Clinical Trials

Date: 2018-10-19

Type of information: Presentation of results at a congress

phase: preclinical

Announcement: presentation of results at the Annual Congress of the European Society of Gene and Cell Therapy

Company: apceth (Germany)

Product: apceth-201

Action mechanism:

  • cell therapy.  apceth-201 are allogeneic human mesenchymal stromal cells (MSCs) that have been genetically modified to express alpha-1 antitrypsin (AAT), a protease inhibitor exerting potent anti-inflammatory and tissue-protective functions to further augment the immunomodulatory potential of MSCs. These cells have potent immunomodulatory and anti-inflammatory properties. This therapy:
  • -inhibits secretion of proinflammatory citokines,
  • -suppresses T-cell proliferation
  • -reduces NK cell-mediated cell killing
  • -shows positive impact on long-term immunoregulation by targeting both the adaptative and innate arm of the immune system.
  • apceth™-201  targets diseases with pathology based on chronic inflammation and/or autoimmune process, such as Graft-vs-Host Disease (GvHD), inflammatory bowel disease (IBD), diabetes type I, vasculitis or chronic lung disease (COPD)

Disease: acute graft-versus-host disease (aGvHD)

Therapeutic area: Transplantation


Trial details:

Latest news:

  • • On October 19, 2018, apceth Biopharma announced positive results for apceth-201 in mouse models for acute graft-versus-host disease (aGvHD). The data was highlighted in a poster presentation at the Annual Congress of the European Society of Gene and Cell Therapy in Lausanne on October 16-19. apceth Biopharma is currently preparing to  initiate a phase 1/2 clinical study assessing the safety and efficacy of apceth-201 in adult steroid-refractory GvHD patients.
  • Results presented at the ESGCT indicate that  apceth-201 significantly improved clinical score and overall survival in two aGvHD models. In a humanized model vehicle-treated control animals succumbed quickly to GvHD, whereas median survival was doubled in apceth-201-treated animals. Mice receiving apceth-201 showed significantly improved clinical scores, a striking amelioration of bone marrow cellularity, and reduced levels of inflammatory markers. apceth-201 was further tested in a GvHD model system which closely mimics haploidentical HSCT. Vehicle-treated control animals again succumbed quickly to GvHD, whereas treatment with apceth-201 resulted in long-term survival of 57 % of the mice. Initially, all apceth-201-treated animals exhibited clinical scores comparable to the control animals. However, within a period of 25 days after the second cell injection, the clinical scores had returned to baseline, indicating complete resolution of GvHD.

Is general: Yes