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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2018-08-23
NextCell's largest shareholder Diamyd Medical exercise all of its warrants
Stem cell company NextCell Pharma AB ("NXTCL") announces today, that its largest shareholder, Diamyd Medical AB, will exercise all its 296 800 series TO1 warrants. Diamyd will exercise the warrants during the subscription period which runs during the period 23rd August – 13th September 2018. This represents an investment total of SEK 1 484 000, corresponding to approximately 10 % of the outstanding warrants. The diabetes Company Diamyd Medical is one of the main owners of NextCell Pharma, with a shareholding of approximately 14 %. In addition to its current shares, Diamyd Medical also has
Stem cell company NextCell Pharma AB ("NXTCL") announces today, that its largest shareholder, Diamyd Medical AB, will exercise all its 296 800 series TO1 warrants. Diamyd will exercise the warrants during the subscription period which runs during the period 23rd August – 13th September 2018. This...
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2018-08-23
The subscription period of the series TO 1 warrants starts today
Stem cell company NextCell Pharma AB ("NXTCL") announces that today, 23rd of August 2018, marks the start of the subscription period of the series of TO 1 series warrants which were issued as part of the company's issue of units during the spring of 2017. The subscription period will end on the 13th of September 2018. Holders of the series TO 1 warrants are entitled to subscribe for a new share for each warrant at a price of SEK 5.00 per share. If all of the series TO 1 warrants are exercised, 2 860 940 new shares will be issued and NXTCL is receives approximately MSEK 14.3 before issue costs.
Stem cell company NextCell Pharma AB ("NXTCL") announces that today, 23rd of August 2018, marks the start of the subscription period of the series of TO 1 series warrants which were issued as part of the company's issue of units during the spring of 2017. The subscription period will end on the 1...
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2018-08-17
NextCell’s partner PBKM exercises its TO 1 warrants
Stem cell company NextCell Pharma AB ("NXTCL") announces today that its shareholder and partner Polski Bank Komorek Macierzystych S.A. ("PBKM") is exercising all of its 320,000 warrants. This represents an investment of MSEK 1.6, corresponding to approximately 11 % of the outstanding series TO 1 warrants. The subscription period of the series TO 1 warrants runs from 23rd of August – 13th of September 2018. PBKM is one of Europe's leading players in the field of stem cells and is also contracted for the manufacturing of NXTCL's drug candidate ProTrans. PBKM is thus an important partner of
Stem cell company NextCell Pharma AB ("NXTCL") announces today that its shareholder and partner Polski Bank Komorek Macierzystych S.A. ("PBKM") is exercising all of its 320,000 warrants. This represents an investment of MSEK 1.6, corresponding to approximately 11 % of the outstanding series TO 1 ...
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2018-08-13
An additional batch of ProTrans is released prior to use in NextCell Pharma’s ongoing clinical trial.
Stem cell company NextCell Pharma AB ("NextCell") hereby announces that it has received another batch of ProTrans for clinical use. ProTrans is manufactured according to GMP (Good Manufacturing Practices) and the stem cells are selected with the company's selection algorithm to ensure quality. The selection is carried out by NextCell and the large-scale production is then produced by supplier and shareholder Polski Bank Komorek Macierzystych S.A. ("PBKM"). The delivery is intended for use in the second part of the company's ongoing Phase I/II trial with ProTrans, which includes a total of 15
Stem cell company NextCell Pharma AB ("NextCell") hereby announces that it has received another batch of ProTrans for clinical use. ProTrans is manufactured according to GMP (Good Manufacturing Practices) and the stem cells are selected with the company's selection algorithm to ensure quality. Th...
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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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