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

Inclusion Criteria:

1. Patients with intractable pain from malignant disease with a 5 year projected
survival of less than 25%.

2. Female patients of childbearing potential who have a negative pregnancy test and
using birth control.

3. Patients who have not received recent treatment with a radiation, chemotherapeutic or
immunotherapeutic agent and are not expected to undergo such treatment 28 days after
injection of NP2.

4. Patients who have not had surgical stabilization/resection within 4 weeks of
Screening and have no plans for additional surgical procedures.

5. Patients with adequate bone marrow function, IgG levels greater than 565 mg% and CD4
count greater than 500. .

Exclusion Criteria:

1. Patients with serious uncontrolled medical conditions other than malignancy.

2. Patients with severe liver or renal impairment

3. Patients currently or previously with positive serology for HIV, Hepatitis B or
Hepatitis C.

4. Patients with a hemoglobin <9 gm% or uncontrolled coagulopathy or bleeding diathesis.

5. Patients with a clinical diagnosis of any active herpes infection within the past 6
months.

6. Patients who have been vaccinated to prevent HSV infection or a history of shingles
or the presence of active shingles.