“We are in the process of preparing for the next stages of clinical trials. Although we have the production capacity to start them immediately, we prefer to use preparations manufactured at our new state-of-the-art plant currently being under the final stages of construction. This is critical because the European Medicines Agency (EMA) places a strong emphasis on the quality, safety and efficacy of any new cell and gene therapy products. We therefore believe that it is important for the successful future regulatory process and clinical trials, to have the preparation produced in a single large scale manufacturing facility,” – said Prof. Piotr Trzonkowski, CEO of PolTREG.
“Later this year, we plan to initiate discussions with pharmaceutical companies that may be responsible for distributing our therapy. Our goal is to reach agreement on the details of this process before starting the study” – said Mariusz Jablonski, a member of the management board at PolTREG.