PHILADELPHIA, PA, USA I July 15, 2015 I Medgenics, Inc. (MDGN), 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, today announced that the first patient has been enrolled in its U.S.-based Phase 2 clinical trial of MDGN-201 (TARGTEPOTM), an investigational gene therapy for the treatment of anemia in end stage renal disease (ESRD) patients undergoing peritoneal dialysis.
“Enrolling our first patient in the U.S. represents a significant achievement for the Company,” commented Garry Neil, MD, Chief Scientific Officer of Medgenics. “We look forward to progressing the study and continuing the advancement of this unique gene therapy platform.”
About the Trial (MG-EP-RF-04)
The objective of this Phase 2, open-label 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). Additional details may be found on www.clinicaltrials.gov using identifier NCT02468414.
About Medgenics, Inc.
Medgenics is developing the TARGT(TM) (Transduced Autologous Restorative Gene Therapy) system, a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides using ex vivo gene therapy and the patient’s own tissue for the treatment of orphan and rare diseases. For more information, visit the Company’s website at www.medgenics.com.
SOURCE: Medgenics
Post Views: 196
PHILADELPHIA, PA, USA I July 15, 2015 I Medgenics, Inc. (MDGN), 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, today announced that the first patient has been enrolled in its U.S.-based Phase 2 clinical trial of MDGN-201 (TARGTEPOTM), an investigational gene therapy for the treatment of anemia in end stage renal disease (ESRD) patients undergoing peritoneal dialysis.
“Enrolling our first patient in the U.S. represents a significant achievement for the Company,” commented Garry Neil, MD, Chief Scientific Officer of Medgenics. “We look forward to progressing the study and continuing the advancement of this unique gene therapy platform.”
About the Trial (MG-EP-RF-04)
The objective of this Phase 2, open-label 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). Additional details may be found on www.clinicaltrials.gov using identifier NCT02468414.
About Medgenics, Inc.
Medgenics is developing the TARGT(TM) (Transduced Autologous Restorative Gene Therapy) system, a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides using ex vivo gene therapy and the patient’s own tissue for the treatment of orphan and rare diseases. For more information, visit the Company’s website at www.medgenics.com.
SOURCE: Medgenics
Post Views: 196
