(PM-01) IMPRIME PGG® With BTH1704 and Gemcitabine for Advanced Pancreatic Cancer

Inclusion Criteria:

1. Male or female ≥ 18 years

2. Histologically or cytologically confirmed adenocarcinoma of the pancreas, including
pancreatic adenosquamous carcinoma, pancreatic anaplastic adenocarcinoma, pancreatic
signet ring carcinoma, papillary mucinous carcinoma, acinar cell carcinoma, and
ampulla of vater carcinoma,that is locally advanced (not able to proceed with
surgery), recurrent, or metastatic (mixed adenocarcinoma of the pancreas is
acceptable where the invasive component is predominantly adenocarcinoma)

3. Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a
target lesion according to RECIST 1.1

4. Has an ECOG PS of 0, 1, or 2

5. Has been off chemotherapy for > or = 2 weeks

6. Has a patent biliary stent if required for biliary ductal obstruction, has adequate
nutritional intake, and pain which is stable for a minimum of 24 hrs (pain score ≤
3/10)

7. Has total bilirubin < 2 mg/dL, AST and ALT < 3.0 × ULN or < 5 x ULN for subjects with
known hepatic metastases

8. Has serum creatinine < 2.5 × ULN

9. Has hemoglobin ≥ 9 g/dL, ANC ≥ 1.0 × 10^9/L, and platelet count ≥ 100 × 10^9/L

10. Must be willing and able to comply with study

11. Has read, understood and signed the ICF

12. Women of childbearing potential must not be pregnant or breast-feeding. In addition,
a medically acceptable method of birth control must be used or total abstinence.
Women who are postmenopausal for at least 1 year or surgically sterile (bilateral
tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be
WOCP.

13. Men who are not surgically or medically sterile must agree to use an acceptable
method of contraception. Male patients with female sexual partners who are pregnant,
possibly pregnant, or who could become pregnant during the study must agree to use
condoms at least 30 days after the last dose of study drug. Total abstinence is an
acceptable alternative.

14. Prior systemic treatments for metastatic disease are permitted, including targeted
therapies, biologic response modifiers, chemotherapy, hormonal therapy, or
investigational therapy.

15. Availability of tissue if applicable (from the primary tumor or metastases)for
banking

16. Willingness to donate blood for biomarker studies

17. Must have received at least one prior systemic chemotherapy on which disease
progressed

Exclusion Criteria:

1. Has a diagnosis of resectable pancreatic adenocarcinoma

2. Had surgery within 4 weeks prior to study treatment

3. Has either untreated or symptomatic CNS mets

4. Has a known hypersensitivity to BTH1704, murine proteins, or any component of BTH1704

5. Has a known hypersensitivity to baker's yeast

6. Has had previous exposure to Imprime PGG

7. Has previously received an organ or progenitor/stem cell transplant

8. Has a history of blood clots, pulmonary embolism, or DVT unless controlled by
anticoagulant treatment

9. Has a known history of HIV positivity or untreated & uncontrolled hepatitis B or C

10. Has any clinically significant infection

11. Has any other severe, uncontrolled medical condition, including uncontrolled DM or
unstable CHF or has a known or suspected allergy to the study drug

12. Other severe acute or chronic medical or psychiatric conditions, or laboratory
abnormality that may increase the risk associated with study participation

13. Presence of any non-healing wound, fracture, or ulcer

14. Has any condition that, in the opinion of the investigator, might jeopardize the
safety of the patient or interfere with protocol compliance

15. Has any mental or medical condition that prevents the patient from giving informed
consent

16. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to gemcitabine or drugs to formulate.