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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2018-11-05
Application for clinical trial submitted to the Medical Products Agency, ProTrans-2.
NextCell Pharma AB ("NXTCL") today announced that a new application to conduct a clinical trial with ProTrans has been submitted to the Swedish Medical Products Agency. The purpose of the study is to evaluate repeated treatment with ProTrans, including patients with type 1 diabetes who participated in the dose escalating part of the original NXTCL trial. The ongoing clinical trial called ProTrans-1, was initiated with a dose escalation phase for 9 patients all followed for 12 months. After their last visit in the study, patients will be asked if they want to participate in a new study where
NextCell Pharma AB ("NXTCL") today announced that a new application to conduct a clinical trial with ProTrans has been submitted to the Swedish Medical Products Agency. The purpose of the study is to evaluate repeated treatment with ProTrans, including patients with type 1 diabetes who participat...
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2018-11-02
Update regarding targeted new issue to Nordic Tech House
NextCell Pharma (NXTCL), announces today that the Board, with the authorization of the Annual General Meeting of December 5, 2017, has decided to implement a directed new issue of Nordic Tech House AB ("NTH") of a maximum of approximately SEK 1.5 million. The reasons for the deviation from shareholders' pre-emption rights are to fulfil the company's commitment in accordance with an agreement with Nordic Tech House AB, which was concluded to provide the company with new owners of strategic importance. Current decision replaces previous resolutions on directed new issue from March 13, 2018,
NextCell Pharma (NXTCL), announces today that the Board, with the authorization of the Annual General Meeting of December 5, 2017, has decided to implement a directed new issue of Nordic Tech House AB ("NTH") of a maximum of approximately SEK 1.5 million. The reasons for the deviation from shareh...
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2018-10-31
Publication of year-end report
NextCell Pharma AB (”NXTCL”, “NextCell”) today, released its year-end report for book year 2017/2018 (September 2017 – August 2018). Twelve Months (2017-09-01 until 2018-08-31)  · Net sales amounted to SEK 655 413 (517 203). · Operating result amounted to SEK –14 032 294 (-13 245 206).                   · Result per share amounted to SEK -0,61 (-0,64). · Cash and bank amounted to SEK 3 115 876 (16 600 937). · Solidity amounted to 59 (88) %. · Net sales amounted to SEK 127 868 (198 765). · Operating result amounted to SEK -3 422 282 (-4 757 996).
NextCell Pharma AB (”NXTCL”, “NextCell”) today, released its year-end report for book year 2017/2018 (September 2017 – August 2018). Twelve Months (2017-09-01 until 2018-08-31)  · Net sales amounted to SEK 655 413 (517 203). · Operating result amounted to SEK –14 032 294 (-13 245 206).      ...
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2018-10-25
The Safety Committee recommends proceeding with part 2 of the stem cell trial in type 1 diabetes
The stem cell company NextCell Pharma AB ("NXTCL") today announced that the Data and Safety Monitoring Board recommends Professor Per-Ola Carlsson Academic Hospital, Uppsala University and NXTCL to proceed with the second part of the clinical trial with ProTrans. Patients with type 1 diabetes aged 18-40 years old who had the disease for a maximum of 2 years and who have some own insulin production are candidates to be included in the study. The second part of the ProTrans trial is a Phase-II study with the aim to further evaluate the efficacy and safety of ProTrans. The efficacy of the
The stem cell company NextCell Pharma AB ("NXTCL") today announced that the Data and Safety Monitoring Board recommends Professor Per-Ola Carlsson Academic Hospital, Uppsala University and NXTCL to proceed with the second part of the clinical trial with ProTrans. Patients with type 1 diabetes age...
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2018-10-01
NXTCL’s Cellaviva brand is expanding into Denmark
NextCell Pharma AB ("NXTCL") announced today, that the Cellaviva brand will expand its operations into Denmark. As of 1st October 2018, Cellaviva will offer family stem cell banking there. The idea of family saving of stem cells is already an established business in Denmark and NXTCL estimates that its entrance into Denmark will allow for a doubling of annual sales for Cellaviva. The establishment fits within the existing budget and does not affect NXTCL's capital requirements. Cellaviva has now decided to expand its operations to Denmark as of 1st October 2018. The company holds all the
NextCell Pharma AB ("NXTCL") announced today, that the Cellaviva brand will expand its operations into Denmark. As of 1st October 2018, Cellaviva will offer family stem cell banking there. The idea of family saving of stem cells is already an established business in Denmark and NXTCL estimates th...
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2018-09-20
Redeemed warrants are now registered with the Swedish Companies Registration Office
NextCell Pharma AB ("NXTCL") announced today, 20th September 2018, that the exercised series TO 1 warrants, whose subscription period ended on 13th September 2018, have now been registered with the Swedish Companies Registration Office. A total of 2 720 931 new shares have been registered, which means that the number of shares in NXTCL after registration amounts to 11 226 356. The share capital amounts to SEK 2 301 402.98. Conversion of interim shares to shares is expected to take place on 28th September 2018. Different agents may take a different amount of time to convert, which means that
NextCell Pharma AB ("NXTCL") announced today, 20th September 2018, that the exercised series TO 1 warrants, whose subscription period ended on 13th September 2018, have now been registered with the Swedish Companies Registration Office. A total of 2 720 931 new shares have been registered, which ...
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2018-09-17
NXTCL is allocated approximately SEK 12.9 million through redemption of warrants
During the period 23rd August – 13th September 2018, holders of series TO 1 warrants in NextCell Pharma AB ("NXTCL") have been able to subscribe for shares on the basis of their warrants. In total 2 720 931 warrants of series TO 1 were exercised, which means a subscription rate of 95.11 percent. NXTCL is therefore allocated approx. SEK 13.6 million before issue costs, which are estimated to amount to approx. SEK 0.7 million. CEO Mathias Svahn comments "I would like to thank all of those who have shown - and continue to show - their interest and trust in the stem cell company NXTCL. We
During the period 23rd August – 13th September 2018, holders of series TO 1 warrants in NextCell Pharma AB ("NXTCL") have been able to subscribe for shares on the basis of their warrants. In total 2 720 931 warrants of series TO 1 were exercised, which means a subscription rate of 95.11 percent. ...
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2018-09-11
NextCell to present status of ongoing clinical trial at the Nordic Life Science Days
Stem cell company NextCell Pharma AB ("NXTCL") today presents a status update of its ongoing Phase I/II trial with ProTrans for the treatment of type 1 diabetes. Two out of three patients in the high dose cohort have now undergone treatment and the third patient is scheduled for treatment later this week. NXTCL's clinical trial is divided into two parts, the first part is a three-step dose escalation phase with three patients in each cohort, a total of nine patients. The second part of the trial is randomized, double-blind and placebo-controlled, with ten patients receiving ProTrans and five
Stem cell company NextCell Pharma AB ("NXTCL") today presents a status update of its ongoing Phase I/II trial with ProTrans for the treatment of type 1 diabetes. Two out of three patients in the high dose cohort have now undergone treatment and the third patient is scheduled for treatment later t...
Read moreRead more