CLINICAL TRIALS


apceth is implementing innovative cell-based gene therapies into clinical trials of all phases and stages of development.


Agenmestencel-T (MSC_apceth_101)

apceth Biopharma’s lead product contains genetically engineered MSC for the treatment of advanced and recurrent solid cancers. MSC are isolated from the patient’s bone marrow, multiplied in cell cultures and genetically engineered with our proprietary vector.

Agenmestencel-T is the first cancer therapy based on genetically engineered MSC to be approved for clinical testing anywhere in the world.

The mode of action:
    Agenmestencel-T are genetically engineered MSC (gmMSC) with the inborn ability to target tumors and express the therapeutic transgene herpes simplex virus thymidine kinase (HSV-TK) under control of RANTES promoter in the tumor tissue.

CLINICAL TRIAL:
Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial with Modified Autologous MSC_apceth_101 (TREAT-ME 1)
Start:November 2013
Location:Munich, Großhadern University Hospital LMU
Current status: Phase I (safety) completed, phase II (efficacy) completed in 2016
Drug:Patients’ own, genetically engineered MSC
Trial design:Open-label, multi-center, phase I/II clinical trial
Indication:Advanced, recurrent or progressive gastrointestinal adenocarcinoma (gastric, colorectal, cholangiocellular and pancreatic carcinoma)
Primary objective:Safety and tolerability
Secondary objective: Efficacy (RECIST criteria)
Link clinical trial database: NCT02008539
Information and contact:contact@apceth.com


Alecmestencel-T (MSC-Apceth)

Alecmestencel-T is an autologous MSC therapy for the treatment of Peripheral Arterial Occlusive Disease (PAOD) with concomitant Critical Limb Ischemia (CLI).

Alecmestencel-T is a pure population of native MSC, isolated from the patient’s bone marrow, obtained by aspiration from the patient’s iliac crest. The MSC are isolated and expanded in cell cultures to generate a therapeutically effective cell dose.

The product completed a phase I/II clinical trial in 2014. The trial proved the excellent safety and tolerability of Alecmestencel-T. The results also generated the following hypothesis for a subsequent confirmatory clinical trial:

  • MSC-apceth infusion improves macrocirculation and microcirculation;
  • MSC-apceth infusion supports revascularization.
CLINICAL TRIAL:
Tolerability and efficacy of an intravenous infusion of autologous MSC_apceth for the Treatment of Critical Limb Ischemia
Start:2011
Location:Munich, Isar Clinical
Current status: Completed, results available
Drug:Patient's own (autologous) native MSC
Trial design:Open, randomized, mono-center, two-parallel group clinical phase I / II trial
Indication:Critical Limb Ischemia (CLI) in patients with Advanced Peripheral Arterial Occlusive Disease (PAOD) subsequent to percutaneous transluminal angioplasty
Primary objective:Safety and tolerability
Secondary objective: Efficacy
Link clinical trial database: NCT01351610
Information and contact:contact@apceth.com


Alecmestencel-L

Alecmestencel-L is apceth Biopharma’s first allogeneic MSC therapy for the treatment of transplantation-related conditions that require modulation (suppression) of the immune system.

The active component of Alecmestencel-L is MSC isolated from the bone marrow of a non-related donor.

As compassionate use therapy, Alecmestencel-L was used to treat critically ill patients suffering from life-threatening Graft-versus-Host Disease (GvHD), a severe complication after allogeneic hematopoietic stem cell or bone marrow transplantation, with a high mortality rate.