Patients with GI Cancer
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Role of ePORE® therapy in Gastrointestinal cancers

The role of pulsed electrical fields or electroporation, generated by the ePORE® which increases the cell membrane porosity of gastrointestinal cancers has been extensively researched and published on. A specially designed device, the EndoVE® , has been developed to enable the safe and effective application of pulses to GI cancers with a number of successful clinical studies now completed. 

Currently the use of ePORE® therapy in the GI cancer setting with EndoVE® is applied for the palliation of symptoms (bleeding cessation, pain relief, decreasing tumour volume).

A number of studies are currently ongoing to explore a wider application to include earlier stage disease and to explore the intratumoral immune response generated after ePORE® therapy. For information on ongoing clinical studies with the EndoVE® please email info@mirai-medical.com.

Our EndoVE® probe attaches to a standard gastroscope or colonoscope and delivers pulsed electrical fields generated by the ePORE®  to the tumour cells, allowing an injected drug to passively diffuse far more effectively into the cancer cells and kill them.

The vacuum feature in the endoscopic electrode assists in drawing tumour tissue into direct contact with the electrodes contained within the EndoVE® device.  There is minimal discomfort associated with the procedure, and reduction in the size of the tumour can be achieved in just one session. Additionally, treatment with EndoVE® has been shown to aid in achieving a reduction in bleeding, which can be a symptom of many GI cancers. Overall EndoVE® has been shown to decrease symptoms and improve patients’ quality of life.

ePORE® therapy Procedure for GI Cancers

The treatment is delivered with the patient receiving the appropriate endoscopy anaesthesia. The chemotherapeutic drug or calcium solution being combined with the electroporation treatment is administered. The patient is treated under normal endoscopy/colonoscopy sedation. The EndoVE® probe, is attached to the endoscope and positioned in close proximity to the tumour tissue by the clinician. If necessary, a vacuum is used to draw the tumour tissue into contact with electrodes. The pulsed electrical fields are then delivered in a matter of seconds by the ePORE® . Tumour tissue within the vicinity of the pulsed electrical fields become significantly more porous allowing the uptake of drug far more efficiently and inducing tumour cell death. Healthy tissue in the margins remains largely unaffected by the procedure due to conductivity differences between healthy and tumour tissue in addition to the greater ability for healthy cells to recover quickly from the stress of the pulsed electrical fields.

Clinical Progress

‘Electrochemotherapy for colorectal cancer using endoscopic electroporation: a phase 1 clinical study’ (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6976320/)

‘Endoscopic electrochemotherapy for esophageal cancer: a phase I clinical study’ (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5979192/)

PIONEER Registry – A database of all the existing and current patients being treated with ePORE therapy.

General Q&A

ePORE® therapy with EndoVE® can be used for the treatment of gastrointestinal cancers including oesophageal, colorectal, gastric and rectal cancer.

ePORE® therapy can be repeated as necessary, to improve the response to the treatment as felt appropriate by the clinical team managing the case.

Yes, ePORE® therapy delivers high frequency pulsed electrical fields which can be administered to GI cancers directly with the EndoVE® device. A procedure may be carried out under light sedation or under certain circumstances may require general anaesthesia and this will be determined by the clinical team.

Patients are usually treated as a day case, however, this must be assessed on a patient-by-patient basis and in some cases, it may be more appropriate to keep the patient under surveillance for the night after the operation.

Some patients may experience a mild fever following the treatment, but pain-relieving medication can be prescribed to relieve this.

 Serious side effects are extremely rare and will be explained by the clinical team responsible for your care.

This is determined by the stage of the disease and how far advanced it is at the time of treatment. Typically early stage disease is managed with local surgery with more advanced disease treated using a combination of surgery, chemotherapy and radiotherapy. 

ePORE® therapy delivered with EndoVE® is currently utilised for later stage disease in patients considered unsuitable for surgery with the goal of controlling symptoms and improving patient’s overall quality of life.

Research and clinical studies in managing GI cancers with EndoVE® in combination with calcium are ongoing in earlier stage disease.

ePORE® therapy aids in stopping or reducing bleeding caused by GI cancers by immediately inducing vasoconstriction of the capillaries supplying blood flow to the tumour. Additionally, ePORE® therapy results in long-term disruption of the cytoskeletal structure of the tumour cells, and also causes the barrier function of the microvascular endothelium to be compromised. Tumour cells are consequently exposed to a lack of oxygen and nutrients due to the disruption in blood flow to the tumour and facilitates inducing their  death.

ePORE® therapy is a localised precision treatment and is typically delivered alone. The clinical team will consider all the available suitable options for care and will advise on the best approach to take. 

If a patient has a pacemaker, then treatment should not be delivered in areas that are in close proximity to the pacemaker. Please advise the clinical team if you have a pacemaker and require treatment with ePORE® 

Very low concentrations of bleomycin are used and maintain their effectiveness due to the increased porosity of the tumour cells, thereby allowing maximum absorption of a low dose chemotherapeutic drug. If bleomycin is injected intravenously, the dose provided is 15,000 IU/m2. If injected intratumorally,  it is delivered at a concentration of 1000 IU/ml with the total dosage determined by the volume of the tumour. Please refer to the reference section for further information.

Very few side effects associated with the use of bleomycin in combination with pulsed electrical fields have been observed  as the doses used are significantly lower than the standard doses deployed during conventional chemotherapy treatment. Please refer to the reference section for further information.

The published evidence demonstrates that pulsed electrical fields, tissue electroporation, is effective in a wide range of solid tumour histology subtypes.  Typically, bleomycin when delivered alone is used in only a small number of cancer types however when administered in combination with pulsed electrical fields its effectiveness is greatly expanded. Bleomycin works by binding with DNA and breaking its structure which forces the cell into a cell death pathway. Very few molecules of bleomycin are required to trigger cell death however normally its ability to enter a cell is limited due to the large size of the bleomycin molecule and its inability to cross the cell membrane.  ePORE® therapy overcomes this barrier and enables highly effective localised tumour cell death without toxicity to healthy tissue structures. Please refer to the reference section for further information.