Gene therapy strategies based on plasmid DNA (pDNA) delivery have been proposed for a variety of applications including vaccines and endogenous production of therapeutic proteins. Unfortunately, clinical implementation of these approaches has been hampered by the lack of clinically viable gene delivery systems. Recent studies suggest that in vivo electroporation can dramatically improve the delivery of pDNA. However, the current methods and devices are inappropriate for widespread clinical application. A critical step is the development of safe, reliable, and effective means of administration. It must also be simple to apply and result in minimal discomfort for the patient. During Phase I, Ichor investigated the basic feasibility of an integrated application device suitable for intra-muscular gene delivery. This work demonstrated the basic feasibility of the proposed device and led to further refinement of the concept. During Phase II, Ichor will develop an application system that is suitable for intra-muscular gene delivery in humans. The proposed scope of work includes research and development, manufacture of functional prototypes, and finally, safety and performance validation studies. Following the successful completion of SBIR Phase 11, the proposed system will be utilized in clinical studies for the intra-muscular delivery of novel gene-based products.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44GM064909-02A1
Application #
6694708
Study Section
Special Emphasis Panel (ZRG1-SSS-2 (10))
Program Officer
Wolfe, Paul B
Project Start
2002-02-04
Project End
2005-06-30
Budget Start
2003-07-01
Budget End
2004-06-30
Support Year
2
Fiscal Year
2003
Total Cost
$382,550
Indirect Cost
Name
Ichor Medical Systems, Inc.
Department
Type
DUNS #
956868020
City
San Diego
State
CA
Country
United States
Zip Code
92121