BioElectroMed is developing a new medical device called the EndoPulse" that works in conjunction with an echoendoscope to deliver nanosecond pulsed electric field therapy to treat pancreatic carcinoma as well as lesions in the kidney and liver. The EndoPulse" is designed to penetrate through the stomach wall into a pancreatic carcinoma before extending an electrode array on both sides of the tumor. We are also developing a high voltage model of the PulseCure" nanosecond pulse generator that can generate 30 kV/cm between the two electrode arrays, exposing the entire tumor to this field strength. We have determined that the application of 500 pulses 100 ns long and 30 kV/cm in amplitude triggers apoptosis in all the human tumor cells between the electrodes and causes them to self-destruct within two weeks. We propose to complete the design and testing of both the EndoPulse" and PulseCure" prototypes and have the final versions manufactured under GMP for use in human clinical trials. These two instruments will then be used to ablate small regions of pancreas in pigs to demonstrate safety and efficacy prior to submitting the application to the FDA for an Investigational Device Exemption (IDE) required for the clinical trial. Once the IDE is granted, we will conduct a six-patient feasibility clinical trial at Stanford University Medical Center with Drs. Ann Chen and Subhas Banerjee acting as Co-Principal Investigators of this trial. These two gastroenterologists receive 3-4 patients per month with non-resectable pancreatic carcinomas for which there is currently no effective therapy. If the PulseCure"-EndoPulse" system can reliably ablate pancreatic carcinomas, it would offer the first effective, non-surgical therapy for pancreatic cancer that could extend the lives of tens of thousands of patients each year.

Public Health Relevance

This research will develop a breakthrough, minimally invasive approach to the treatment of pancreatic tumors for which current treatment options are poor and costly. This new medical device called the EndoPulse is readily extendable to treat other focal internal lesions especially in the liver, kidney and lymph nodes. The EndoPulse is guided to the internal tumor by ultrasound imaging in an echoendoscope and applies ultrashort electrical pulses that cause the tumor cells to self-destruct.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44CA150484-02
Application #
8252023
Study Section
Special Emphasis Panel (ZRG1-OTC-R (11))
Program Officer
Haim, Todd E
Project Start
2012-09-01
Project End
2014-08-31
Budget Start
2012-09-01
Budget End
2013-08-31
Support Year
2
Fiscal Year
2012
Total Cost
$1,019,109
Indirect Cost
Name
Bioelectromed Corporation
Department
Type
DUNS #
064678464
City
Burlingame
State
CA
Country
United States
Zip Code
94010
Nuccitelli, Richard; Wood, Ryan; Kreis, Mark et al. (2014) First-in-human trial of nanoelectroablation therapy for basal cell carcinoma: proof of method. Exp Dermatol 23:135-7
Nuccitelli, Richard; Huynh, Joanne; Lui, Kaying et al. (2013) Nanoelectroablation of human pancreatic carcinoma in a murine xenograft model without recurrence. Int J Cancer 132:1933-9
Nuccitelli, Richard; Lui, Kaying; Kreis, Mark et al. (2013) Nanosecond pulsed electric field stimulation of reactive oxygen species in human pancreatic cancer cells is Ca(2+)-dependent. Biochem Biophys Res Commun 435:580-5