Medgenics gets OK to start Phase IIa trial of their EPODURE biopump...

Article posted 3/23/12 on Proactive Investors.com. Israel-based Medgenics gets Israeli Ministry of Health OK to being a Phase IIa trial of it's EPODURE biopump to treat HCV, anemia & haemophilia. The technology will allow patients to continuously produce and maintain their own proteins without dangerous variations in PK.   


Medgenics gets approval to begin Phase IIa clinical study on EPODURE biopump

Fri 11:17 am by Giles Gwinnett

Medgenics has received the green light to begin a Phase IIa clinical study on its EPODURE which is used to treat anaemia.

The company has received clearance from the Israeli Ministry of Health to begin the study, it said.

The firm's biopump system sees a tiny sliver of the patient's tissue taken and modified to carry the gene to enable it to continuously produce the required protein to treat the condition.

It is is developing three applications of the technology - to treat anaemia, hepatitis-C and haemophilia.

The study, announced today, will involve 20 patients and will asess EPODURE's ability to replace months of routine injections for anaemic patients who have end-stage renal failure - or kidney disease.

Each patient will receive an individually targeted initial dose of EPODURE biopumps designed to produce levels of the protein that would replace the routine injections over a period of 4-12 months.

President and CEO of the firm Andrew Pearlman said he expected the phase IIa study to build on the positive clinical results from the earlier Phase I/II study of EPODURE to treat pre-dialysis patients with chronic kidney disease.

"This is the first clinical study that will permit adjustment of the EPODURE dose based on patients' needs as is currently done in standard EPO (erythropoietin) treatment, and will be standard in future EPODURE use.

"This represents a significant change from the fixed-dose study we previously conducted in pre-dialysis patients," he said.

Dr Pearlman added that the company's EPODURE Biopump technology offered potential advantages over current therapy because it enabled patients to continuously produce and deliver their own proteins.

"Sustained delivery of EPO is expected to help keep hemoglobin within the target range to reduce the risks of hemoglobin variability, while avoiding the possible risks posed by EPO concentrations many times the normal physiological range, as observed with EPO administrations.

"EPODURE could potentially be a safer anemia management tool. Additionally, the cost benefits for the management of anemia could be highly significant," he said.