Date: 2014-10-15
Type of information: Interim results
phase: 1-2
Announcement: presentation of results at the 22nd Annual Congress of the European Society of Gene and Cell Therapy (ESGCT) being held in The Hague, Netherlands from October 23rd-26th, 2014
Company: Medgenics (USA-Israel)
Product: MDGN-201 (TARGTEPO™), formerly known as EPODURE™
Action mechanism:
Disease: anemia in dialysis patients with end-stage renal disease or chronic kidney disease
Therapeutic area: Renal diseases - Kidney diseases
Country:
Trial
details: The trial will enroll up to 18 patients with either CKD or ESRD who require erythropoietin treatment for anemia. Each patient will receive one or more BioPumps and will be followed for at least one year. The trial endpoints include plasma erythropoietin levels, blood counts and safety assessment. (NCT02117427)
Latest
news: * On October 15, 2014, 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 orphan diseases, released initial positive clinical data from the clinical study of MDGN-201. Three patients have been enrolled and implanted to date (3.5, 2.5, and 1.0 months post-implantation). Results indicate a sustained physiological secretion of eEPO, maintenance of hemoglobin in the targeted range without the need for rescue rHuEPO or transfusion. An abstract detailing these results has been accepted for presentation at the European Society for Gene and Cell Therapy meeting (ESGCT), October 23rd-26th in The Hague, Netherlands (See below). * On October 7, 2014, Medgenics announced that initial data from its ongoing Phase 1/2 clinical trial of MDGN-201 (Targtepo™), formerly known as Epodure™, will be presented at the 22nd Annual Congress of the European Society of Gene and Cell Therapy (ESGCT) being held in The Hague, Netherlands from October 23rd-26th, 2014. The presentation entitled "Prolonged Secretion of Physiological Levels of Autologous EPO by TARGT", will be presented by Dr. Garry Neil, Chief Scientific Officer. Dr. Neil will present data on the first three erythropoietin (EPO)-dependent patients from the ongoing clinical study of the Targtepo™ (Transduced Autologous Regenerative Gene Therapy) system in dialysis patients with anemia due to end-stage renal disease (ESRD) or chronic kidney disease (CKD). * On June 5, 2014, Medgenics announced that the first patient has been enrolled in its Phase 1/2 clinical trial of MDGN-201 (Epodure™). The aim of the trial is to validate the potential of BioPump™ platform using a second generation vector, which was developed to enhance durability of the proposed therapeutic effect. The study will evaluate the potential of the updated platform to offer sustained production and delivery of erythropoietin to treat anemia in dialysis patients with end-stage renal disease or chronic kidney disease.The trial will enroll up to 18 patients with either CKD or ESRD who require erythropoietin treatment for anemia. Preliminary results are expected by the end of 2014.
