Clinical Trials

cell therapy/gene therapy/immunotherapy product. This mesenchymal stromal cells 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 the tumor, or its metastases, where the cytotoxic gene product is selectively activated, increasing local efficacy with reduced systemic toxicity, one of the main problems of systemic chemotherapy.

* On March 26, 2015, apceth announced  the successful completion of the Phase I and initiation of the Phase II part of its ongoing monocentric  Phase I/II clinical trial TREAT-ME 1 with the engineered cell therapeutic product agenmestencel-T, at  the Klinikum Grosshadern in Munich. To the company’s knowledge, 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.
apceth has initiated the Phase II part of the trial using the high-dose treatment regime as evaluated  in the Phase I trial. The open label study will include ten advanced gastrointestinal cancer patients  and will evaluate the safety and tolerability of Agenmestencel-T and its efficacy based on RECIST  criteria, with the aim to establish proof of concept of this novel technology in late-stage cancer  patients. In parallel, six patients will be treated prior to tumor resection surgery, without subsequent  ganciclovir administration, and tumor biopsies will be analyzed for presence of the genetically  modified MSCs.
The completed Phase I trial included six patients suffering from advanced-stage gastrointestinal adenocarcinomas (3 colorectal, 2 pancreatic, and 1 cholangiocellular carcinoma). Top-line data  applied cell therapy analysis confirmed the infusion of the engineered cells and the treatment was safe and tolerable.  apceth anticipates presenting the full data from the Phase I trial later in 2015.

* On January 23, 2014,  apceth has announced that the TREAT ME Phase I/II clinical trial for patients suffering from advanced adenocarcinoma of the gastro-intestinal tract has commenced. This is the first clinical trial world-wide with genetically-modified mesenchymal stromal cells (MSCs).