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)
2020-06-09
NextCell's phase II study is completed – a phase III is being prepared
NextCell Pharma AB ("NextCell") announces that the last patient now has left ProTrans-2, meaning the phase II trial with the drug candidate ProTrans for treatment of type 1 diabetes, is completed according to plan. Data will be compiled and analyzed by independent statistician to be presented during the third quarter. “NextCell is now preparing a phase III trial in order to reach the market as soon as possible, in case of a positive result of the phase II study”, says Mathias Svahn, CEO. NextCell's drug candidate, ProTrans ™, developed for the treatment of type 1 diabetes, has, in
NextCell Pharma AB ("NextCell") announces that the last patient now has left ProTrans-2, meaning the phase II trial with the drug candidate ProTrans for treatment of type 1 diabetes, is completed according to plan. Data will be compiled and analyzed by independent statistician to be presented dur...
Read moreRead more
2020-06-03
NextCell Pharma AB publishes prospectus relating to the rights issue and announces the intention of change of listing to Nasdaq First North in July
The Board of Directors of NextCell Pharma AB ("NextCell" or the “Company”) has prepared a prospectus (the “Prospectus”) relating to the new issue of shares with preferential rights for existing shareholders of approximately SEK 25.1 million (the Rights Issue”), which was resolved by the Board of Directors on 15 May 2020 and approved by the extraordinary general meeting on 3 June 2020. The Prospectus has today been approved and registered by the Swedish Financial Supervisory Authority. Today, the Company also announces the intention of change of listing. The Company has obtained conditional
The Board of Directors of NextCell Pharma AB ("NextCell" or the “Company”) has prepared a prospectus (the “Prospectus”) relating to the new issue of shares with preferential rights for existing shareholders of approximately SEK 25.1 million (the Rights Issue”), which was resolved by the Board of ...
Read moreRead more
2020-05-28
Invited to panel discussion; Post-Covid-19 world
NextCell Pharma AB ("NextCell") has been invited to participate in the panel discussion entitled “The impact of corona virus on the global healthcare - new challenges and main problems”. Doctor Lindsay Davies, Chief Scientific Officer at NextCell and researcher at Karolinska Institutet will join the panel. Today, 28[th] of May, international experts are having a one-day video conference. The conference is hosted by the Polish Medical Research Agency, Ministry of Health, Ministry of Development and is organized by the Kulski Foundation. The panel discussion is at 15:15 with opening speech
NextCell Pharma AB ("NextCell") has been invited to participate in the panel discussion entitled “The impact of corona virus on the global healthcare - new challenges and main problems”. Doctor Lindsay Davies, Chief Scientific Officer at NextCell and researcher at Karolinska Institutet will join ...
Read moreRead more
2020-05-15
The Board of Directors of NextCell Pharma AB resolves on a fully guaranteed SEK 25.1 million rights issue
NextCell Pharma AB ("NextCell" or the “Company”) announces that the Board of NextCell Pharma AB has resolved to conduct a fully guaranteed new issue of shares of approximately SEK 25.1 million with preferential rights for the Company's existing shareholders (the "Rights Issue"), subject to approval by an extraordinary general meeting in the Company. The Company’s largest shareholder Diamyd Medical AB and chairman of the Boad of Directors Anders Essen-Möller have undertaken to subscribe for their pro rata share in the Rights Issue. In total, the Rights Issue is covered by subscription
NextCell Pharma AB ("NextCell" or the “Company”) announces that the Board of NextCell Pharma AB has resolved to conduct a fully guaranteed new issue of shares of approximately SEK 25.1 million with preferential rights for the Company's existing shareholders (the "Rights Issue"), subject to approv...
Read moreRead more
2020-04-29
NextCell Pharma AB publishes its interim report for September 2019 - February 2020
NextCell Pharma AB (publ) (NXTCL) today announces that its Interim report for the period September 1, 2019 - February 29, 2020 now is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-reports Second quarter (2019-12-01 until 2020-02-29) · Operating income amounted to SEK 1 364 645 (435 051). · Operating result amounted to SEK -4 228 449 (-3 552 444). · Earnings per share* amounted to SEK -0,22 (-0,31). · Cash and bank amounted to SEK 10 700 725 (6 886 879). · Solidity** amounted to 80,2 (85,0) %. First six month (2019-09-01
NextCell Pharma AB (publ) (NXTCL) today announces that its Interim report for the period September 1, 2019 - February 29, 2020 now is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-reports Second quarter (2019-12-01 until 2020-02-29) · Operating income...
Read moreRead more
2020-03-20
NextCell in discussions about patients with covid-19
NextCell Pharma AB ("NextCell") announces that parallel discussions with several hospitals have been initiated to treat patients with covid-19, the severe respiratory tract infection caused by the new coronavirus, with the stem cell product ProTrans. “We would like to emphasize that this information is preliminary. There are both administrative and regulatory challenges, but the intention from healthcare is to go forward with this. We will come back when and if further information is available, says Mathias Svahn, CEO of NextCell. "We advise against speculative share purchases in the
NextCell Pharma AB ("NextCell") announces that parallel discussions with several hospitals have been initiated to treat patients with covid-19, the severe respiratory tract infection caused by the new coronavirus, with the stem cell product ProTrans. “We would like to emphasize that this informa...
Read moreRead more
2020-03-11
The stem cell company NextCell Pharma is preparing for a pivotal phase III trial
NextCell Pharma AB ("NextCell") announces that CEO Mathias Svahn will present a status update of the ongoing clinical trials at the Stockholm Corporate Finance Life Science Seminar held at Berns in Stockholm today, March 11. NextCell Pharma is currently running two parallel trials with ProTrans (Protrans-1 Phase I/II and ProTrans-Repeat) for the treatment of patients with type 1-diabetes. Ten out of a total of 15 patients in the phase II part of ProTrans-1 (ProTrans 2) have now left the trial and the last patient's last visit is scheduled for the end of June/July 2020. Thereafter, data will
NextCell Pharma AB ("NextCell") announces that CEO Mathias Svahn will present a status update of the ongoing clinical trials at the Stockholm Corporate Finance Life Science Seminar held at Berns in Stockholm today, March 11. NextCell Pharma is currently running two parallel trials with ProTrans (...
Read moreRead more
2020-02-21
The stem cell company NextCell Pharma participates as a reference laboratory in NIBSC study
NextCell Pharma AB ("NextCell") announces today, that it has acted as a reference laboratory to assist National Institute for Biological Standards and Control (NIBSC) in the development of a reference reagent for Mesenchymal Stem The NIBSC is a UK based entity and a global leader when it comes to the characterisation, standardisation and control of biological medicines. As part of their activities the NIBSC has been endorsed by the World Health Organization (WHO) to develop and generate a reference for MSCs. The official name of the study/assignment is: “International Collaborative Study to
NextCell Pharma AB ("NextCell") announces today, that it has acted as a reference laboratory to assist National Institute for Biological Standards and Control (NIBSC) in the development of a reference reagent for Mesenchymal Stem The NIBSC is a UK based entity and a global leader when it comes to...
Read moreRead more