First in Man Clinical Study to Evaluate Safety and Tolerability of an Oncolytic Adenovirus in Prostate Cancer Patients.

Exclusion Criteria

• •1. Tumor not accessible for injection
• •2. Prior treatment of prostate cancer with radiation therapy or brachytherapy
• •3. Prior use of chemotherapy/hormone therapy for treatment of cancer
• •4. Target tumor adherent to a major vascular structure
• •5. Participation in any investigational drug study within the last 12 months prior to first administration of ORCA-010
• •6. Clinically significant active infection (viral or bacterial)
• •7. Known immunosuppressive diseases (e.g. HIV, Hepatitis B and C)
• •8. History of any other oncological malignancy, excluding basal cell carcinoma of the skin, in the past 5 years
• •9. Not willing to refrain from sexual activities or use a double barrier contraceptive device (condom with foam or vaginal suppository, diaphragm with spermicide) after administration of ORCA-010 and until 42 days after the last ORCA-010 administration
• •10. Severe obesity defined as Body Mass Index (BMI) \> 30 kg/m2
• •11. Positive for adenovirus in throat swap or serum as determined by PCR at screening
• •12. Recent (within 3 months prior to enrolment in the study) history of alcohol abuse or other substances such as barbiturates, cannabinoids and amphetamines or a positive urine screen for drugs of abuse
• •13. Use of medication known to have immunosuppressive effects, except topical/inhaled steroids under 10 mg/day prednisolone equivalent (See Appendix 7)
• •14. Use of systemic antiviral medication within 3 months prior to enrolment in the study
• •15. Use of any anti-coagulants/blood thinner except for ASA 81mg
• •16. Any condition that in the opinion of the Investigator could interfere with the conduct of the study
• •17. For Part B only: Subjects enrolled in Part A of the study