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)
2025-07-24
NextCell Pharma publishes its Interim Report 3 2024/2025
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 3 for the period March 1, 2025 – May 31, 2025. This English version of the Interim Report is a translation of the Swedish version. The Swedish version is the official version. 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
2025-07-14
NextCell Highlighted in FUJIFILM’s Strategic Vision, According to GEN
NextCell Pharma AB (“NextCell” or “the Company”) is pleased to announce that its strategic collaboration with FUJIFILM Biosciences has been highlighted in an article published on 8 July by Genetic Engineering & Biotechnology News (GEN). The article covers FUJIFILM’s recent rebranding and long-term ambition to act as a full-spectrum partner to drug and vaccine developers throughout the entire development cycle.
Read moreRead more
2025-07-03
Republishing of: NextCell announces strategic collaboration with FUJIFILM Biosciences
NextCell Pharma AB’s ("NextCell" or "the Company") has entered into a strategic collaboration with FUJIFILM Biosciences Inc. to bring together their core competences in mesenchymal stromal cells (MSCs) and raw materials for the life science sector. The aim of the collaboration is to provide researchers and developers in the cell therapy field with an integrated offering – standardised MSC products, optimised culture media, and cryopreservation solutions.
Read moreRead more
2025-06-13
All Patients Successfully Treated in ProTrans-Young Study
NextCell Pharma AB ("NextCell" or the "Company") announces today that all patients in the ongoing ProTrans-Young clinical trial have now successfully been treated. This milestone marks the completion of patient dosing in the company’s largest clinical study to date. ProTrans-Young is evaluating the safety and efficacy of the Company’s lead cell therapy candidate, ProTrans, in paediatric and adolescent patients with recently diagnosed type 1 diabetes.
Read moreRead more
2025-06-02
NextCell Pharma announces outcome of exercise of TO2 and resolves on directed share issues to guarantors
THIS PRESS RELEASE MAY NOT BE RELEASED, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, JAPAN, NEW ZEALAND, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND, CANADA, HONG KONG, BELARUS, RUSSIA OR IN ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLISHING OR DISTRIBUTION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTATION OR OTHER MEASURES IN ADDITION TO THOSE REQUIRED BY SWEDISH LAW. SEE SECTION "IMPORTANT INFORMATION" AT THE END OF THIS PRESS RELEASE. NextCell Pharma AB (“NextCell” or the “Company”) today announces the outcome of the exercise of warrants of series TO2 (the “Warrants”), which were issued in connection with the Company’s rights issue of units during the second quarter of 2024. In total, 24,945,532 Warrants have been exercised, corresponding to approximately 64.4 percent of the total number of outstanding Warrants, for subscription of 24,945,532  shares at subscription price of SEK 1.00 per share. As a result, guarantee commitments of 11,614,000 shares, corresponding to approximately SEK 11.6 million, have been utilized. Thus, the board of directors of the Company has resolved on a directed issue of 11,614,000 shares (the “Directed Issue”) to the investors who had provided guarantee commitments. Through the exercise of Warrants and the Directed Issue, the Company will receive total proceeds of approximately SEK 36.6 million before deduction of issue-related costs. Furthermore, the board of directors has resolved on a set-off issue of 1,742,100 shares to the guarantors to pay the guarantee compensation (the "Remuneration Issue").
Read moreRead more
2025-05-28
NextCell Pharma receives additional declarations of intent regarding exercise of TO2
THIS PRESS RELEASE MAY NOT BE RELEASED, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, JAPAN, NEW ZEALAND, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND, CANADA, HONG KONG, BELARUS, RUSSIA OR IN ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLISHING OR DISTRIBUTION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTATION OR OTHER MEASURES IN ADDITION TO THOSE REQUIRED BY SWEDISH LAW. SEE SECTION "IMPORTANT INFORMATION" AT THE END OF THIS PRESS RELEASE. NextCell Pharma AB ("NextCell" or the "Company") today announces that the Company has received additional non-binding declarations of intent regarding the exercise of warrants of series TO2 (“Warrants”). The new declarations correspond to approximately SEK 5.5 million, equivalent to approximately 14.1 percent of the total number of outstanding Warrants. In total, the Company has now received declarations of intent, subscription undertakings, and guarantee commitments amounting to approximately SEK 24.0 million, corresponding to approximately 61.9 percent of the total issue volume.
Read moreRead more
2025-05-28
Angela Vollstedt joins NextCell Pharma’s Board of Advisors to Strengthen Scientific and Manufacturing Strategy Ahead of Licensing Discussions
NextCell Pharma AB ("NextCell" or "the Company") is pleased to announce the appointment of Dr. Angela Vollstedt, PhD, MBA, to its Board of Advisors, reinforcing the company’s strategic shift toward pivotal development and licensing of its lead drug candidate, ProTrans, for the treatment of type 1 diabetes. Dr. Vollstedt currently serves as Global Director of Cell & Gene Therapies Portfolio Management at Novartis, where she leads cross-functional teams in the development, scaling, and commercialisation of advanced therapies.
Read moreRead more
2025-05-26
NextCell Receives US Patent for MSC Prediction Algorithm
NextCell Pharma AB ("NextCell" or "the Company") is pleased to announce the issuance of a US patent titled “MSC Prediction Algorithm” by the United States Patent and Trademark Office (USPTO). The patent protects NextCell’s innovative methodology for predicting the efficacy of mesenchymal stromal cell (MSC) therapy in individual patients, as well as the approach for determining personalised treatment options based on that prediction.
Read moreRead more