Medgenics, Inc. has announced the preliminary data from its ongoing Phase IIa clinical trial in Israel with EPODURE Biopumps to treat anemia in patients on dialysis with end-stage renal disease, or ESRD, by sustained delivery of erythropoietin, or EPO.
As the first study with EPODURE Biopumps in ESRD patients, the Phase IIa study is testing administration techniques and dosing to determine if EPODURE can replace most or all of the injections of EPO or other erythropoietic stimulating agents (ESAs) currently used in the standard care of such patients, while maintaining blood hemoglobin levels within the desired range.
The current standard of care involves frequent EPO or ESA injections, which require patient compliance for reliable administration. Each injection is short-lived, typically causing an extreme transient elevation of EPO in the patient's blood, followed by a decline to ineffective levels within a few days, so the patient may not have sufficient EPO or ESA until the next injection. The high transient levels of EPO in the blood are a source of potential safety concern to many medical experts as well as to the FDA.
Consistent with the earlier Phase I/II study with EPODURE in pre-dialysis patients, the EPODURE procedure went well in these first dialysis patients. These patients will continue to be monitored and enrollment in the study is continuing.
Medgenics' EPODURE Biopumps aim to provide a way to maintain hemoglobin within a target physiological range for anemic patients through the sustained delivery of EPO, while avoiding the extreme elevations seen with injections. Medgenics believes that this steady delivery could improve the safety and efficacy of anemia treatments while enhancing patient quality of life by providing reliable treatment that reduces or eliminates the need for frequent EPO or ESA injections, and also provides cost benefits to payers.
"We believe that this Phase IIa study will provide valuable insight into the use of EPODURE to treat anemia in patients on dialysis, which is the largest segment of the anemia market. Although the findings presented at Kidney Week 2012 are on only three patients, we are thus far encouraged by this ongoing study. Full study results can be supportive of the larger Phase II study in dialysis patients in the US, now slated to begin in the first half of 2013. Once completed, we believe these studies will provide data to support the use of EPODURE in the treatment of anemia from chronic kidney disease," stated Andrew Pearlman, President and CEO of Medgenics.