ProTrans study in COVID-19 expanded to include treatment of severe pneumonia induced by influenza A, RSV and HMP virus

January 25, 2023

NextCell Pharma AB ("NextCell") today announces that the Swedish Medical Products Agency has approved the expansion of their Swedish COVID-19 study, to include patients with severe pneumonia due to influenza A, respiratory syncytial virus (RSV) and human metapneumovirus (HMP).The treatment is aimed at patients who are hospitalized and at high risk of needing ventilator life support. ProTrans is given intravenously to suppress hyperinflammation in the lungs. The goal of treatment is to shorten hospitalization and time for rehabilitation, and to save lives.

"Expansion with three common emerging viruses greatly increases ProTrans'  potential future use case.  There is reason to believe that lung disease is a particularly well-suited area for ProTrans as infused stromal cells are well documented to traffic to the lungs. ProTrans is given to treat a complication, pneumonia, or hyperinflammation of the lung, which manifests inbreathing difficulties and injury to the lung irrespective of which virus causes it," says Mathias Svahn, CEO.

ProTrans19+SE is carried out at the University Hospital in Örebro in collaboration with the Division of Clinical Trials and Karolinska Trial Alliance. The Principal Investigator is Associate Professor Josefin Sundh. So far, a total of 5 patients with SARS-CoV-2 infection have been treated.

Full revised study title is: " Treatment of Respiratory Complications Associated withCOVID-19, Influenza A, Metapneumovirus, Respiratory Syncytial Virus (RSV)Infection Using Wharton's Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®): a Randomized Phase IB Controlled Clinical Trial", (EudraCT2020-002078-29). NextCell is sponsoring the study which will include nine patients with severe pneumonia and confirmed viral infection, who are treated with low  dose (3 patients) medium dose(3 patients)  and high dose (3 patients)of ProTrans.  

The study is registered on clinicaltrials.gov with number NCT04896853.


For further information about NextCell, please contact:

Mathias Svahn, CEO
Patrik Fagerholm, CFO
Phone: 08-735 5595
E-mail: info@nextcellpharma.com
Website:www.nextcellpharma.com
 
LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma

 

Certified Adviser

FNCA Sweden AB is appointed Certified Adviser, 08-528 00 399, 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 stem 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 and respiratory complications caused by Sars-CoV-2 infection. The focus is to take ProTrans to a market approval for type-1 diabetes via a phase III study. ProTrans is also used 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 attachment
2023-01-26
NextCell publishes its Interim Report 1 2022/2023
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 1 for the period September 1, 2022 – November 30, 2022 The report is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report. NextCells share is traded on Nasdaq First North Growth Ma
Read moreRead more
2023-01-25
ProTrans study in COVID-19 expanded to include treatment of severe pneumonia induced by influenza A, RSV and HMP virus
NextCell Pharma AB ("NextCell") today announces that the Swedish Medical Products Agency has approved the expansion of their Swedish COVID-19 study, to include patients with severe pneumonia due to influenza A, respiratory syncytial virus (RSV) and human metapneumovirus (HMP). The treatment is aimed
Read moreRead more
2023-01-18
Positive feedback on the paediatric plan of the EMA
NextCell Pharma AB ("NextCell") has received positive comments and recommendations for the pediatric investigational plan (PIP) submitted to the Europeans Medicines Agency’s (EMA) pediatric committee (PDCO).
Read moreRead more
2022-12-21
First pediatric patients treated with ProTrans in type-1 diabetes phase II study
NextCell Pharma AB ("NextCell") supports the pediatric diabetes clinical trial conducted at Uppsala University Hospital by Principal Investigator Professor Per-Ola Carlsson with the stromal cell treatment, ProTrans. At the end of October 2022, the Data Safety and Monitoring Board recommended that ph
Read moreRead more
2022-10-27
NextCell presentation of Interim analysis data today at 15:00
NextCell Pharma AB ("NextCell" or the "Company") has developed a proprietary and patented platform technology where stem cells can be selected for allogeneic treatment of various specific diseases. CEO Mathias Svahn will present the results on Thursday, October 27 at 15:00 CET, which will be broadca
Read moreRead more
2022-10-27
NextCell publishes its Year-End Report 2021/2022
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Year-End Report for the period September 1, 2021 – August 31, 2022 The report is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report. NextCells share is traded on Nasdaq First North Growth Marke
Read moreRead more
2022-10-24
NextCell cell therapy shows long-term effect in two independent diabetes studies "ProTrans-Repeat" and "ProTrans-Obs" – live presentation
NextCell Pharma AB ("NextCell" or the "Company") has developed a proprietary and patented platform technology where stem cells can be selected for allogeneic treatment of various specific diseases. CEO Mathias Svahn will present the results on Thursday, October 27 at 15:00 CET, which will be broad
Read moreRead more
2022-10-20
ProTrans cell therapy provides long-term effect in type-1 diabetes with a single treatment
NextCell Pharma AB ("NextCell" or the "Company") today announces that patients who 3 years ago were treated with ProTrans in the phase II study ProTrans-2 have maintained significantly higher endogenous insulin production than patients who received placebo, (63% compared to 23%). The results from th
Read moreRead more