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).
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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”) issued a total of 38,711,804 warrants of series TO2 (“Warrants”) within the framework of a rights issue of units during the second quarter of 2025. The exercise period for the Warrants commences today, on May 16, 2025, and continues until May 30, 2025. One (1) Warrant entitles the holder to subscribe for one (1) new share in the Company. The subscription price per share subscribed for through the exercise of Warrants has been set at SEK 1.00. Upon full utilization of all Warrants, NextCell will receive approximately SEK 38.7 million before issuance costs. The proceeds from the exercise of Warrants are mainly intended to support the completion of the ProTrans-Young study and continued clinical development, business development, and regulatory preparations for future market approval.
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