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)
2019-01-31
Iterim report quarter 1
First quarter (2018-09-01 till 2018-11-30) · Net sales amounted to SEK 73,745 (158,354). Apart from the accrual effect, sales increased by 7 %. · Operating result amounted to SEK -5,440,809 (-3,210,815).                         · Earnings per share* amounted to SEK -0.51 (-0.38). · Cash and bank amounted to SEK 10,437,405 (13,365,659). · Solidity** amounted to 87 (59) %. **Result per share: operating results divided by the average number of shares. Average number of shares for the first quarter of 2018/2019: 10,693,960 shares (8,505,425). Number of shares in NextCell as
First quarter (2018-09-01 till 2018-11-30) · Net sales amounted to SEK 73,745 (158,354). Apart from the accrual effect, sales increased by 7 %. · Operating result amounted to SEK -5,440,809 (-3,210,815).                         · Earnings per share* amounted to SEK -0.51 (-0.38). · Cash ...
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2019-01-30
Patients treated with ProTrans in phase II of the clinical trial
NextCell Pharma AB ("NextCell") hereby announces that they today have reached a significant milestone as they have now initiated the second part of the ProTrans-1 clinical trial. In addition to safety, clinical efficacy is evaluated, e.g. whether the patient's own insulin production improves 12 months after treatment with ProTrans compared to placebo. The phase-II part is randomized, double-blind, placebo-controlled which means that neither the patient nor the doctor knows what treatment the patient is receiving. So far, two patients have undergone treatment. In total, 15 patients will be
NextCell Pharma AB ("NextCell") hereby announces that they today have reached a significant milestone as they have now initiated the second part of the ProTrans-1 clinical trial. In addition to safety, clinical efficacy is evaluated, e.g. whether the patient's own insulin production improves 12 m...
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2018-12-05
NextCell strengthens the organization for continued growth
NextCell Pharma AB ("NextCell") hereby announces that the Board has decided to appoint Sofia Fredrikson to CFO in the company. Sofia Fredrikson will take office starting today. Former CFO, Leo Groenewegen, will continue to work for the company in the newly created role of Business Development Manager. Both Sofia Fredrikson and Leo Groenewegen will be part of NextCell's management team. Sofia Fredrikson, born 1983, has been employed by NextCell since November 2018. The Board has now decided to appoint Fredrikson as CFO for the company. Sofia Fredrikson has worked as an authorized accountant
NextCell Pharma AB ("NextCell") hereby announces that the Board has decided to appoint Sofia Fredrikson to CFO in the company. Sofia Fredrikson will take office starting today. Former CFO, Leo Groenewegen, will continue to work for the company in the newly created role of Business Development Man...
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2018-11-28
NextCell CEO invited speaker at Karolinska Institutet Conference
NextCell Pharma AB ("NXTCL") announces that its CEO, Mathias Svahn PhD has been invited to speak at the Karolinska Institutet conference “From tissue to motion” - a 10-year anniversary. The conference brings together different research groups within the field of regenerative medicine who will meet with entrepreneurs and life science companies for two days. The scope is to cover the very latest progress of the research in the multidisciplinary fields of regenerative medicine, motion and health.
NextCell Pharma AB ("NXTCL") announces that its CEO, Mathias Svahn PhD has been invited to speak at the Karolinska Institutet conference “From tissue to motion” - a 10-year anniversary. The conference brings together different research groups within the field of regenerative medicine who will mee...
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2018-11-16
ProTrans trial is approved for high dose treatment in the phase II part
The stem cell company NextCell Pharma AB ("NXTCL") today announced that the Swedish Medical Product Agency has approved the amendment for treatment of patients in the ProTrans-1 trial with high dose of ProTrans in the randomized placebo-controlled part. The ProTrans clinical trial is divided into a dose-scale part where 9 patients were treated with ProTrans during 2018. On October 25th, the Data Safety and Monitoring Board recommended the start of the second part of the trial with the dose that the study team found most appropriate. The safety of ProTrans seem well tolerated, NXTCL
The stem cell company NextCell Pharma AB ("NXTCL") today announced that the Swedish Medical Product Agency has approved the amendment for treatment of patients in the ProTrans-1 trial with high dose of ProTrans in the randomized placebo-controlled part. The ProTrans clinical trial is divided into...
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2018-11-14
NextCell Pharma's clinical trial on the TV3 Diabetes gala
Stem cell company NextCell Pharma AB ("NXTCL") announces that the ongoing clinical trial with ProTrans for the treatment of type 1 diabetes, tonight will be highlighted on the Diabetes Gala. A shorter clip will be shown on the gala and a longer version will be available on ViaPlay, Viafree and on the NXTCL website. The broadcast strats at 20:00.
Stem cell company NextCell Pharma AB ("NXTCL") announces that the ongoing clinical trial with ProTrans for the treatment of type 1 diabetes, tonight will be highlighted on the Diabetes Gala. A shorter clip will be shown on the gala and a longer version will be available on ViaPlay, Viafree and on...
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2018-11-12
Earlier announced directed share issue to Nordic Tech House AB registered at the Swedish Companies Registrations Office
NextCell Pharma AB ("NextCell") hereby announces that the directed share issue to Nordic Tech House AB (”NTH”) has been registered at the Swedish Companies Registrations Office (Bolagsverket). The newly issued shares are under lock-up. In total, 260 100 shares have been issued at a subscription price of SEK 5.767 per share, equivalent to 2.3 percent of votes and capital in NXTCL. The shares will be settled retrospectively. After the registration at the Swedish Companies Registrations Office, the total amount of shares in NXTCL are 11 486 456 and the share capital is SEK 2 354 723,48. NTH has
NextCell Pharma AB ("NextCell") hereby announces that the directed share issue to Nordic Tech House AB (”NTH”) has been registered at the Swedish Companies Registrations Office (Bolagsverket). The newly issued shares are under lock-up. In total, 260 100 shares have been issued at a subscription p...
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2018-11-09
Publication of annual report 2017/2018
NextCell Pharma AB hereby, on November 9th, 2018, publishes the annual report for the fiscal year 2017/2018. The annual report is available on the company’s website (www.nextcellpharma.com) and Spotlight Stock Market’s website (www.spotlightstockmarket.com).
NextCell Pharma AB hereby, on November 9th, 2018, publishes the annual report for the fiscal year 2017/2018. The annual report is available on the company’s website (www.nextcellpharma.com) and Spotlight Stock Market’s website (www.spotlightstockmarket.com)....
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