The primary purpose of this study is to examine the safety of NP2 (a nonreplicating HSV-based vector expressing enkephalin) in patients with cancer pain. The secondary purpose is to evaluate efficacy.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Intradermal injection of NP2 at doses ranging from 10e7 to 10e9 pfu at the site of pain.
Advanced Pharma CR
Miami, Florida, United States
Louisiana Research Associates
New Orleans, Louisiana, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Center for Clinical Research
Winston-Salem, North Carolina, United States
Safety measured by vital signs, physical exam findings, clinical laboratory analyses and treatment related Adverse Events (AE).
Time frame: 4 Months
Evaluate changes in cancer-related pain
Time frame: 4 Months
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Pain Research of Oregon, LLC
Eugene, Oregon, United States