Medgenics, an Israel biotechnology company, launched its Phase I clinical trial of its Biopump technology for delivery of Erythropoietin (EPO) in Chronic Kidney Disease (CKD) patients suffering from anemia. The Biopump – Medgenic’s unique, patented platform protein therapy technology – uses tissue and genetic engineering on a thin excised sample of the patient’s skin to provide continuous production and delivery of a desired therapeutic protein directly in the patient. ISRAEL21c placed a report on this biotech innovation in the Los Angeles Times in a roundup of anemia drugs.

Here is the story that ran in the Los Angeles Times.

Roche Steps Up Competition in Anemia Drugs

By Denise Gellene, Times Staff Writer

SAN DIEGO – What is now a contest between Amgen Inc. and Johnson & Johnson over the lucrative anemia drug business could soon become a three-way race.

At a medical meeting here this weekend, Swiss drug maker Roche said it was ready to begin the final round of human tests needed for government approval of Cera, its investigational anemia drug. Cera appears to be able to last at least three times as long as Amgen’s Aranesp, according to Roche- an improvement that would mean fewer shots and office visits for patients…

… Also at the medical meeting Saturday, Medgenics Corp., an Israeli company backed by Silicon Valley venture funds, reported on an experimental gene therapy treatment that would make shots unnecessary.

UCLA professor of medicine Dr. Allen R. Nissenson, a consultant to Medgenics, said the treatment allowed pieces of the patient’s skin to function as small drug factories. First, a 1-inch-square piece of the patient’s skin is removed and then a virus is used to insert the erythropoietin gene into the skin cells. After about a week, with the virus fully removed, the skin is grafted to the patient’s arm or leg, where it should pump out the hormone for several months, until the grafted skin cells die.

Nissenson said a clinical trial of less than a dozen patients is underway in Israel and should be completed in three months. If successful, Medgenics would launch large human tests and seek Food and Drug Administration approval in 2006.

Medgenics plans to market the therapy to kidney doctors as an economic alternative to current anemia drugs, Nissenson said. “They are trying to position this as something that will save a lot of money. Medicare already spends $1 billion on EPO. The pricing on this will be cost effective.”