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Technology evaluation: VEGF165 gene therapy, Valentis Inc
1Department of Medicine, Duke University Medical Center, Durham, NC 27710, USA. m.morse@cgct.duke.edu
Current Opinion in Molecular Therapeutics
|March 16, 2001
Summary
Valentis is developing a non-viral gene therapy using vascular endothelial growth factor (VEGF165) for cardiovascular diseases. Clinical trials are underway to assess its efficacy in peripheral and coronary artery disease patients.
Area of Science:
- Biotechnology
- Cardiovascular Medicine
- Gene Therapy
Background:
- Valentis Inc. is advancing non-viral gene therapy.
- The therapy utilizes vascular endothelial growth factor (VEGF165).
- Proprietary PINC polymer is used for plasmid condensation.
Purpose of the Study:
- To evaluate VEGF165 gene therapy in Phase II angioplasty trials.
- To assess the treatment of peripheral vascular disease and coronary artery disease.
- To demonstrate local gene delivery and expression in vascular smooth muscle cells.
Main Methods:
- Two physician-initiated Phase II angioplasty trials.
- Utilizing a DOTMA-based cationic lipid gene delivery system.
- Employing a local collar-reservoir delivery device for VEGF165 gene administration.
Main Results:
- Ongoing clinical trials for peripheral and coronary artery disease.
- Trial completion dates have been updated.
- Preclinical studies are being conducted to support Investigational New Drug (IND) submission.
Conclusions:
- VEGF165 gene therapy shows promise for cardiovascular applications.
- Further clinical evaluation is necessary to confirm efficacy and safety.
- Advancement of non-viral gene therapies for ischemia is a key objective.