Apceth GmbH 's Ground-Breaking First-In-Man, First-In-Class Clinical Trial In Oncology With Genetically Modified Mesenchymal Stem Cells Is Now Enrolling
1/23/2014 10:36:54 AM
Munich, Germany, January 23, 2014 / B3C newswire / - As a world first, apceth announced today 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).
This innovative 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 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. This unique principle is also applicable to other cancer types. apceth intends to advance this treatment to an off-the-shelf product where cells obtained for healthy donors will be used to treat multiple patients.
“This is an important milestone for all of us at apceth who strive to produce truly innovative products that make a real difference to patients” said apceth’s CEO, Dr Christine Guenther. “We are the first to use next-generation MSC-based therapies in the clinic and this sets us apart from the competition. This is a platform technology that carries significant potential and represents the future of cell therapies”.
apceth is a leading European pioneer in the development, GMP manufacturing and clinical implementation of innovative (stem) cell-based therapies, for the treatment of life threatening diseases. It combines the principles of stem cell biology with groundbreaking technologies, applying the highest standards for GMP manufacturing, safety regulations and quality control according to the European Regulation for “Advanced Therapy Medicinal Products” (ATMPs). The company was founded in 2007 and is privately owned by its founders and private investors.
apceth is pleased to offer GMP contract manufacturing services for ATMPs, to pharma and biopharmaceutical partners.
Dr. Christine Günther, CEO
Prof. Dr. Ralf Huss, CSO
apceth GmbH & Co. KG
D-81377 Munich, Germany
Phone: +49 (0)89-7009 608-0
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