will be held on December 5, 2019 at 10.00 at Novum, Hälsovägen 7, Huddinge. The notice has been published in Svenska Dagbladet and ...
Read moreRead more
2019-10-31
Year-end report 2018-09-01 - 2019-08-31
Nextcell Pharma AB ("NXTCL") today announces the year-end report for the 2018/2019 fiscal year (2018-08-31 2019-08-31) Twelve months (2018-09-01 until 2019-08-31) · Operating income amounted to SEK 1 964 132 (655 413). · Operating result amounted to SEK -21 450 784 (-14 032 294).                · Earnings per share* amounted to SEK -1.36 (-0.61). · Cash and bank amounted to SEK 20 128 185 (3 115 876). · Solidity** amounted to 85.9 (59.2) %. Fourth quarter (2019-06-01 until 2019-08-31) · Operating income amounted to SEK 551 708 (127 868). · Operating result
Nextcell Pharma AB ("NXTCL") today announces the year-end report for the 2018/2019 fiscal year (2018-08-31 2019-08-31) Twelve months (2018-09-01 until 2019-08-31) · Operating income amounted to SEK 1 964 132 (655 413). · Operating result amounted to SEK -21 450 784 (-14 032 294).            ...
Read moreRead more
2019-10-25
NextCell invests in the Danish Cellaviva operations with a new Copenhagen office
NextCell Pharma AB ("NextCell") today announces they are investing for growth in Cellaviva's Danish operations with the opening of a new Copenhagen office. In October, Cellaviva's new office was opened in Copenhagen, located in Kløvebyen. The Copenhagen office is primarily intended to be a hub for the Danish Cellaviva business with the opportunity to host customers, hold training sessions etc. The purpose is also to enable increased exposure and presence for NextCell in the Öresund region. [image]      [image]
NextCell Pharma AB ("NextCell") today announces they are investing for growth in Cellaviva's Danish operations with the opening of a new Copenhagen office. In October, Cellaviva's new office was opened in Copenhagen, located in Kløvebyen. The Copenhagen office is primarily intended to be a hub fo...
Read moreRead more
2019-10-01
All patients in ProTrans-Repeat are now treated
NextCell Pharma AB ("NextCell") announces that another significant milestone has been reached when the last patient, as part of the ProTrans-Repeat active treatment group, today has received their treatment. This implies that all treatments, related to the two ongoing ProTrans studies, have been completed. NextCell is conducting two parallel clinical trials with the drug candidate ProTrans, with the aim to treat diabetes type-1. ProTrans-Repeat, which was initiated in May 2019, is a continuation trial of ProTrans-1 dose escalation part with the aim of maximizing data collection on repeated
NextCell Pharma AB ("NextCell") announces that another significant milestone has been reached when the last patient, as part of the ProTrans-Repeat active treatment group, today has received their treatment. This implies that all treatments, related to the two ongoing ProTrans studies, have been ...
Read moreRead more
2019-09-24
Last patient, last visit completed in the dose escalation part
NextCell Pharma AB (NextCell) is today announcing that the last patient in the dose escalation part of the clinical trial ProTrans-1 for diabetes is completed. The last patient was today at the last visit and has now left the trial. ProTrans-1 is a two-part phase I / II clinical trial where the phase I part evaluates safety for three doses. All nine patients have now been followed up for 12 months and have left the study. As previously communicated, all 15 patients in the phase II part of ProTrans-1 have been treated and will be followed for 12 months. The second part is randomized,
NextCell Pharma AB (NextCell) is today announcing that the last patient in the dose escalation part of the clinical trial ProTrans-1 for diabetes is completed. The last patient was today at the last visit and has now left the trial. ProTrans-1 is a two-part phase I / II clinical trial where the p...
Read moreRead more
2019-09-12
Update on the ongoing clinical trials
NextCell Pharma AB (NextCell) is today providing a status update regarding its two ongoing clinical trials, presented at the Nordic Life Science days in Malmö. All patients in ProTrans-1 were treated by June 2019 and 8 out of 9 patients in the dose escalation part have already left the trial after 12 months follow-up. The ProTrans-Repeat has included 5 out of 18 patients. NextCell is conducting two parallel clinical trials with the drug candidate ProTrans, with the aim to treat type-1 diabetes. A single dose of ProTrans is given and the patients own ability to produce insulin is compared
NextCell Pharma AB (NextCell) is today providing a status update regarding its two ongoing clinical trials, presented at the Nordic Life Science days in Malmö. All patients in ProTrans-1 were treated by June 2019 and 8 out of 9 patients in the dose escalation part have already left the trial afte...
Read moreRead more
2019-08-16
NextCell Pharma files another patent application
NextCell Pharma AB ("NextCell") today announces that they have filed a new patent application to the Swedish Patent and Registration Office. The patent relates to the Company's proprietary selection algorithm, now with extended and tailored analyses for diseases and conditions affecting the central nervous system. The application was submitted to the Swedish Patent and Registration Agency on August 15 and is formulated to cover the general production of all types of mesenchymal stem cell products derived from multiple donors and cells selected by the selection algorithm. Furthermore, the
NextCell Pharma AB ("NextCell") today announces that they have filed a new patent application to the Swedish Patent and Registration Office. The patent relates to the Company's proprietary selection algorithm, now with extended and tailored analyses for diseases and conditions affecting the centr...
Read moreRead more