Phase 2 Trial of Maintenance Vigil for High Risk Stage IIIb-IV Ovarian Cancer

This is a multicenter, randomized, double-blind, placebo-controlled, Phase 2 study of
maintenance Vigil Ovarian (gemogenovatucel-T) engineered autologous tumor cells (EATC) in
women with Stage IIIb, IIIc or IV high-grade papillary serous/ clear cell / endometrioid
ovarian, fallopian tube or primary peritoneal cancer. Subjects will have had a minimum of 4
and a maximum of 12 doses of Vigil prepared and stored from ovarian tumor cells obtained at
the time of primary surgical debulking or initial diagnostic / evaluative laparoscopy (tissue
for immunotherapy manufacture must be procured prior to initiation of neoadjuvant
chemotherapy). An equal number of placebo doses will be manufactured. Subjects will have
achieved a clinically defined complete response following primary surgery and adjuvant
chemotherapy.

Investigational treatment must start no less than 3 weeks and no more than 8 weeks following
completion of chemotherapy.

Approximately 86 subjects will be randomized 1:1 to receive either monthly intradermal Vigil
or placebo for at least 4 to a maximum of 12 administrations. Randomization will be
stratified by (i) extent of surgical cytoreduction (complete/microscopic versus macroscopic
residual disease) and (ii) neoadjuvant versus adjuvant chemotherapy. The objective is
determining RFS of subjects randomized to Vigil versus placebo.

Inclusion Criteria

Subjects will be eligible for tissue procurement for the Vigil manufacturing process if
they meet all of the following criteria:

1. Presumptive Stage IIIb, IIIc or IV high-grade papillary serous/clear cell/endometrioid
ovarian, fallopian tube or primary peritoneal cancer.

2. No chemotherapy prior or investigational agents prior to tissue acquisition for Vigil
manufacture.

3. No other malignancy (excluding surgically cured nonmelanoma carcinomas of the skin and
carcinoma in situ cervix) unless in remission for ≥ 2 years.

4. Anticipated availability of a cumulative mass of ~30 grams tissue ("golf-ball" size or
approximately 3cm disease on CT scan) at time of diagnostic laparoscopy or primary
surgical debulking. Infiltrating lumen (bowel, fallopian tube, urethra) tissue should
not be used as Vigil immunotherapy material to minimize risk of bacterial
contamination.

5. ECOG performance status (PS) 0-2 prior to diagnostic laparoscopy or debulking
laparotomy.

6. No prior history of hypersensitivity reactions (HSR) with taxanes or platinums.

7. No prior history of allergies or sensitivities to gentamicin.

8. Female, 18 years of age or older.

9. Ability to understand and the willingness to sign a written informed consent document
for tissue harvest.

Subjects will be registered in this study if they meet all of the following inclusion
criteria:

1. Histologically confirmed Stage IIIb, IIIc or IV high-grade papillary serous/clear
cell/endometrioid ovarian, fallopian tube or primary peritoneal.

2. Completion of primary surgical debulking including hysterectomy and bilateral salpingo
oophorectomy, and at least 5 but no more than 8 cycles of platinum / taxane adjuvant
chemotherapy or chemotherapy as per Category 1 recommendations of the NCCN guidelines,
including 5-8 cycles adjuvant intraperitoneal + intravenous (IP/IV) chemotherapy, or
5-8 cycles of intravenous chemotherapy divided and administered as neoadjuvant and
adjuvant therapy flanking primary debulking surgery.

3. Clinically defined complete response (cCR) following completion of primary surgical
debulking and eligible chemotherapy. cCR defined as no evidence of malignancy on chest
x-ray (CT scan is acceptable) and CT scan or MRI of the abdomen and pelvis, normal
physical examination, CA-125 antigen level ≤ 35 U/ml (assessed ≥ 2 weeks following
removal of catheter in subjects receiving intraperitoneal/intravenous chemotherapy)
and no findings on physical examination or symptoms suggestive of active cancer.

4. Subjects must have initiated adjuvant chemotherapy no more than 8 weeks following
primary debulking surgery.

5. Successful manufacturing of at least 4 doses (vials) of Vigil and placebo.

6. Recovered from all clinically relevant toxicities related to prior therapy (including
neuropathy ≤Grade 2).

7. ECOG performance status (PS) 0-1.

8. Normal organ and marrow function as defined below: Absolute granulocyte count ≥
1,500/mm^3, Absolute lymphocyte count ≥ 500/mm^3, Platelets ≥ 75,000/mm^3, Total
bilirubin ≤ 2 mg/dL, AST(SGOT)/ALT(SGPT)≤ 2x institutional upper limit of normal,
Creatinine < 1.5 mg/dL

9. Ability to understand and the willingness to sign a written informed protocol specific
consent.

Exclusion Criteria:

Subjects will be excluded from this study if they meet any of the following criteria (at
the time of tissue procurement or at randomization):

1. Surgery involving general anesthesia, radiotherapy, immunotherapy, or investigational
agents within 4 weeks prior to randomization.

2. Histologically confirmed papillary serous adenocarcinoma of the uterus or disease
involving myometrium/endometrium.

3. Systemic immunosuppressive therapy within 14 days of randomization.

4. Subjects requiring chronic steroid or immunosuppressive regimens are excluded except
inhaled / intranasal steroids and short term systemic steroids <30 days duration and
≤0.25 mg/kg prednisone-equivalent per day are allowed.

5. Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or
hemodynamically significant atrial arrhythmia, or cardiovascular disease such as
stroke or myocardial infarction (current or within the past 6 months).

6. Psychiatric illness/social situations that would limit compliance with study
requirements.

7. Subjects with history of brain metastases.

8. Subjects with known HIV or chronic Hepatitis B or C infection.

9. Prior solid organ or bone marrow transplant.

10. History of or active autoimmune disease (e.g., autoimmune neutropenia,
thrombocytopenia, or hemolytic anemia, systemic lupus erythematosus, Sjogren's
syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome, Addison's disease,
Hashimoto's thyroiditis, or Graves disease). Persons with vitiligo are not excluded.
Diabetics are not excluded if the condition is well controlled.