A Phase II Study of HyperAcute(R)-Pancreatic Cancer Vaccine in Subjects With Surgically Resected Pancreatic Cancer

Inclusion Criteria:

- A histological diagnosis of adenocarcinoma of the pancreas.

- AJCC Stage I or II Pancreatic carcinoma (See Appendix A). Patients must have
undergone surgical resection for the tumor and extent of resection must be either R0
(complete resection with grossly and microscopically negative margins of resection)
or R1 (grossly negative but positive microscopically margins of resection).

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

- Serum albumin ≥ 2.0 gm/dL.

- Expected survival ≥ 6 months.

- Subjects must have a negative serology for HIV prior to entering study.

- Subjects must be able to take in ≥ 1500 calories daily.

- Adequate organ function including:

- Marrow: WBC ≥3000/mm3 and platelets ≥100,000/mm3.

- Hepatic: serum total bilirubin ≤ 2 x ULN mg/dL, ALT (SGPT) and AST (SGOT) ≤3 x upper
limit of normal (ULN).

- Renal: serum creatinine (sCr) ≤2.0 x ULN, or creatinine clearance (Ccr) ≥30 mL/min.

- First vaccination must be within 6 weeks after surgery.

- Patients must have the ability to understand the study, its inherent risks, side
effects and potential benefits and be able give written informed consent to
participate.

- All subjects of child producing potential must agree to use contraception or
avoidance of pregnancy measures while enrolled on study and receiving the
experimental product, and for one month after the last immunization.

Exclusion Criteria:

- Age <18-years-old.

- Active metastases.

- Other malignancy within five years, unless the probability of recurrence of the prior
malignancy is <5%. Patient's curatively treated for squamous and basal cell
carcinoma of the skin or patients with a history of malignant tumor in the past that
have been disease free for at least five years are also eligible for this study.

- History of organ transplant.

- Current, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.

- Subjects taking chronic systemic corticosteroid therapy for any reason are not
eligible. Subjects may receive steroids as prophylactic anti-emetics, not to exceed
10 mg Decadron weekly. Subjects may also receive pulse doses for Gemcitabine
hypersensitivity, not to exceed Decadron 8 mg BID x 3 days prior to start day of
Gemcitabine. Subjects receiving inhaled or topical corticosteroids are eligible.
Subjects who require chronic systemic corticosteroids after beginning vaccination,
will be removed from study.

- Significant or uncontrolled congestive heart failure (CHF), myocardial infarction or
significant ventricular arrhythmias within the last six months.

- Active infection or antibiotics within 1-week prior to study, including unexplained
fever (temp > 38.1C).

- Autoimmune disease (e.g., systemic lupus erythematosis (SLE), rheumatoid arthritis
(RA), etc.). Patients with a remote history of asthma or mild active asthma are
eligible.

- Other serious medical conditions that may be expected to limit life expectancy to
less than 2 years (e.g., liver cirrhosis) or a serious illness in medical opinion of
the clinical investigator.

- Any condition, psychiatric or otherwise, that would preclude informed consent,
consistent follow-up or compliance with any aspect of the study (e.g., untreated
schizophrenia or other significant cognitive impairment, etc.).

- A known allergy to any component of the vaccine or cell lines.

- Pregnant or nursing women due to the unknown effects of vaccination on the developing
fetus or newborn infant. (For patients with child bearing potential, a βHCG must be
completed within 7 days of first vaccination).