ProTrans and NextCell gain international attention

August 8, 2023

Results from Professor Per-Ola Carlsson, Principal Investigator for NextCell’s Phase-I/II study with ProTrans stromal cells for Type 1 Diabetes are now published and featured in the Up-front section of the current issue of Diabetologia. The article was selected by the Editor as worthy of special attention, for its high quality and interest to the diabetes field. Furthermore, the article has already been cited in an International scientific journal.

 “We are proud that our work is recognized and appreciated by the Editor. This will further increase the international exposure of NextCell”, says Mathias Svahn, CEO

Diabetologia, the official journal of the European Association for the Study of Diabetes (EASD) summarizes the importance of the study on their website:

Umbilical cordderived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase I/II randomised doubleblind placebocontrolled trial
Per-Ola Carlsson, Daniel Espes, Sofia Sisay, Lindsay C. Davies, C. I. Edvard Smith and Mathias G. Svahn

Mesenchymal stromal cells (MSCs) have been shown to modulate the immune system and dampen inflammatory and autoimmune responses in numerous diseases. In this issue, Carlsson et al (https://doi.org/10.1007/s00125-023-05934-3) report their findings from a Phase I/II dose escalation and double-blind placebo-controlled clinical trial investigating the Wharton’s jelly MSC drug product, ProTrans, for the treatment of new-onset type 1 diabetes. In the dose escalation safety study, the authors demonstrate that ProTrans can be safely administered intravenously with no serious adverse events. A fixed dose of 200 million MSCs preserved the production of endogenous insulin and reduced exogenous insulin replacement compared with placebo 1 year after treatment. The authors conclude that a single treatment with ProTrans could potentially delay type 1 diabetes disease progression, thereby reducing the associated complications and improving quality of life.”

In the international scientific journal, Frontiers in Cell and Developmental Biology (June 2023), Hana Drobiova and coworkers list advantages of using stem or stromal cells from the umbilical cord, such as ProTrans, enabling the use of WJ-MSCs as therapeutic agents in regenerative medicine. In particular Professor Carlsson’s clinical trials using allogenic WJ-MSCs to investigate their safety and efficacy are highlighted

The clinical trial with ProTrans is a collaboration with Professor Per-Ola Carlsson, Principal Investigator at Uppsala University and Karolinska Trial Alliance, Karolinska University Hospital, Huddinge, Sweden (Clinicaltrials.gov identifier NCT03406585).

The article is available as open access at https://pubmed.ncbi.nlm.nih.gov/37221247/

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, Head of Cellaviva
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

Certified Adviser
FNCA Sweden AB is assigned as Certified Adviser, info@fnca.se.

About NextCell Pharma AB
NextCell is a cell therapy 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).

