Antigen-specific Cancer Immunotherapy (TG01) and Gemcitabine as Adjuvant Therapy in Resected Pancreatic Cancer

Exclusion Criteria

• •1. Has received an investigational drug within 4 weeks prior to Trial drug administration
• •2. Has received previous therapy for pancreatic cancer including radiation or chemotherapy (except for the primary resection or primary neoadjuvant chemotherapy).
• •3. Is currently receiving any agent with a known effect on the immune system, unless at dose levels that are not immunosuppressive (e.g. Prednisone at 10 mg/day or less or as inhaled steroid at doses used for the treatment of asthma).
• •4. Has any other serious illnesses or medical conditions such as, but not limited to:
• •* Any uncontrolled infection
• •* Uncontrolled cardiac failure classification III or IV (NY Heart Association)
• •* Uncontrolled systemic and gastro-intestinal inflammatory conditions
• •* Bone marrow dysplasia
• •* History of auto-immune disease
• •* History of adverse reactions to vaccines
• •5. Known history of positive tests for HIV/AIDS, hepatitis B or C
• •6. Pregnant or lactating females or have no pregnancy test at baseline (postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential).
• •7. Contraindication to gemcitabine treatment
• •8. Have had any other malignancies within last 3 years (except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer)
• •9. Known malignant brain lesion(s)
• •10. Are unlikely to start chemotherapy within 12 weeks of surgery (e.g. delayed wound healing, or infection, etc.)
• •11. Are not expected to complete 6 cycles of chemotherapy
• •12. Are planned to receive yellow fever or other live (attenuated) vaccines during the course of study