Medgenics ($MDGN) confirmed plans to advance clinical testing of its Epodure biopump sustained release treatment for chronic kidney disease, following positive results from a Phase I/II trial.
The company, based in Israel and San Francisco, said in a release that the firm, based on the positive results, will file an Investigational New Drug Application with the FDA geared toward a Phase IIb clinical trial of Epodure by mid-2012.
"We are very encouraged by these positive data," Medgenics president and CEO Andrew Pearlman said.
The biopump continuously produces and delivers therapeutic proteins using a patient's own skin biopsy to generate the treatment. If successful, the technology would help reduce the risk of hemoglobin variability in patients and make anemia management easier and more cost-effective, the company believes.
Medgenics released details of the trial results during a poster presentation at the American Society of Nephrology's Kidney Week 2011, held Nov. 8-13 in Philadelphia. Researchers highlighted results from 13 anemic chronic kidney disease patients in an open-label, dose-ranging study who were treated 6-30 months with two levels of Epodure implanted dosing. They found that the procedure was well tolerated and the body did not reject the treatment--which also turned out to be long-lasting.
Healthy patients produce the hormone erythropoietin, or EPO, to stimulate bone marrow to make enough red blood cells that in turn give vital organs enough oxygen to function, the National Institute of Health notes. But there is a shortage of EPO in anemia patients. Medgenics set out to prove it could provide over six months of sustained EPO dosing delivery from a single Epodure treatment. The clinical trial involved taking small biopsies from a patient's skin, using a local anesthetic, and then converting them in days into biopump EPO production units. This happens by injecting EPO genes into cells of the biopsies.
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