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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NP2 | Experimental | Intradermal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NP2 | Biological | Intradermal injection of NP2 at doses ranging from 10e7 to 10e9 pfu at the site of pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by vital signs, physical exam findings, clinical laboratory analyses and treatment related Adverse Events (AE). | 4 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate changes in cancer-related pain | 4 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J Fink, MD | University of Michigan Department of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Pharma CR | Miami | Florida | 33175 | United States | ||
| Louisiana Research Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11319622 | Background | Goss JR, Mata M, Goins WF, Wu HH, Glorioso JC, Fink DJ. Antinociceptive effect of a genomic herpes simplex virus-based vector expressing human proenkephalin in rat dorsal root ganglion. Gene Ther. 2001 Apr;8(7):551-6. doi: 10.1038/sj.gt.3301430. | |
| 12620604 | Background | Hao S, Mata M, Goins W, Glorioso JC, Fink DJ. Transgene-mediated enkephalin release enhances the effect of morphine and evades tolerance to produce a sustained antiallodynic effect in neuropathic pain. Pain. 2003 Mar;102(1-2):135-42. doi: 10.1016/s0304-3959(02)00346-9. |
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| New Orleans |
| Louisiana |
| 70114 |
| United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 49109 | United States |
| Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Pain Research of Oregon, LLC | Eugene | Oregon | 97401 | United States |
| 12402268 | Background | Goss JR, Harley CF, Mata M, O'Malley ME, Goins WF, Hu X, Glorioso JC, Fink DJ. Herpes vector-mediated expression of proenkephalin reduces bone cancer pain. Ann Neurol. 2002 Nov;52(5):662-5. doi: 10.1002/ana.10343. |
| 18841093 | Background | Glorioso JC, Fink DJ. Herpes vector-mediated gene transfer in the treatment of chronic pain. Mol Ther. 2009 Jan;17(1):13-8. doi: 10.1038/mt.2008.213. Epub 2008 Oct 7. |