A Study of GL-ONC1, an Oncolytic Vaccinia Virus, in Patients With Advanced Peritoneal Carcinomatosis

Inclusion Criteria:

1. Diagnosis of histologically or cytologically documented, advanced stage ofperitoneal carcinomatosis that is refractory to standard therapy, exhibiting alikely survival of > 4 months as being judged clinically.

2. Evidence of measurable disease.

3. Age ≥ 18 years.

4. ECOG (Eastern Cooperative Oncology Group Performance Status) ≤ 2.

5. Required baseline laboratory data include:

• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.

• Platelets ≥ 75 ×109/L

• Haemoglobin ≥ 9.5 g/dL

• Serum creatinine ≤ 2 × upper limit of normal(ULN)

• Total Bilirubin ≤ 5 × ULN

• AST/ALT ≤ 7.5 × ULN

• Negative pregnancy test for females of childbearing potential

• Serum albumin ≥ 2.5 g/dL.

• If serum albumin level is < 2.5/dL,albumin substitution should take place untilthe threshold of ≥ 2.5 g/dL.

6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests,implantation of the indwelling peritoneal catheter, as well as the respectivedrainage procedures.

7. All patients must agree to use highly effective contraception.

Exclusion Criteria:

1. Patients exhibiting objective evidence at baseline of brain metastases are excludedfrom participating.

2. Pregnant or breast-feeding women.

3. Primary tumors and metastases to tissues/organs which, under clinical judgment, willlikely hinder survival for at least the next 4 months.

4. Patients with fever, any active immunosuppressive systemic infection or a suppressedimmune system, including known HIV, as assessed within 14 days prior to studyenrolment.

5. Concurrent vaccination or immunotherapy for 28 days before study therapy and duringstudy treatment.

6. Patients on immunosuppressive therapy or with immune system disorders, includingautoimmune diseases. Concurrent steroid use of not more than an equivalent of 20mg/day prednisolone is allowed.

7. Prior splenectomy.

8. Previous organ transplantation.

9. Fully therapeutic coagulation therapy that does not allow the intraperitonealinsertion of a permanent catheter.

10. Patients with clinically significant dermatological disorders(e.g., eczema orpsoriasis), any skin lesions or ulcers, any history of atopic dermatitis, or anyhistory of Darier's disease (Keratosis Follicularis).

11. Clinically significant cardiac disease (New York Heart Association, Class III or IV:see Appendix 10)

12. Known allergy to ovalbumin or other egg products.

13. Concurrent use of antiviral agents active against vaccinia virus.

14. Prior gene therapy treatment or prior therapy with cytolytic virus of any type.