Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Medgenics has started patient enrollment in its US-based Phase II clinical trial of MDGN-201 (TARGTEPO), an investigational gene therapy to treat anemia in end stage renal disease (ESRD) patients undergoing peritoneal dialysis.
Subscribe to our email newsletter
The company develops 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.
The open-label Phase II trial is designed to evaluate the safety and biologic activity of MDGN-201 TARGTEPO treatment when maintaining hemoglobin levels within the targeted range of 9-12g/dl.
Medgenics chief scientific officer Garry Neil said: "Enrolling our first patient in the U.S. represents a significant achievement for the Company.
"We look forward to progressing the study and continuing the advancement of this unique gene therapy platform."
The company said that biological activity assessments will include duration of TARGTEPO secretion as measured by serum EPO levels above baseline.
During the trial, each patient will be administered with a targeted dose of EPO delivered via TARGTEPO.
The targeted doses will be determined according to two groups as follows: Group A (18-25IU/Kg/day) and Group B (35-45IU/Kg/day).