Clinical Trials - Overview
Endoscopic Electroporation with the EndoVE® system has been studied in a rigorous, stepwise manner beginning with in-vitro validation work through to animal studies, followed by a phase I clinical trial on patients with inoperable colorectal cancer. The EndoVE® system allows for the endoscopic treatment of gastrointestinal tumours. It may be used to target colorectal, gastric and oesophageal cancers by applying a brief electric pulse to the tumour. This greatly enhances tissue permeability maximizing the local/tumour absorption of chemotherapy drugs. As delivery is targeted, there is a reduction of over 90% of the chemotherapy drug (bleomycin or cisplatin) required, resulting in significant benefits for patients including ease of treatment and minimal side effects.
Absorption occurs only in the area that has been treated with the electrical field and therefore is targeted to the tumour, leaving surrounding healthy tissues unaffected. One of the significant advantages of the system is that healthy cells and tissues surrounding the tumour are selectively less sensitive than the cancer cells to the treatment. A small percentage of healthy cells may undergo programmed cell death / apoptosis but a significant inflammatory reaction is not induced.
This approach to cancer treatment has become established in the treatment of skin cancers and is referred to as electrochemotherapy. The application of short, intense square wave pulses of direct current to skin tumors has been demonstrated to result in up to a 10-fold log increase in the intracellular concentration of bleomycin. Systemic toxicity and collateral injury is minimal as cytotoxicity is restricted to the tissues covered by the applied electrical field. Because the resulting cell death is by apoptosis there is minimal inflammatory reaction or systemic illness during involution of the tumour.
Clinical experience to date has been largely related to cutaneous malignancies, often recurrent and metastatic after multimodal therapies. The treatment is minimally disturbing for patients, is easy to perform in an outpatient setting and is inexpensive. The real potential for this treatment however exists through facilitating a minimally invasive approach to tumour resolution and this has consequently led to the development of the EndoVE®. The endoscopic system was designed to facilitate the treatment of internal cancers and a significant amount of preclinical large animal data has been conducted which demonstrates a significant opportunity for patient care. Canine cases referred to the veterinary clinic and diagnosed with colorectal or gastric cancers have been treated using the EndoVE® with excellent results achieved.
The treatment of spontaneous canine colorectal cancers has demonstrated the EndoVe® device to be effective and safe with complete tumour resolution noted in the cases (7) treated to date. All procedures were conducted as a simple colonoscopy type procedure with no adverse side effects recorded.
A clinical trial for patients with inoperable colorectal cancer with the EndoVE® system is underway and it is planned to expand to colon, stomach and esophageal over the next 24 months.
Details on the current colorectal cancer clinical trial cancer be accessed here http://clinicaltrials.gov/ct2/show/NCT01172860. Patients are treated under sedation on an outpatient basis.