A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without HyperAcute®-Pancreas (Algenpantucel-L) Immunotherapy in Subjects With Surgically Resected Pancreatic Cancer

Inclusion Criteria:

- A histological diagnosis of adenocarcinoma of the pancreas confirmed by pathology.

- American Joint Committee on Cancer (AJCC) Stage I or II Pancreatic carcinoma.
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 be able to take in adequate daily calorie intake based on judgment of
clinical investigator.

- Adequate organ function including:

- A. Marrow: white blood cells (WBC) ≥3000/mm3 and platelets ≥100,000/mm3.

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

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

- First vaccination must be within 10 weeks after surgery.

- Patients must have the ability to understand the study, its inherent risks, side
effects and potential benefits and be able to give written informed consent to
participate. Patients may not be consented by a durable power of attorney (DPA).

- 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. Suspicious lesions on CT scans must be reviewed by a second,
different reviewer. If active disease not ruled out by second, different reviewer (at
clinical institution), a positron emission tomography (PET) CT or further imaging
tests or histology may be needed to rule out disease before enrollment is allowed.

- Other malignancy within five years, unless the probability of recurrence of the prior
malignancy is <5% as determined by the Principal Investigator based on available
information. 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 twice a day (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 48 hours 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 HyperAcute® immunotherapy.

- 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 14 days of first vaccination).

- Known HIV positive.