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).

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2019-05-09
ProTrans-Repeat, an approved clinical trial for repeated treatment of patients with diabetes
The Medical Products Agency has granted NextCell Pharma AB ("NextCell") permission to conduct the new study, ProTrans-Repeat. The study is a continuation of ProTrans-1 where patients with type-1 diabetes who participated in the dose escalation part will be asked to participate in ProTrans-Repeat. The purpose is to investigate whether repeated treatment is safe and gives increased effect on the patient's ability to produce insulin. ProTrans-Repeat is a Phase IIa clinical trial that aims to evaluate whether repeated treatment can increase or maintain the effect of ProTrans over a longer period
The Medical Products Agency has granted NextCell Pharma AB ("NextCell") permission to conduct the new study, ProTrans-Repeat. The study is a continuation of ProTrans-1 where patients with type-1 diabetes who participated in the dose escalation part will be asked to participate in ProTrans-Repeat....
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2019-05-08
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NextCell Pharma AB ("NextCell") today received a permit from the Medical Products Agency granting permission to initiate a new clinical trial, called ProTrans-Repeat. The trials is a continuation of the ongoing ProTrans-1 trial and of great importance to the further development of ProTrans. The goal for this study is to include those patients with type 1 diabetes who participated in the dose escalation part of the ongoing ProTrans-1 study and the study purpose is to demonstrate that ProTrans also has a positive effect when using a repeated treatment approach. ProTrans-Repeat is a Phase IIa
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The Board of NextCell Pharma AB (publ) ("NextCell" or "the Company") has decided to propose an extraordinary general meeting on May 24, 2019 to decide on a rights issue of shares ("Rights Issue") totaling SEK 24.9 million. The rights issue is secured through subscription commitments and letter of...
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2019-04-30
Half-year report
First Half (2018-09-01 till 2018-02-28) · Operating income amounted to SEK 508,7795 (391,204). · Operating result amounted to SEK -8,929,084 (-7,524,256).                         · Earnings per share* amounted to SEK -0.83 (-0.88). · Cash and bank amounted to SEK 6,886,879 (9,444,381). · Solidity** amounted to 87 (59) %. **Result per share: operating results divided by the average number of shares. Average number of shares for the first half of 2018/2019: 11,486,456 shares (8,505,425). Number of shares in NextCell as per February 28th, 11,486,456 shares (8,505,425). *
First Half (2018-09-01 till 2018-02-28) · Operating income amounted to SEK 508,7795 (391,204). · Operating result amounted to SEK -8,929,084 (-7,524,256).                         · Earnings per share* amounted to SEK -0.83 (-0.88). · Cash and bank amounted to SEK 6,886,879 (9,444,381). ...
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2019-04-26
NextCell Pharma AB comments on the trading halt of 25 April 2019
With respect to Spotlight Stock Market’s decision on 25 April 2019 to halt trading in NextCell Pharma AB's share, the stock market has, in accordance with its regulations, ordered the company to comment on the trading halt. Discussions are currently underway between the boards of NextCell Pharma AB and Idogen AB regarding a potential merger. The structure being discussed would entail that NextCell Pharma AB makes a bid for all of the shares in Idogen AB and in turn will offer its own shares as a means of payment. At the time of the press release, the dialogue between the companies has only
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2019-04-05
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