After successfully complete phase I clinical study, apceth initiates the Phase II of world’s first genetically-engineered cell therapy. The ongoing monocentric Phase I/II clinical trial TREAT-ME 1 with the engineered cell therapeutic product Agenmestencel-T, will take place at the Klinikum Grosshadern in Munich. This is the first time that a genetically engineered Mesenchymal Stem Cell (MSC) treatment has successfully completed a Phase I clinical trial and been approved to initiate a Phase II trial. The first patient in the Phase II trial has already been treated.
Agenmestencel-T next-generation MSC therapy is based on cells harvested from the patient’s own (autologous) bone marrow, which are processed, genetically modified, and re-infused into the patient. The cells specifically target tumors or metastases, and, upon reaching the target tissue, the cytotoxic gene product is selectively activated, increasing local efficacy with reduced systemic toxicity.
Dr. Christine Günther, apceth’s CEO, said: “apceth is pioneering a transformative approach to cell-based therapies and we see this trial start as an important validation of both the safety and therapeutic potential of our technology.