NextCell´s publication of the phase I/II clinical trial in type I diabetes accepted

March 28, 2023

NextCell Pharma AB (”NextCell” or ”Company”) have had their article detailing the results of their phase I/II clinical trial in type I diabetes accepted in the peer-reviewed journal Diabetologia.

NextCell Pharma AB (”NextCell” or ”Company”) have had their article detailing the results of their phase I/II clinical trial in type I diabetes accepted in the peer-reviewed journal Diabetologia.

NextCell Pharma AB is a cell therapy company working in the development and commercialization of the mesenchymal stromal cell therapy product, ProTrans. This product, with its proprietary platform technology, is in clinical development for the treatment of autoimmune conditions, such as type I diabetes and inflammatory conditions such as viral pneumonia.

 

NextCell´s seminal study in type 1 diabetes, with their advanced therapeutic medicinal product, ProTrans, has been accepted for publication in the journal Diabetologia. The article, entitled, “Umbilical Cord-Derived Mesenchymal Stromal Cells Preserve Endogenous Insulin Production in Type 1 Diabetes: a Phase I/II Double-blinded, Placebo-controlled, Randomized trial” details how a single infusion of ProTrans can maintain the endogenous production of insulin, slowing the progression of the disease.

 

“It is fantastic to have our first study in type I diabetes published. This study has been the foundation for our clinical development programme in type I diabetes. The study, although small, presents strong data indicative of the effectiveness of ProTrans treatment in slowing diabetic disease development. Based on these data we have moved forward with a pediatric study investigating the efficacy of our drug product in newly diagnosed type I diabetics in the 7-21 age range, ”says Dr Mathias Svahn, CEO for NextCell Pharma.

 

The data reported in the manuscript was generated in collaboration with Professor Per-Ola Carlsson, Principal Investigator at Uppsala University and Karolinska Trial Alliance, Karolinska University Hospital, Huddinge, Sweden(Clinicaltrials.gov identifier NCT03406585).

 

For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel:08-735 5595
E-mail: info@nextcellpharma.com
Website: www.nextcellpharma.com
 LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma
 
 
 
About NextCell Pharma AB
NextCell is a celltherapy company in clinical phase II. The company has developed a proprietary and patented platform technology to produce mesenchymal stromal cells adapted for allogeneic treatment of various autoimmune and immunological diseases. The drug candidate ProTrans is now being tested for the treatment of type-1 diabetes as well as respiratory complications caused by Sars-CoV-2 infection. The focus is to take ProTrans to market approval for type-1 diabetes via a phase III study. ProTrans is evaluated in two clinical COVID-19 studies, in Sweden and Canada. NextCell is working on completing its own GMP facility for the manufacture of ProTrans. The GMP facility is expected to be ready for manufacturing smaller quantities of ProTrans in 2023. NextCell also owns 8.5%of FamicordTX, a start-up company in CAR-T and oncology, and 100% of Cellaviva, Scandinavia's largest stem cell bank for family savings of stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).

 

For more information about NextCell Pharma AB, please contact

Mathias Svahn, CEO
Patrik Fagerholm, CFO

Tel:08-735 5595
E-mail: info@nextcellpharma.com

Website: www.nextcellpharma.com

 LinkedIn: https://www.linkedin.com/company/15255207/

Twitter: https://twitter.com/NextCellPharma

About NextCell Pharma AB

NextCell is a celltherapy company in clinical phase II. The company has developed a proprietary and patented platform technology to produce mesenchymal stromal cells adapted for allogeneic treatment of various autoimmune and immunological diseases. The drug candidate ProTrans is now being tested for the treatment of type-1 diabetes as well as respiratory complications caused by Sars-CoV-2 infection. The focus is to take ProTrans to market approval for type-1 diabetes via a phase III study. ProTrans is evaluated in two clinical COVID-19 studies, in Sweden and Canada. NextCell is working on completing its own GMP facility for the manufacture of ProTrans. The GMP facility is expected to be ready for manufacturing smaller quantities of ProTrans in 2023. NextCell also owns 8.5%of FamicordTX, a start-up company in CAR-T and oncology, and 100% of Cellaviva, Scandinavia's largest stem cell bank for family savings of stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).

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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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