NP2 Enkephalin For Treatment of Intractable Cancer Pain

Diamyd Medical

Status and phase: Completed; Phase 2

Conditions: Neoplasms; Intractable Pain

Treatments: Biological: Placebo; Biological: NP2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01291901

NP2/P2/10/2

Details and patient eligibility

About

The purpose of this study is to examine the impact of intradermal delivery of NP2 on pain scores and pain medication usage in subjects with intractable pain due to malignant disease. A second purpose is to confirm safety and secondary efficacy measurements.

Full description

Chronic severe pain remains a significant unmet medical need in patients that have progressive cancer. Existing treatments have limited efficacy and also suffer significant side effects. This is a multi-center, randomized, double blind, placebo-controlled clinical trial designed to evaluate the impact of intradermal injection of NP2 in subjects who have intractable pain due to malignant disease. NP2 is a gene transfer vector engineered to express human preproenkephalin, a gene naturally involved in pain control. Delivery of NP2 directly to the site of pain caused by cancer is intended to provide increased Enkephalin peptides, which bind to opioid receptors, that may allow better pain control.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Histologically confirmed malignant disease.
• Intractable pain related to malignancy.
• Females must be postmenopausal or practicing birth control.
• Able to provide appropriate written consent.

Main Exclusion Criteria:

• Positive pregnancy test prior to receiving study treatment.
• Serious uncontrolled medical condition other than malignancy (e.g. congestive heart failure, coagulopathy, uncontrolled diabetes).
• Evidence of active Hepatitis B, Hepatitis C, or HIV infection.
• Evidence of viral, bacterial, or fungal infection in the planned treatment area.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups, including a placebo group

Active NP2

Experimental group

Description:

Single intradermal dose of active NP2. An open label study extension will offer up to two additional doses of active NP2 between weeks 4-10 following the previous dose.

Treatment:

Biological: NP2

Placebo

Placebo Comparator group

Description:

Single intradermal dose of placebo (vehicle). An open label study extension will offer up to two additional doses of active NP2 between weeks 4-10 following the previous dose.

Treatment:

Biological: Placebo