Irreversible Electroporation

Guest Editor: Boris Rubinsky, Ph.D.

Irreversible Electroporation in Medicine (p. 255-260)

Abstract

This is a brief introduction to the emerging field of irreversible electroporation in medicine. Certain electrical fields when applied across a cell can have as a sole effect the permeabilization of the cell membrane, presumable through the formation of nanoscale defects in the cell membrane. Sometimes this process leads to cell death, primarily when the electrical fields cause permanent permeabilization of the membrane and the consequent loss of cell homeostasis, in a process known as irreversible electroporation. This is an unusual mode of cell death that is not understood yet. While the phenomenon of irreversible electroporation may have been known for centuries it has become only recently rigorously considered in medicine for various applications of tissue ablation. A brief historical perspective of irreversible electroporation is presented and recent studies in the field are discussed.

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AngioDynamics (NASDAQ:ANGO) reported that the first human clinical use employing irreversible electroporation (IRE) to ablate soft tissue was completely successful based on analysis of biopsies performed on five patients two weeks after their treatment.

The IRE treatment was conducted during the first week of April, 2008 as part of a pilot trial focused on determining the success of treating soft tissue with IRE. Biopsies taken from the treated patients prostates were normal and the patients had no side effects. The trial is expected to continue to develop clinical data on the technology's therapeutic effectiveness.

"We are very pleased with the first clinical results achieved in human use," commented Dr. Gary Onik MD, President of Oncobionic Inc. and Director of Surgical Imaging at Celebration Health Florida Hospital. "This confirms our belief in the value of the technology and its promise to become the next generation of ablation technology."

IRE is a non-thermal tissue ablation technique in which electrical fields are used to create nano-scale defects in a cell's membrane, which causes cell death only in the targeted tissue, without destroying critical structures such as ducts, blood vessels and nerves. A research team headed by Boris Rubinsky, Distinguished Professor of Bioengineering at the University of California, Berkeley, invented the IRE technology used in this trial. The technology is exclusively licensed by the University of California to Oncobionic, Inc. for commercial development.

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In October 2006, AngioDynamics announced that it had reached an agreement with Oncobionic to acquire the company, and that the acquisition would be completed upon the first four consecutive cases of successful treatment of soft tissue in humans. In November 2006, the U.S. Food and Drug Administration cleared the IRE technology for human use for the indication of soft tissue ablation.

Under a share purchase agreement dated October 12, 2006, AngioDynamics agreed to pay a total purchase price of $25 million, less Oncobionic's long-term debt as of the closing date of the acquisition. $5 million of the purchase price was paid at the execution of the purchase agreement. The results reported today will trigger the second installment of approximately $10 million upon the closing of the acquisition, which is expected to be completed in May 2008. In addition, approximately $5 million is payable six months after the closing date and the remaining balance of approximately $5 million is payable 18 months after the closing date.

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Comments by Don Cooley

Note the three parts of the above in bold type.  It is always suspect to see this chain of events when the person who did the study has a monetary gain on the successful competition of a study.  The study was of four patients who had prostate cancer.  I do not know the diagnosis of the four men as to their Gleason, PSA, Stage, etc. but would assume they were patients with a low grade cancer.  Which then brings up a question as to whether they should be treated at all.  It is too small and very much too soon to have any definitive results.  On other methods of treatment of prostate cancer we look for long term results of 5 to 10 years.  This procedure is highly experimental but will be pushed and sold as a new wondrous easy treatment.  At this point I would say BEWARE.

With the above out of the way and understanding we have really no results on the human trials outside of those who will profit from it let me give you my short take on the treatment.

I believe the treatment to be highly experimental as I said above and one that I would not recommend at this time.  With that said there is some very interesting research on this in other diseases.  It looks like it has some hope to the treatment of prostate cancer.  It should not be a treatment done easily by your local Urologist as it required a great understanding of electricity, the treatment itself and the pre treatment planning.  The insertion of 2 to 6 electrodes into the gland has to be planned to cover the area they want treated.  This has to be carefully pre planned to be the most effective.  There seems to be little to no damage to the surrounding tissue but one would not want to miss any part of the gland because prostate cancer is multi-focal that is - it has many small foci of tumor in the gland - many of which could never be seen with the imaging we have available. 

If it is there thinking to treat only what they can see than they will miss some of the tumors.  Of course as those missed tumors grow the patient could be treated again and again.  But in the meantime I would worry about the spread of the disease to other parts of the body.

Not much information available but I would proceed with a great deal of caution.  I would not want to recommend this treatment, even as promising as it looks, to anyone at this time.  Since the name of the procedure is strange I would expect the promoters to come up with some catchy phrase to use in the selling of the treatment.

Here are three PDF files that will give you additional information on the treatment.

Irreversible Electroporation, Guest Editor: Boris Rubinsky, Ph.D.

Tumor ablation with irreversible electroporation. A-Sakere B, et al,

Irreversible electroporation: implications for prostate ablation. Onik, et al,