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Apparatus for electroporation mediated delivery for drugs and genes

An electroporation and electrode technology, applied in the field of cell perforation therapy or electrochemotherapy, which can solve the problem of difficulty in placing electrodes, such as distance

Inactive Publication Date: 2006-05-10
GENETRONICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When treating large or internal tumors, it can be difficult to place electrodes properly and measure the distance between them

Method used

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  • Apparatus for electroporation mediated delivery for drugs and genes
  • Apparatus for electroporation mediated delivery for drugs and genes
  • Apparatus for electroporation mediated delivery for drugs and genes

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0111] Example 1 - Using EPT to treat tumors in vivo

[0112] A course of treatment consists of the following steps: injecting bleomycin (0.5 units in 0.15 ml of saline) into the tumor using the fan-shaped approach described herein and, 10 minutes later, using needle array electrodes as described in this application Six square-wave electrical pulses were applied, and the electrodes were placed along a circle with a diameter of 1 cm. Needle arrays with variable diameters (eg, 0.5 cm, 0.75 cm, and 1.5 cm) were also used to accommodate tumors of different sizes. Stops of varying heights can be inserted into the center of the array so that the depth of penetration of the needles into the tumor can be varied. There is a built-in mechanism that switches the electrodes to maximize tumor coverage with the pulsed field. The electrical parameters are: central electric field strength of 780 V / cm, 6 x 99 microsecond pulses at 1 second intervals.

[0113] The results showed severe necro...

Embodiment 2

[0145] Example 2--Clinical trials for basal cell carcinoma and melanoma

[0146] At the end of 8 weeks, the same tumor response criteria as in Example 1 were used to evaluate the curative effect of bleomycin-EPT on tumors.

[0147] The concentration of bleomycin given was 5U / 1ml. The dosage of bleomycin is as follows:

[0148] tumor size

Dosage of bleomycin

3

0.5U

100-150mm 3

.75U

150-500mm 3

1.0U

500-1000mm 3

1.5U

1000-2000mm 3

2.0U

2000-3000mm 3

2.5U

3000-4000mm 3

3.0U

≥5000mm 3

4.0U

[0149] Table 5 below shows the results of response to treatment

[0150] NE = Not effective; less than 50% reduction in tumor volume.

[0151] PR = partial response; reduction in tumor volume equal to or greater than 50%.

[0152] CR = Complete Response; tumor disappearance as determined by physical examination and / or biopsy.

Embodiment 3

[0153] Example 3--Treatment of head and neck cancer with EPT

[0154] All patients below were treated with intratumoral injection of bleomycin using a needle array of 6 needles of different diameters. The voltage was set to achieve a nominal electric field strength of 1300 V / cm (multiply the diameter of the needle array by 1300 to give the set voltage of the generator.) The length of the pulse was 100 microseconds.

[0155] research method

[0156] The study, called a single-center feasibility study, compared the effects of EPT combined with invasive bleomycin with conventional surgery, radiation and / or systemic chemotherapy effects were compared. Fifty research subjects were enrolled in this study. All study subjects were assessed by physical examination and biopsy prior to treatment. Subjects were assessed weekly postoperatively for 4-6 weeks and monthly thereafter for a total of 12 months. A biopsy of the tumor site is done about 8 to 12 weeks after treatment. Compute...

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Abstract

A method and apparatus for in vivo electroporation therapy. Using electroporation therapy (EPT) as described in the invention, tumors treated by a combination of electroporation using the apparatus of the invention and a chemotherapeutic agent caused regression of tumors in vivo. In one embodiment, the invention provides a method of EPT utilizing low voltage and long pulse length for inducing cell death. One embodiment of the invention includes a system for clinical electroporation that includes a needle array electrode having a "keying" element that determines the set point of the therapy voltage pulse and / or selectable array switching patterns. A number of electrode applicator designs permit access to and treatment of a variety of tissue sites. Another embodiment provides a laparoscopic needle applicator that is preferably combined with an endoscope for minimally invasive EPT.

Description

[0001] This application is a divisional application of a patent application with an application date of July 31, 1998 and an application number of 98801461.0. technical field [0002] The present invention relates generally to the use of electrical pulses to increase the permeability of cells, and more particularly to the in vivo delivery of pharmaceutical compounds and genes into cells by electroporation therapy (EPT) using controllable electric fields, the Electroporation therapy may also be referred to as cell poration therapy (CPT) or electrochemotherapy (ECT). Background technique [0003] In the 1970s, it was discovered that electric fields could be used to create pores in cells without causing permanent damage to the cells. This discovery made it possible to deliver macromolecules into the cytoplasm. It is known that genes and other molecules such as drug compounds can enter living cells through a process called electro...

Claims

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Application Information

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IPC IPC(8): A61B17/34A61N1/04A61B18/14A61K31/7088A61K38/16A61M37/00A61N1/00A61N1/05A61N1/30A61N1/32A61P35/00
CPCA61N1/0502A61N1/325A61N1/327A61P35/00A61N1/04
Inventor G·A·霍夫曼S·B·德弗S·C·迪姆默J·I·勒瓦特G·S·南达
Owner GENETRONICS INC
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