NextCell Pharma AB (“NextCell”) today announces that the application for clinical trial of COVID-19 patients with the drug candidate ProTrans has been approved by both the Ethics Committy and the Swedish Medical Product Agency. The study will be conducted at the University Hospital in Örebro in collaboration with the Department of Clinical Trials and Karolinska Trial Alliance.
ProTrans is developed as an immunomodulatory stem cell therapy presently evaluated in clinical trials treating patients with type-1 diabetes. However, the mechanism of immunomodulation is expected to be applicable in other autoimmune diseases and inflammatory conditions. The server stage of COVID-19 is when the immune system becomes hyperactive and attacks organs including the lungs. In this open phase 1b study, a total of three groups of, each three patients, will be treated with different doses of ProTrans.
Principle Investigator for the trial is Professor Josefin Sundh, University Hospital Örebro. The clinical trial protocol is written by Professor Dominique Farge, St. Louis Hospital in France, and Doctor Lindsay Davies, CSO NextCell Pharma. The steering committee is Professor Farge (chair), Professor Edvard Smith (NextCell Pharma) and Doctor Tomasz Oldak (PBKM). NextCell decided to subcontract PBKM (FamiCord Group) as Contracted Manufacturing Partner.
This information is the information that NextCell Pharma AB is required to disclose under the EU Market Abuse Regulation. The information was provided by the below contact person for publication on 21st of October 2020
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About NextCell Pharma AB
NextCell is a Phase II cell therapy company with the lead candidate ProTrans™, for the treatment of type-1 diabetes. Focus is to take ProTrans™ to market approval via a phase III study. Furthermore, NextCell operates Cellaviva, Scandinavia’s largest stem cell bank for family-saving of stem cells from umbilical cord blood and umbilical cord tissue with permission from IVO.
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