Medgenics has announced early data from its phase II clinical trial with the EPODURE biopump device. This trial used the company’s proprietary biopump to deliver the drug erythropoietin, or EPO, to anemic patients with chronic kidney disease who had not yet begun dialysis.
The company, based in Karmiel, Israel, has produced biopump applications for treating several chronic diseases, including hepatitis C, and is in the early stages of developing a biopump application that would treat hemophilia.
The biopump allows patients to produce, in their bodies on a long-term basis, their own natural human protein therapy. Cells are taken from patients, treated, placed in the biopump, and then the sterilized pump is implanted.
The recent trial results showed that the EPODURE pump produced an environment that let hemoglobin remain in a desired range for 2 to 4 months without any additional injections. The company noted that that the treatment never went past the typical normal range for hemoglobin.
The company plans a larger phase II trial for later this year, according to the firm’s website.
“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,” said Medgenics chief executive Andrew Pearlman. He added that the system “could provide clear cost benefits to payers.”
In recent years EPO drugs have been in the news for several reasons, including investigations into dialysis provider DaVita for overuse of the drug Epogen (made by Amgen), and double billing the government for drug that is left in vials and reused, according to a July 2012 Denver Post story. DaVita agreed to pay $55 million to settle over allegations of drug overuse; the company denied any wrongdoing.
Amgen also has settled suits, entering a guilty plea at the U.S. District Court in Brooklyn for misbranding its anemia drug, Aranesp, which meant that the company was accused of selling it for uses not approved by the FDA.
