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

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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.

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2018-07-31
NextCell Pharma publishes quarterly report three 2017/2018
NextCell Pharma AB (”NXTCL”, “NextCell”) today, released its third quarter report 2017/2018 (September 2017 – May 2018). Nine Months (2017-09-01 until 2018-05-31)  · Net sales amounted to SEK 527 545 (318 438). · Operating result amounted to SEK -10 610 012 (-8 477 749).                      · Result per share* amounted to SEK -1,25 (-2,89). · Cash and bank amounted to SEK 5 929 492 (6 558 898). · Solidity amounted to 83.8 (70.4)%. · Net sales amounted to SEK 136 341 (197 846). · Operating result amounted to SEK -3 085 756 (-3 614 243).                        ·
NextCell Pharma AB (”NXTCL”, “NextCell”) today, released its third quarter report 2017/2018 (September 2017 – May 2018). Nine Months (2017-09-01 until 2018-05-31)  · Net sales amounted to SEK 527 545 (318 438). · Operating result amounted to SEK -10 610 012 (-8 477 749).                     ...
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2018-07-30
NextCell Pharma introduces stem cell service for adults
Stem cell company NextCell Pharma AB (“NXTCL”) announces that it is preparing to launch a service for saving adipose (fat) tissue derived stem cells during the first half of 2019. The service allows adults to save their own stem cells for future use. The stem cells are collected by liposuction, purified, processed and frozen in liquid nitrogen. The effort is made in the light of the rapid development of techniques for differentiation of induced pluripotent stem cells, iPS cells, as well as regeneration of tissues for treatment in a variety of indications. NXTCL is first in Sweden to offer
Stem cell company NextCell Pharma AB (“NXTCL”) announces that it is preparing to launch a service for saving adipose (fat) tissue derived stem cells during the first half of 2019. The service allows adults to save their own stem cells for future use. The stem cells are collected by liposuction, p...
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2018-07-18
NextCell celebrates its first-year anniversary as a listed company
The potential market for stem cell therapies is immense and development is at record speed. On July 13, 2017, stem cell company NextCell Pharma AB ("NextCell") was listed on Spotlight Stock Market (formerly AktieTorget). In his own words, CEO Mathias Svahn reflects on the company’s first year as a listed company and sends a reminder regarding the company's upcoming option redemption period. "We have promised a lot - we delivered even more. In the spring of 2017, we turned to you, our shareholders and asked for your investment to enable us to develop an advanced stem cell therapy which is
The potential market for stem cell therapies is immense and development is at record speed. On July 13, 2017, stem cell company NextCell Pharma AB ("NextCell") was listed on Spotlight Stock Market (formerly AktieTorget). In his own words, CEO Mathias Svahn reflects on the company’s first year as ...
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2018-07-09
Publication of scientific article regarding the clinical trial with ProTrans
The stem cell company NextCell Pharma AB ("NXTCL") today announced, that a scientific article describing the ongoing clinical trial with ProTrans has been published in Clinical Trials in Degenerative Diseases (CTDD), a peer reviewed journal encompassing clinical trials, research, therapeutics and education within the field of degenerative diseases. The scientific article was written by Per-Ola Carlsson, principal investigator of the ongoing clinical study with ProTrans and Mathias Svahn, CEO of NXTCL The title of the article is: “Wharton’s jelly derived allogeneic mesenchymal stromal cells
The stem cell company NextCell Pharma AB ("NXTCL") today announced, that a scientific article describing the ongoing clinical trial with ProTrans has been published in Clinical Trials in Degenerative Diseases (CTDD), a peer reviewed journal encompassing clinical trials, research, therapeutics and...
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2018-07-03
NextCell applies for prediction methodology patent
The stem cell company NextCell Pharma AB ("NXTCL") has submitted another patent application. This time regarding a method for predicting if a specific patient is susceptible to treatment with the drug candidate ProTrans. Since the beginning of 2017, NXTCL has performed preclinical experiments in parallel with the ongoing clinical trial with ProTrans, for the treatment of diabetes. The purpose of these experiments was in part to predict, in advance, whether ProTrans treatment should be beneficial for a particular patient. The patent application describes how to isolate the patient's immune
The stem cell company NextCell Pharma AB ("NXTCL") has submitted another patent application. This time regarding a method for predicting if a specific patient is susceptible to treatment with the drug candidate ProTrans. Since the beginning of 2017, NXTCL has performed preclinical experiments in ...
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2018-06-29
The Data and Safety Monitoring Board approves the usage of high-dose ProTrans in the ongoing clinical trial
Stem cell company NextCell Pharma AB ("NXTCL") announces today that the Data and Safety Monitoring Board for the clinical trial using ProTrans has given its approval for the principal investigator professor Per-Ola Carlsson and NextCell to proceed and treat 3 patients in the high-dose cohort. The treatment of all three patients in the medium-dose cohort with ProTrans has been assessed as safe using a one-month follow-up period. Now NXTCL is now able to recruit patients for the last dose cohort, which is the high-dose cohort. The recruitment of the last dose cohort is expected to take one
Stem cell company NextCell Pharma AB ("NXTCL") announces today that the Data and Safety Monitoring Board for the clinical trial using ProTrans has given its approval for the principal investigator professor Per-Ola Carlsson and NextCell to proceed and treat 3 patients in the high-dose cohort. The...
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2018-06-28
Extended tissue establishment authorization
The stem cell company NextCell Pharma AB ("NXTCL") was inspected on 7th May 2018 by the Health and Care Inspectorate (IVO), which is the supervisor of tissue establishments. NXTCL has today received the inspection report that authorizes the business to continue without any changes being required. NXTCL acquired the tissue establishment authorization in 2014-11-19. The permit is reviewed every other year in connection with inspection. The operations were inspected 2016-01-20 and now by 2018-05-07, again with a positive outcome. Tissue establishment is an establishment where physical or
The stem cell company NextCell Pharma AB ("NXTCL") was inspected on 7th May 2018 by the Health and Care Inspectorate (IVO), which is the supervisor of tissue establishments. NXTCL has today received the inspection report that authorizes the business to continue without any changes being required....
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2018-05-18
Six patients now treated with NextCells ProTrans stem cells
NextCell Pharma AB ("NXTCL") announces that an additional three patients have been treated with ProTrans in the ongoing clinical phase I/II trial. In total 6 patients with type 1 diabetes in the low- and medium-dose-cohort have now undergone treatment. The trial performed with NXTCL's drug candidate ProTrans, is divided into two parts, the first part being a dose-escalation phase with 3 + 3 + 3 patients being treated with either a; low, medium or high dose of ProTrans. Now all patients in the low-dose-cohort and the medium-dose-cohort have been treated. After the 1-month follow-up of the
NextCell Pharma AB ("NXTCL") announces that an additional three patients have been treated with ProTrans in the ongoing clinical phase I/II trial. In total 6 patients with type 1 diabetes in the low- and medium-dose-cohort have now undergone treatment. The trial performed with NXTCL's drug candid...
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