PTC-596 in Women With Ovarian Cancer Receiving Neoadjuvant Chemotherapy

For all cohorts, PTC596 will be orally administered at least 30 minutes prior to IV
chemotherapy, twice a week on day 1, 4, 8, 11, 15, 18 of each 21-day cycle. The starting dose
is 1.3 mg/kg in cohort 1. Carboplatin (AUC = 6 mg/mL min) will be administered IV on day 1
and paclitaxel (80 mg/m2) will be administered IV once a week on days 1, 8 and 15 of each
21-day cycle. Dose escalation levels for PTC- 596 are1.3mg/kg, 2.6mg/kg, 5.2 mg/kg and
7.0mg/kg Q BIW. Doses may be de-escalated for management of toxicity with the lowest dose
being 0.65 mg/kg. A total of 3 cycles of PTC596 and paclitaxel/ carboplatin will be given
before iCRS and an additional 3-5 cycles following iCRS.

Inclusion Criteria:

- Histologically documented epithelial ovarian, primary peritoneal or fallopian tube
carcinoma or high grade serous adenocarcinoma, endometrioid adenocarcinoma,
undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or
adenocarcinoma not otherwise specified (N.O.S.).

- Newly diagnosed and be previously untreated. Adequate bone marrow function, renal
function and hepatic function. Neuropathy (sensory and motor) less than or equal to
Grade 1.

- No active infection requiring parenteral antibiotics or a serious uncontrolled medical
illness or disorder within four weeks of study entry.

- Hormonal therapy directed at the malignant tumor must be discontinued at least one
week prior to registration. Continuation of hormone replacement therapy is permitted.

- Performance status score of 0, 1, or 2 by Eastern Cooperative Group (ECOG) criteria.

- Patients of childbearing potential must have a negative pregnancy test prior to the
study entry and be practicing an effective form of contraception.

Exclusion Criteria:

- Prior treatment with PTC596 or standard of care drugs (cis- or carboplatin or
paclitaxel.

- Use of an investigational drug within 4 weeks of dosing in the current study.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to PTC596 or other agents used in this study.

- Have a clinical requirement for ongoing systemic immunosuppressive therapy such as
chronic steroid use not related to chemotherapy administration.

- Receiving treatment for active autoimmune disease. History of other invasive
malignancies, with the exception of non-melanoma skin cancer and other specific
malignancies within the last three years.

- Prior radiotherapy to any portion of the abdominal cavity or pelvis.

- Prior chemotherapy for any abdominal or pelvic tumor. Known active hepatitis.

- Have concurrent severe medical problems unrelated to the malignancy that would
significantly limit full compliance with the study.

- Have childbearing potential but not practicing adequate contraception.

- History or active CNS disease.

- Concomitant therapy with any of the following: other non-study cytotoxic chemotherapy;
other investigational therapies.

- Presence or history of moderate to severe pulmonary dysfunction.