Medgenics ($MDGN) has begun a Phase IIa trial of its Epodure Biopump, delivering sustained-release EPO (erythropoietin) in dialysis patients with end-stage renal disease. This trial, taking place in Israel after approval from the Ministry of Health, has treated two people to date, who have responded well, and is the first evaluation of the company's technology as an anemia treatment in this patient group.
EPO treats anemia by increasing patients' production of red blood cells. The study will enroll up to 20 patients and will see whether the delivery system could replace most or all injections of EPO or other erythropoietic stimulating agents (ESAs), which patients could need to take as frequent injections for many years. As well as being inconvenient, individual injections can lead to potentially harmful fluctuations of EPO levels in the blood.
The Epodure Biopump uses a sliver of the patient's skin tissue, which is genetically engineered to produce EPO and then re-implanted. Because the delivery of the EPO from the Epodure Biopump is constant, this would rule out fluctuations, and could also be more cost-effective. Previous studies looked at the Epodure Biopump in pre-dialysis patients with chronic kidney disease and found that a single administration raised or maintained hemoglobin for 6-36 months without the need for EPO or ESA injections.
"Our planned Phase II studies will provide valuable insight into extending the use of Epodure from treating anemia in pre-dialysis patients to treating the anemia of dialysis patients–the largest segment of the anemia market," stated Andrew Pearlman, president and CEO of Medgenics. The next step will be to launch a Phase IIb study in dialysis patients in the U.S. before the end of this year.
- read the press release