Gene Transfer for Intractable Pain: A Phase I Clinical Trial to Determine the Maximum Tolerable Dose of a Replication-Defective Herpes Simplex Virus Type I (HSV-1) Vector Expressing Human Preproenkephalin (NP2) in Patients With Malignancies
Therapeutic HSV-based vectors deliver genes from skin inoculation to sensory neurons to
interrupt pain signaling at the spinal level. Side effects may be limited by the focal
distribution of vector delivery and preproenkephalin expression. Preproenkephalin is a
natural human gene that produces peptides that bind to opioid receptors in the body. The
therapeutic being evaluated, NP2, is a replication defective herpes simplex type 1 virus
(HSV-1) modified to express the human preproenkephalin gene that has demonstrated efficacy
in numerous model of pain, including pain caused by cancer.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety measured by vital signs, physical exam findings, clinical laboratory analyses and treatment related Adverse Events (AE).
4 Months
Yes
David J Fink, MD
Principal Investigator
University of Michigan Department of Neurology
United States: Food and Drug Administration
NP2/P1/07/1
NCT00804076
February 2008
September 2013
Name | Location |
---|---|
University of Michigan Medical Center | Ann Arbor, Michigan 48104-0914 |
Center For Clinical Research | Winston Salem, North Carolina 27103 |
Louisiana Research Associates | New Orleans, Louisiana 70114 |
Advanced Pharma CR | Miami, Florida 33175 |
Pain Research of Oregon, LLC | Eugene, Oregon 97401 |