PolTREG S.A., an innovative biotechnological company developing therapies using T-regulator cells (TREGS) in the treatment of type 1 diabetes and multiple sclerosis, achieved another significant step closer to the Company’s initiation of key stages of clinical trials.
The Company received a positive response (within the framework of the scientific advice procedure) from the European Medicine Agency on 20 May 2022 concerning the method of manufacture of T-cell preparation for the treatment of patients diagnosed with type 1 diabetes, adopted by the Company.
“We are very pleased that the EMA has confirmed our approach to the way we manufacture our preparation, accepting the methods we use to manufacture and control quality. The EMA has also provided additional scientific guidance on the necessary research and development of the product in the context of the planned clinical trials (type 1 diabetes) with the product and applying for a marketing authorisation in the European Union. Positive responses from EMA allow us to initiate planned clinical trials in type 1 diabetes and multiple sclerosis. They are designed as multicentre clinical trials involving leading clinical sites. The responses received from EMA within the framework of scientific advice confirm the design of the studies adopted by us and the approach to manufacturing products for these trials, and thus constitute a significant factor in managing the risk of non-registration and failure to market the medicine,” said Mariusz Jabłoński, Member of the Management Board of PolTREG S.A.
The clinical trials currently planned by PolTREG will be of multi-center nature. The Company plans to establish competence in the centres with which it cooperates to provide full service to the patient as part of the proposed treatment. For patients during the trials, but also after the product has been registered, this will mean full service in the place where they are treated without the need to travel to the company’s registered office in Gdańsk. Patient will go to their doctor, will have all tests and blood collection done at the site, and once produced, Tregs will be brought back to the treatment where the patient will be administered with it. This means much higher comfort for patients and their physicians. This is also important for the company because its therapy will reach a larger group of patients. This applies both to clinical trials currently in place and the routine offering of this therapy in the future following marketing authorization in the European Union.