Medgenics Ltd. (AIM:MEDG; AMEX: MDGN) today reported interim results from the first four patients treated in its ongoing Phase IIa clinical trial in Israel of EPODURE Biopumps to treat anemia in patients on dialysis with end-stage renal disease (ESRD).
Biopump is a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue.
The four patients in the trial had been receiving routine EPO injections with each dialysis session until their EPODURE Biopumps were administered by subcutaneous implantation. Initial and on-going experience to date in ESRD patients is in line with observations from the Company’s prior Phase I/II study in anemic pre-dialysis patients with chronic kidney disease (CKD).
To date, Medgenics reported that there have not been any procedure or drug related serious adverse events. Each patient has received a single administration of EPODURE Biopumps, measured to produce between 19 to 51 IU EPO per kilogram per day, in place of the serial injections of EPO or ESA the patient had been receiving with each dialysis session. Following the administration of EPODURE Biopumps, the hemoglobin in these patients remained in the desired 9-11 g/dl range for 2-4 months, without needing any EPO or other ESA injections. Notably, at no point following EPODURE treatment did the concentration of EPO in the serum of the patients exceed the typical normal range and always remained under 100 mU/ml.
As the first study with EPODURE Biopumps in ESRD patients on dialysis, this Phase IIa study is testing administration techniques and dosing to determine how long a single treatment using EPODURE Biopumps can replace the periodic injections of EPO or other erythropoietic stimulating agents (ESAs) that are currently used in the standard care of such patients, while maintaining the patient’s hemoglobin within the desired range
Medgenics CEO and president Andrew Pearlman said, “These preliminary data are encouraging and we believe they will be valuable as we move forward with plans to implement a larger Phase II trial in the US in the second half of 2013. When EPODURE reaches routine clinical use, we believe the ability to titrate the dose to reach the most effective dosing level based on the patient’s early hemoglobin response could further extend the duration of hemoglobin maintenance."
He added, “EPODURE Biopumps aim to provide a cost-effective way to maintain hemoglobin within a target range in anemic patients by providing sustained delivery of EPO within the normal physiological range, while avoiding the extreme elevations seen with repeat injections. We believe that EPODURE could improve the safety and efficacy of anemia treatments while enhancing patient quality of life by providing a more reliable treatment that reduces or eliminates the need for frequent EPO or ESA injections, and also could provide clear cost benefits to payers."
Published by Globes [online], Israel business news - www.globes-online.com - on April 25, 2013
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