Phase II Study of Intraperitoneal NanoPac® in Patients With Ovarian Cancer

Research has shown that the administration of chemotherapy directly into the peritoneal
cavity (intraperitoneal [IP] chemotherapy) may provide a significant survival benefit to
women with ovarian cancer when combined with cytoreductive surgery and IV chemotherapy.

This study will include a dose-finding phase and an efficacy phase to evaluate IP NanoPac®
administered immediately post-cytoreductive surgery in women with ovarian cancer. In the
dose-finding phase, subjects will be enrolled in dose-escalated cohorts of three subjects and
receive IP NanoPac® at 100, 200, 300, or 400 mg/m2 plus standard of care (SOC) IV
chemotherapy. Subjects will be followed for disease status for 12 months. The two best doses
from the dose-finding phase will be determined. In the efficacy phase, subjects will be
randomized 1:1:1 to one of the two best doses plus SOC IV chemotherapy or SOC alone.

Inclusion Criteria:

- Epithelial ovarian cancer which is contained within the abdomen, but may include
pleural effusion if that is the limit of non-peritoneal cavity disease. If subject has
recurrent epithelial ovarian cancer, the disease must be platinum sensitive
(recurrence >6 months from prior chemotherapy regimen that included a platinum agent
and cytoreductive surgery)

- Subject appropriate for cytoreductive surgery and treatment with IV platinum and
paclitaxel

- Minimal or non-symptomatic ascites

- ≥18 years old

- Signed informed consent

Exclusion Criteria:

- Epithelial ovarian cancer outside of the peritoneal cavity, with the exception of
pleural effusions

- Anticipated use of concomitant chemotherapy (other than the protocol-specified
agents), immunotherapy, or radiation therapy

- Treatment with a prior investigational agent within 30 days of planned instillation of
NanoPac®, with the exception of subjects participating in poly (ADP-ribose) polymerase
(PARP) inhibitor trials. These subjects must discontinue the investigational agent
prior to surgery

- Known sensitivity to any of the study medication components or the chemotherapy
regimen

- History of prior malignancy other than ovarian that has not been in remission for >5
years, with the exception of basal cell or squamous cell carcinoma or cervical
carcinoma in situ on biopsy

- Ileostomy or hepatic resection during current cytoreductive surgery

- Women of childbearing potential not practicing adequate forms of birth control