December 7, 2003, Updated September 13, 2012

The Biopump uses a thin slice of genetically engineered skin to continuously produce and deliver therapeutic proteins.A remarkable new way to administer protein therapy is being tested on humans for the first time ever at Hadassah Medical Center in Jerusalem.

The BioPump, the name for the new protein therapy technology developed by the Israeli biotechnology company, Medgenics, is revolutionary because it relies on the patient’s body itself to internally administer the protein therapy needed to combat disease.

Medgenics announced the beginning of its Phase 1 clinical trials taking place at Hadassah for delivering Erythropoietin (EPO) in patients suffering from anemia.

The Biopump uses a thin slice of genetically engineered skin to continuously produce and deliver therapeutic proteins. The implant is being tested for the delivery of erythropoietin for people with chronic kidney disease who have anemia. Currently, people with the condition must have multiple injections.

UCLA professor of medicine Dr. Allen R. Nissenson, a consultant to Medgenics, said that the treatment allowed pieces of the patient’s skin to function as small drug factories.

The BioPump works by removing a small tissue sample from the patients skin. The tissue sample is then processed in a lab where the gene for the required protein is introduced. The cells of the excised tissue sample then begin to produce and secrete that protein. The amount of secreted protein can be adjusted according to the recommended therapeutic quantities. It is at this point that the tissue sample can be called a BioPump, for the skin sample has now become a micro-organ that secretes the desired amount of protein therapy all on its own.

The BioPump protein therapy is then re-implanted back under the patient’s skin where it continues to secrete the protein therapy for an extended amount of time until the grafted skin cells die. The company is working to automate this method, but at the moment this minimally invasive procedure still offers a remarkable alternative to the current protein delivery model, a highly expensive series of injections that risk complications and require repeated visits to the doctor. Though this trial is introducing EPO, the BioPump is designed to work for any number of protein therapies.

Two patients have already received a minimum dose Biopump that raised their level of erythropoietin with no reported adverse effects.

“Although these are clearly early results, they are encouraging as they are the first indication that Biopumps can deliver protein safely in humans,” says Medgenics founder and CEO Andrew Pearlman.

The phase one clinical trial is taking place in Israel with the goal of demonstrating the safety and efficacy of Biopumps. Besides erythropoietin, says Medgenics, the implants could be used for a wide range of proteins.

If successful, Medgenics would launch large human tests and seek Food and Drug Administration approval in 2006.

The Clinical Trial team is headed by Hadassah’s Prof. Eithan Galun, Dr. Itzhak Lippin and Medgenics’ VP Bioscience Dr. Noam Shani.

“The Biopump concept represents a technology shift from industrial protein production followed by multiple injections into a more natural medicine offering continuous production and delivery within the patient,” says Shani.

Nissenson added, “If the Biopump can deliver therapeutic levels of EPO in patients for many months, it potentially represents a major advancement in the safe, convenient treatment of anemia and could extend treatment to major, undertreated populations suffering from this common and devastating condition.”

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.”

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