Date: 2015-07-15
Type of information: Recruitment of the first patient
phase: 2
Announcement: recruitment of the first patient
Company: Medgenics (USA - Israel)
Product: MDGN-201 (TARGTEPO™), formerly known as EPODURE™
Action
mechanism: gene therapy. The TARGT™ (Transduced Autologous Restorative Gene Therapy) is an ex vivo gene therapy platform that provides autologous, continuous protein or peptide therapy in the physiological range. The system consists of several 2 x 30 mm pieces of dermal tissue (MicroOrgan, MO), extracted under local anesthetic in which its fibroblasts cells are transduced with a viral vector containing a gene of interest. TARGTEPO refers to a TARGT that provides erythropoietin (EPO).
Disease: anemia of end stage renal disease
Therapeutic area: Kidney diseases - Renal diseases
Country: USA
Trial
details: The MG-EP-RF-04 trial is a phase 2, open-label study. The objective of this study is to evaluate the safety and biologic activity of MDGN-201 TARGTEPO treatment when maintaining hemoglobin levels within the targeted range of 9-12 g/dl. Biological activity assessments will include duration of TARGTEPO secretion as measured by serum EPO levels above baseline. Each patient will be administered with a targeted dose of EPO delivered via TARGTEPO. The targeted doses will be determined according to two cohorts as follows: Group A (18-25 IU/Kg/day), Group B (35-45 IU/Kg/day). (NCT02468414)
Latest
news: * On July 15, 2015, Medgenics, the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, announced that the first patient has been enrolled in its U.S.-based Phase 2 clinical trial of MDGN-201 (TARGTEPO™), an investigational gene therapy for the treatment of anemia in end stage renal disease (ESRD) patients undergoing peritoneal dialysis.