Download attachmentRead full press release on Cision (external link)
2020-10-21
ProTrans stem cells approved for clinical trials in COVID-19 patients
NextCell Pharma AB ("NextCell") today announces that the application for clinical trial of COVID-19 patients with the drug candidate ProTrans has been approved by both the Ethics Committy and the Swedish Medical Product Agency. The study will be conducted at the University Hospital in Örebro in collaboration with the Department of Clinical Trials and Karolinska Trial Alliance. ProTrans is developed as an immunomodulatory stem cell therapy presently evaluated in clinical trials treating patients with type-1 diabetes. However, the mechanism of immunomodulation is expected to be applicable in
NextCell Pharma AB ("NextCell") today announces that the application for clinical trial of COVID-19 patients with the drug candidate ProTrans has been approved by both the Ethics Committy and the Swedish Medical Product Agency. The study will be conducted at the University Hospital in Örebro in c...
Read moreRead more
2020-10-14
NextCell presents at “Investerarjakten”
NextCell Pharma AB (“NextCell”) will today at 15:00 present at Investerarjakten. Viewers have the possibility to ask questions directly to CEO Mathias Svahn. The event is broadcast live on Studio Direct's youtube channel, the facebook group Aktier and on Investerarbrevet.se between 13:00-17:00. In September, NextCell published positive data for its Phase II study, ProTrans-2. The patients with type 1 diabetes treated with a dose of the stem cell drug ProTrans had maintained a statistically significantly higher insulin production after 12 months compared with the patients treated with placebo
NextCell Pharma AB (“NextCell”) will today at 15:00 present at Investerarjakten. Viewers have the possibility to ask questions directly to CEO Mathias Svahn. The event is broadcast live on Studio Direct's youtube channel, the facebook group Aktier and on Investerarbrevet.se between 13:00-17:00. ...
Read moreRead more
2020-09-10
Presentation of the positive results from ProTrans-2
NextCell Pharma AB ("NextCell") announced earlier this week that the clinical diabetes trial ProTrans-2 had met the primary endpoints. On the occation of that, the principal investigator Professor Per-Ola Carlsson together with NextCell will hold a webcast presentation today, Thursday 10 September at 16.00. The result from the clinical trial ProTrans-2 said that patients treated with a single dose ProTrans show a statistically significant improved preservation of insulin production over 12 months, compared to patients treated with placebo (p-value < 0.05). Today, on Thursday the 10th of
NextCell Pharma AB ("NextCell") announced earlier this week that the clinical diabetes trial ProTrans-2 had met the primary endpoints. On the occation of that, the principal investigator Professor Per-Ola Carlsson together with NextCell will hold a webcast presentation today, Thursday 10 Septembe...
Read moreRead more
2020-09-08
ProTrans shows significant effect in Diabetes
NextCell Pharma AB ("NextCell") today announces that the ProTrans-2 clinical trial met the primary endpoint. Patients treated with a single dose ProTrans show a statistically significant improved preservation of insulin production over 12 months, compared to patients treated with placebo (p-value < 0.05). A total of 15 patients were included in the ProTrans-2 trial. They were randomized to receive either ProTrans (n=10), NextCell’s proprietary stem cell therapy, or placebo (n=5). Treatment was blinded, ensuring that neither patients or their physicians knew whether they had received active
NextCell Pharma AB ("NextCell") today announces that the ProTrans-2 clinical trial met the primary endpoint. Patients treated with a single dose ProTrans show a statistically significant improved preservation of insulin production over 12 months, compared to patients treated with placebo (p-value...
Read moreRead more
2020-08-03
NextCell announces Eurostars grant for developing an innovative cell therapy production platform
NextCell Pharma AB (“NextCell” or the “Company”) announces today that the Company together with 3 partner organizations have been awarded a €1.6M Eurostars grant of which NextCell’s share is €470,000. The aim of the project entitled Bioscale, is to optimise automated bioreactors to manufacture the drug candidate ProTrans. The SCINUS expansion system presents cost-efficient cell culturing, designed for standardised cell therapy production, leading to improved quality consistency and reduced cost. · NextCell has been granted €470,000 of a Eurostar grant totalling €1.6M. The total budget of the
NextCell Pharma AB (“NextCell” or the “Company”) announces today that the Company together with 3 partner organizations have been awarded a €1.6M Eurostars grant of which NextCell’s share is €470,000. The aim of the project entitled Bioscale, is to optimise automated bioreactors to manufacture th...
Read moreRead more
2020-07-31
NextCell Pharma AB publishes its interim report for September 2019 - May 2020
NextCell Pharma AB (publ) (NXTCL) today announces that its Interim report for the period September 1, 2019 - May 31, 2020 now is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report Nine months (2019-09-01 until 2020-05-31) · Operating income amounted to SEK 3 191 314 (1 273 201). · Operating result amounted to SEK -12 803 349 (-13 477 202). · Earnings per share* amounted to SEK -1,11 (-1,17). · Cash and bank amounted to SEK 5 612 952 (2 249 092). In addition, after the end of the period, in June 2020, the Company received an
NextCell Pharma AB (publ) (NXTCL) today announces that its Interim report for the period September 1, 2019 - May 31, 2020 now is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report Nine months (2019-09-01 until 2020-05-31) · Operating income amounted...
Read moreRead more
2020-07-06
NextCell approved for trading on Nasdaq First North
NextCell Pharma AB (publ) (“NextCell” or “the Company”) announces that Nasdaq Stockholm AB today has approved their application for trading on Nasdaq Stockholm First North. The last day for trading on Spotlight is Tuesday, July 21, 2020 and the first day for trading on Nasdaq First North is Wednesday, July 22, 2020. The shares in NextCell will be traded with unchanged ticker (NXTCL) and ISIN code (SE0009723125) and shareholders in NextCell need not take any action in connection with the list change. "The list change is a natural step in our development and is expected to attract a broader
NextCell Pharma AB (publ) (“NextCell” or “the Company”) announces that Nasdaq Stockholm AB today has approved their application for trading on Nasdaq Stockholm First North. The last day for trading on Spotlight is Tuesday, July 21, 2020 and the first day for trading on Nasdaq First North is Wedne...
Read moreRead more
2020-06-24
NextCell Pharma AB’s rights issue heavily oversubscribed
The Board of Directors of NextCell Pharma AB ("NextCell" or the “Company”) announces today the outcome in the Company’s new issue of shares with preferential rights for existing shareholders (the “Rights Issue”). The demand was high and the Rights Issue was oversubscribed. Thus, no guarantees have been utilized. Through the Rights Issue, the Company receives approximately SEK 25.1 million before transaction costs. · 4,111,192 shares were subscribed using subscription rights · In addition, applications for subscription without using subscription rights corresponding to 11,750,102 shares
The Board of Directors of NextCell Pharma AB ("NextCell" or the “Company”) announces today the outcome in the Company’s new issue of shares with preferential rights for existing shareholders (the “Rights Issue”). The demand was high and the Rights Issue was oversubscribed. Thus, no guarantees hav...
Read moreRead more