A Phase 2 Randomized, Placebo-controlled, Double-blind Study of the Efficacy of MORAb-009 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer.

Inclusion Criteria:

1. Female or male subjects, ≥ 18 years of age, with cytologically or histologically
confirmed diagnosis of pancreatic adenocarcinoma.

2. Must have measurable disease, as defined by RECIST or evaluable by clinical
signs/symptoms (e.g. ascites, pleural effusion, or lesions of less than 2 cm)
supported by biomarker, radiologic, or pathologic studies conducted within 4 weeks
prior to study entry.

3. Must have unresectable disease and have received no prior chemotherapy or radiation
therapy for their pancreatic cancer.

4. Karnofsky performance status of greater than or equal to 70 %.

5. Female subjects of childbearing potential and all male subjects must be surgically
sterile or consent to use a medically acceptable method of contraception throughout
the study period.

6. Other significant medical conditions must be well-controlled and stable in the
opinion of the investigator for at least 30 days prior to Study Day 1.

7. Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin
≥ 9 g/dL Serum bilirubin ≤ 2.0 mg/dL Aspartate transaminase (AST)* ≤ 5 x upper limit
of normal (ULN) Alanine transaminase (ALT)* ≤ 5 x ULN Alkaline phosphatase* ≤ 5 x ULN
Serum creatinine ≤ 2.0 mg/dL Stenting to reduce liver functions to qualifying levels
is permitted.

* Subjects with liver function abnormalities greater than the ULN are eligible only
if in the opinion of the investigator they are due to disease obstruction of the bile
ducts or metastatic disease.

8. Must be willing and able to provide written informed consent.

Exclusion Criteria:

1. Known central nervous system (CNS) tumor involvement.

2. Evidence of other active malignancy requiring treatment.

3. Clinically significant heart disease (e.g., congestive heart failure of New York
Heart Association Class 3 or 4 angina not well controlled by medication, or
myocardial infarction within 6 months).

4. Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note:
Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal
supraventricular tachycardia [SVT], are eligible).

5. Active serious systemic disease, including active bacterial or fungal infection.

6. Active viral hepatitis or symptomatic human immunodeficiency virus (HIV) infection.

7. Prior chemotherapy or radiation therapy for their pancreatic cancer.

8. Breast-feeding, pregnant, or likely to become pregnant during the study.

9. No other concurrent immunotherapy (e.g., immunosuppressants or chronic use of
systemic corticosteroids with the exception that low-dose corticosteroids are
allowed)

10. Known hypersensitivity to a monoclonal antibody or biologic therapy.