Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms

In this open-label, dose rising trial, subjects with mucinous cystic pancreatic neoplasms
will receive intracystic NanoPac® via endoscopic ultrasound-guided fine needle injection
(EUS-FNI).

In the dose escalation phase, subjects will be enrolled in sequential cohorts of NanoPac® at
6, 10, and 15 mg/mL at volumes sufficient to fill the cyst, at least equal to the amount of
cyst fluid aspirated. Each cohort will have three subjects, with cohorts enrolled
sequentially starting at the lowest concentration. Following Data Safety Monitoring Board
(DSMB) review of the cohort data, the next cohort may begin enrolling, an additional three at
the current dose may be enrolled, or if the first dose does not provide adequate safety and
tolerability the study may be halted. The dose determined to be the most suitable for further
evaluation, defined as the highest dose with an acceptable safety and tolerability profile
(as determined by the DSMB), will be the dose used in the second phase of the study which
will enroll 9 additional subjects. Subjects enrolled in the second phase of the study will
also receive a second injection of NanoPac at the same dose 12 weeks after the first NanoPac
injection..

Plasma samples will be taken on the day(s) of NanoPac® injection at 1 and 2 hours after
injection, as well as at each of the subsequent study visits, to characterize the
pharmacokinetics (PK) of intracystic NanoPac®.

Subjects will be followed for 6 months after the first NanoPac® injection for safety,
tolerability and cyst response to therapy (as shown by imaging). Cyst fluid will also be
extracted and analyzed for cyst fluid markers.

Inclusion Criteria:

- Signed informed consent;

- Patients over the age of 18;

- Recently confirmed mucinous cystic pancreatic neoplasm; may be confirmed by presence
of mucin, cyst fluid carcinoembryonic antigen (CEA) above 192 U/L, or other reliable
diagnostic means such as endomicroscopy; KRAS analysis may also be performed at the
discretion of the Investigator;

- Unilocular cyst with diameter of at least 1.5 cm but no more than 4 cm;

- Normal hematologic, hepatic, and renal function at study entry;

- Appropriate steps taken to minimize or avoid the potential for pregnancy for subjects
of child-bearing potential.*

- Note: A female patient is considered to be of childbearing potential unless she
has had a hysterectomy, is at least one year postmenopausal or has undergone
tubal ligation. For the purposes of this study, adequate birth control includes
at least one medically approved and highly effective method of birth control,
defined as those which result in a low failure rate (i.e., < 1% per year) when
used consistently and correctly, such as implants, injectables and oral
contraceptives combined with the use of condoms. Only male patients whose
vasectomy has been confirmed by semen analysis at least 3 months after the
vasectomy are allowed not to use acceptable contraceptive methods.

Exclusion Criteria:

- Positive cytology indicating malignancy;

- Thrombotic or embolic events;

- Known hypersensitivity to study agent;

- Known drug or alcohol abuse;

- Pregnant or breastfeeding women.