An Open-Label, Phase I Dose Escalation Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer

Inclusion Criteria:

- Signed Informed Consent

- Men, 18 - 75 years of age

- Documented prostate cancer with a rising PSA post androgen suppression or blockade
therapy

- Chemotherapy naïve

- ECOG Performance Score of 0,1, or 2

- Life expectancy ≥ 1 year

- No significant cardiac, bone marrow, hepatic, or renal dysfunction; or coagulopathy
(defined as no AE ≥ Grade 3 according to NCI CTCAE v 3.0). Patients with a known
history of a CLINICALLY NON-SIGNIFICANT laboratory parameter may be eligible for
inclusion provided an exemption is granted by the study Medical Monitor prior to
enrollment.

- A negative virology screen for HIV, hepatitis B surface antigen, and hepatitis C

Exclusion Criteria:

- Metastatic disease

- Congestive heart failure (NYHA Class III or IV), unstable angina, or cardiovascular
disease such as stroke or myocardial infarction (current or within the past 6 months)

- History of prior malignancies other than prostate cancer within the past 5 years,
excluding basal or squamous cell carcinoma of the skin

- Known allergy to eggs, egg products, or aminoglycoside antibiotics, e.g., gentamicin
or tobramycin

- Chronic administration (defined as 5 or more days of consecutive use) of systemic
corticosteroids within 14 days of the first planned dose of MVA-BN®-PRO. Use of
inhaled steroids, nasal sprays, eye drops and topical creams for small body areas is
allowed.

- History of or active autoimmune disease. Persons with vitiligo or thyroid disease
taking thyroid replacement hormones are not excluded.

- Prior solid organ or hematopoietic allogenic transplant(s)

- Receipt of an investigational agent within 28 days of the first planned dose of
MVA-BN®-PRO

- Prior "vaccine" therapy for prostate cancer at any time

- Vaccination: Live (attenuated) vaccine (e.g., FluMist®). Vaccination with a live
vaccine within 28 days of the first planned dose of MVA-BN®-PRO, or plans to receive
a live vaccine within 28 days after the last dose of MVA-BN®-PRO is not allowed

- Vaccination: Killed (inactivated) vaccine (e.g., PneumoVax®). Vaccination with a
killed vaccine within 14 days of the first planned dose of MVA-BN®-PRO, or plans to
receive a killed vaccine within 14 days after the last dose of MVA-BN®-PRO is not
allowed.

- Radiation therapy within 28 days of the first planned dose of MVA-BN®-PRO or plans
for radiation therapy during treatment or re-treatment. Prior to initiating
palliative radiation during the (re)treatment phase of the study, the Sponsor's
medical monitor or designee must be notified.

- Any condition which, in the opinion of the investigator, would prevent full
participation in this trial (including the long-term follow-up), or would interfere
with the evaluation of the trial endpoints

- Study personnel