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 attachmentRead full press release on Cision (external link)
2023-08-08
ProTrans and NextCell gain international attention
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.
Read moreRead more
2023-07-27
NextCell publishes its Interim Report 3 2022/2023
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 3 for the period March 1, 2023 – May 31, 2023 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 Market under the ticker "NXTCL". The amount in brackets refers to the corresponding period in the previous year.  
Read moreRead more
2023-07-05
Treatment start of severe pneumonia with high dose of ProTrans
NextCell Pharma AB ("NextCell" or the "Company") announces that the clinical trial ProTrans 19+SE (also called Protrans V) can start recruiting patients in the high dose group, which is the last dose group. Three patients treated with medium dose of ProTrans have been clinically evaluated and the data has been reviewed by the Data Safety Monitoring Board, which now allows continued treatment with high-dose ProTrans for severe pneumonia caused by COVID-19, Influenza, Human Metapneumovirus and RSV.
Read moreRead more
2023-05-30
NextCell invited presenter at International Society for Cell and Gene Therapy meeting in Paris
NextCell Pharma AB's ("NextCell" or the"Company") CSO, Dr Lindsay Davies, has been invited to give a poster presentation at the ISCT meeting in Paris, showcasing NextCell´s long-term follow-up data from their phase II type I diabetes study with investigative medicinal product, ProTrans.
Read moreRead more
2023-04-27
NextCell publishes its Interim Report 2 2022/2023
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period December 1, 2022 – February 28, 2023 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 Market under the ticker "NXTCL". The amount in brackets refers to the corresponding period in the previous year.  
Read moreRead more
2023-04-26
Breakthrough multiplication of blood stem cells
NextCell Pharma AB (“NextCell” or the “company") announces that the FDA has approved a product of multiplied stem cells from umbilical cord blood. It is a breakthrough that could lead to increased interest in saving stem cells for private use, where Cellaviva is the market leader in Scandinavia. Cellaviva is a part of NextCell with offices in Stockholm and Copenhagen.
NextCell Pharma AB (“NextCell” or the “company") announces that the FDA has approved a product of multiplied stem cells from umbilical cord blood. It is a breakthrough that could lead to increased interest in saving stem cells for private use, where Cellaviva is the market leader in Scandinavia.
Read moreRead more
2023-04-18
NextCell invited speaker at European Wound Management Association Meeting in Milan
NextCell Pharma AB´s ("NextCell" or the "Company") CSO, Dr Lindsay Davies, has been invited to give a presentation at the EWMA meeting in Milan, showcasing NextCell´s phase II clinical data with their investigative medicinal product, ProTrans, in slowing the progression of type-1 diabetes.
NextCell Pharma AB´s ("NextCell" or the "Company") CSO, Dr Lindsay Davies, has been invited to give a presentation at the EWMA meeting in Milan, showcasing NextCell´s phase II clinical data with their investigative medicinal product, ProTrans, in slowing the progression of type-1 diabetes.
Read moreRead more
2023-03-28
NextCell´s publication of the phase I/II clinical trial in type I diabetes accepted
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.
Read moreRead more