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.

Download attachmentRead full press release on Cision (external link)
2019-07-31
Interim report 2018-09-01 - 2019-05-31
Third quarter report By "NextCell", “NXTCL” or "Company" is meant NextCell Pharma AB with organization number 556965-8361. “Spotlight" refers to the Spotlight Stock Market (previous AktieTorget). Amount in brackets refer to the corresponding period in the previous year. Note that the Company's fiscal year is September 1 - August 31. This English version is a translation of the Swedish version. The Swedish version is at all time to be seen as the leading document. Nine months (2018-09-01 until 2019-05-31) · Operating income amounted to SEK 1 410 055 (527 545). · Operating result
Third quarter report By "NextCell", “NXTCL” or "Company" is meant NextCell Pharma AB with organization number 556965-8361. “Spotlight" refers to the Spotlight Stock Market (previous AktieTorget). Amount in brackets refer to the corresponding period in the previous year. Note that the Company's f...
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2019-06-20
Final patient treated in the phase II part of the ProTrans-1 trial
NextCell Pharma AB (NextCell) today treated the last diabetic patient in the phase II part of the ProTrans-1 trial. This means that all patients included in the clinical study have been treated and are now subject to a 12-month follow-up period before efficacy and safety data will be available. The final patient has been treated in the randomized, placebo controlled ProTrans-1 phase II part trial. Efficacy and safety data will be collected through regular clinical assessments visits during a 12 month period. Last patient, last will be assessed in July 2020 and thereafter the code will be
NextCell Pharma AB (NextCell) today treated the last diabetic patient in the phase II part of the ProTrans-1 trial. This means that all patients included in the clinical study have been treated and are now subject to a 12-month follow-up period before efficacy and safety data will be available. T...
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2019-06-20
New collaboration and increased digital presence - Cellaviva is gearing for growth
NextCell Pharma AB ("NextCell") today announces that they, via its biobank Cellaviva, have entered into a partnership with Bonzun Health Information AB ("Bonzun"), who are providing the first global health app for pregnant women. Bonzun has launched the first virtual midwife for pregnant women which can be downloaded in Appstores under the name Bonzun Pregnant. The app is currently available in 79 countries worldwide under the name Bonzun and in Sweden under the name Min Graviditet. The collaboration has been entered into with the common goal of strengthening the work of sharing knowledge
NextCell Pharma AB ("NextCell") today announces that they, via its biobank Cellaviva, have entered into a partnership with Bonzun Health Information AB ("Bonzun"), who are providing the first global health app for pregnant women. Bonzun has launched the first virtual midwife for pregnant women wh...
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2019-06-19
NextCell has treated the first patient in the ProTrans-Repeat trial
NextCell Pharma AB (NextCell) announces that earlier today the first patient was treated as part of the ProTrans-Repeat trial, which is NextCell’s second clinical trial. ProTrans-Repeat is a Phase IIa clinical trial which includes patients receiving active treatment with ProTrans and who have previously been treated in the ProTrans-1 study's dose escalation phase. This means that the participants receive their second treatment with ProTrans, just over a year after the first. The goal of the ProTrans-Repeat trial is to test whether repeated treatment can increase or maintain the effect of
NextCell Pharma AB (NextCell) announces that earlier today the first patient was treated as part of the ProTrans-Repeat trial, which is NextCell’s second clinical trial. ProTrans-Repeat is a Phase IIa clinical trial which includes patients receiving active treatment with ProTrans and who have pre...
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2019-06-11
Anders Essen-Möller subscribes to his entire stakes in NextCell Pharmas right issue
The two largest owners of NextCell Pharma AB (“NextCell” or “The Company”) Anders Essen-Möller and Diamyd Medical AB, fully subscribe for their respective shares in NextCells ongoing rights issue. This means that both parties consolidate their ownership interests and that Essen-Möllers ownership in NextCell after the investments increases from approximately SEK 3.6 million to 6.0 million. Regarding the ongoing rights issue in NextCell, the principal owner Anders Essen-Möller, also the chairman of the company, has chosen to fully utilize its allotted subscription rights, which means that he
The two largest owners of NextCell Pharma AB (“NextCell” or “The Company”) Anders Essen-Möller and Diamyd Medical AB, fully subscribe for their respective shares in NextCells ongoing rights issue. This means that both parties consolidate their ownership interests and that Essen-Möllers ownership ...
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2019-06-05
Selected to participate in the EIT Health Start.Smart.Global (SSG) programme.
NextCell Pharma AB (publ) ("NextCell") has been chosen as one of a select group of companies to participate in the EIT Health Start.Smart.Global (SSG) programme. The programme focusses on helping European life science SMEs successful entries into Japan and South Korea. EIT Health is a Knowledge and Innovation Community established by the European Institute for Innovation & Technology (EIT) (https://eit.europa.eu/), an independent EU body set up to promote innovation and entrepreneurship across Europe. The EIT Health Start.Smart.Global (SSG) programme, helps European life science SMEs
NextCell Pharma AB (publ) ("NextCell") has been chosen as one of a select group of companies to participate in the EIT Health Start.Smart.Global (SSG) programme. The programme focusses on helping European life science SMEs successful entries into Japan and South Korea. EIT Health is a Knowledge a...
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2019-05-17
NextCell now has two parallel running clinical trials, ProTrans-1 and ProTrans-Repeat which was initiated today
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NextCell Pharma AB (NextCell) announces that the initiation meeting for ProTrans-Repeat was held today at Karolinska University Hospital in Huddinge. ProTrans-Repeat is a completely independent trial and has no effect on the ProTrans-1 study. NextCell now has two ongoing clinical trials that run ...
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2019-05-17
Rectification: Six out of nine patients in the first part of the phase I/II trial, ProTrans-1 have completed treatment
NextCell Pharma AB (NextCell) announces that six out of the nine patients included in the dose escalation part of ProTrans-1, the trial with the drug candidate ProTrans, now have completed treatment and left the study. Earlier this week, the last of the three patients in the so-called medium-dose-cohort visited for their 12-month follow-up, the final part of the trial, which means that all three now have completed their part of the trial. In early March, the three patients in the low-dose cohort had already completed the trial. This means that six out of nine patients in the phase I part
NextCell Pharma AB (NextCell) announces that six out of the nine patients included in the dose escalation part of ProTrans-1, the trial with the drug candidate ProTrans, now have completed treatment and left the study. Earlier this week, the last of the three patients in the so-called medium-dose...
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