BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients

This is a Phase 2 multicenter, open-label, non-randomized study to examine the safety and
effectiveness of BPM31510 administered over 144-hours (two 72-hour 110mg/Kg doses) continuous
intravenous (IV) infusion in combination with gemcitabine in advanced pancreatic cancer
patients as 2nd / 3rd line therapy.

Cycle 1 of therapy is 6 weeks in duration with BPM31510 administered twice weekly on Tuesdays
and Fridays for 6 weeks plus gemcitabine administered on Mondays, Days 21, 28 and 35.

Cycles 2-12 are 4 weeks in duration with BPM31510 administered twice weekly on Tuesdays and
Fridays for 4 weeks plus gemcitabine administered on Mondays, Days 7, 14 and 21. Response
will be assessed after Cycle 2 (10 weeks) and patients who continue onto Cycles 2-12 will be
assessed every 2 cycles (8 weeks).

Patients will continue BPM31510 in combination with gemcitabine, for a maximum of 12 cycles
in the absence of intolerable toxicity and progression. If gemcitabine is discontinued due to
chemotherapy-related toxicity, patients may continue to receive BPM31510 as monotherapy.

Patients who experience disease progression but are, in the opinion of the investigator,
receiving clinical benefit may continue BPM31510 as a monotherapy or in combination with
gemcitabine or as a monotherapy pending approval from the Sponsor.

Inclusion Criteria:

- The patient has a histologically or cytologically confirmed metastatic pancreatic
adenocarcinoma.

- The patient has undergone at least one prior, but no more than 2 prior standard,
therapies for pancreatic cancer.If the patient has had prior gemcitabine treatment,
the last date of gemcitabine administration-should be > 3 months prior to screening
for the study. All patients who have previously received gemcitabine should be
discussed with the medical monitor during screening

- The patient is at least 18 years old.

- The patient has an Eastern Cooperative Oncology Group (ECOG) performance status

- Measurable tumor lesions according to RECIST 1.1 criteria (Section 10.2).

- In the opinion of the Investigator, the patient has a life expectancy of > 3 months.

- Sexually active patients and their partners agree to use an accepted method of
contraception during the course of the study (Appendix C:Guidelines Regarding Women of
Childbearing Potential).

- Female patients of childbearing potential must have a negative pregnancy test within 1
week prior to beginning study treatment.

- The patient has adequate organ and marrow function as follows:

- absolute Neutrophil Count (ANC) ≥ 1500 mm3, platelets ≥ 100,000/mm3, hemoglobin ≥
9 g/dL,

- serum creatinine < upper limit of normal (ULN);

- total bilirubin < 1.5 X (ULN) ; alanine aminotransferase (ALT), aspartate
transaminase (AST) ≤ 2.5 times the upper limit of normal (ULN) if no liver
involvement or ≤ 5 times the upper limit of normal with liver involvement.

- The patient has serum electrolytes (including calcium, magnesium, phosphorous, sodium
and potassium) within normal limits (supplementation to maintain normal electrolytes
is allowed).

- The patient has adequate coagulation: prothrombin time (PT) and an International
Normalized Ratio (INR), and partial thromboplastin time (PTT) ≤ 1.5 times the upper
limit of normal (ULN),

- In the opinion of the Investigator, the patient is capable of understanding and
complying with the protocol and has signed the informed consent document.

Exclusion Criteria:

- The patient has uncontrolled intercurrent illness including, but not limited to
uncontrolled infection, symptomatic congestive heart failure (NYHA class III and IV),
uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements.

- The patient has active heart disease including myocardial infarction within previous 3
months, symptomatic coronary artery disease, arrhythmias not controlled by medication,
unstable angina pectoris, or uncontrolled congestive heart failure (NYHA class III and
IV).

- The patient has received chemotherapy or radiotherapy within 4 weeks or has received
nitrosoureas or mitomycin C within 6 weeks prior to the first dose of study drug.

- The patient has received radiation to ≥ 25% of his or her bone marrow within 4 weeks
of the first dose of study drug.

- The patient has received an investigational drug within 30 days of the first dose of
study drug.

- Evidence of central nervous system (CNS) metastasis (negative imaging study, if
clinically indicated, within 4 weeks of Screening Visit).

- History of other malignancies (except adequately treated Stage 1 cancer, cured basal
cell carcinoma, superficial bladder cancer, Breast ductal carcinoma in situ (DCIS), or
carcinoma in situ of the cervix) unless documented free of cancer for ≥5 years.

- The patient has not recovered to grade ≤ 1 from adverse events (AEs) due to
investigational drugs or other medications, which were administered more than 4 weeks
prior to the first dose of study drug.

- The patient is pregnant or lactating.

- The patient is known to be positive for the human immunodeficiency virus (HIV). The
effect of BPM31510 on HIV medications is unknown. Note: HIV testing is not required
for eligibility, but if performed previously and was positive, the patient is
ineligible for the study.

- The patient has an inability or unwillingness to abide by the study protocol or
cooperate fully with the Investigator or designee.

- The patient is receiving digoxin, digitoxin, lanatoside C or any type of digitalis
alkaloids.

- The patient has uncontrolled or severe coagulopathies or a history of clinically
significant bleeding within the past 6 months, such as hemoptysis, epistaxis,
hematochezia, hematuria, or gastrointestinal bleeding.

- The patient has a known predisposition for bleeding such as von Willebrand's disease
or other such condition.

- The patient requires therapeutic doses of any anticoagulant, including low molecular
weight heparin (LMWH). Concomitant use of warfarin, even at prophylactic doses, is
prohibited.