Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer

Numerous studies in pre-clinical models and in human clinical trials have clearly
established the potential for the use of rexinoids in the treatment and prevention of
cancer. NRX 194204, a second generation rexinoid, is a highly potent and specific activator
of RXRs. Because NRX 194204 is significantly more selective for the RXRs relative to the
RARs than a first generation approved drug, it is associated with fewer adverse events in
clinical use. This study seeks to investigate NRX 194204 monotherapy in patients with
castration- and taxane- resitant prostate cancer.

Inclusion Criteria:

- Histologically or cytologically confirmed prostate cancer

- Documented progression on at least one prior hormone treatment, AND at least one
taxane based chemotherapy regimen, or patient's refusal of chemotherapy treatment

- Male, Age > 18 years

- ECOG performance score of 0-2

- Adequate bone marrow, renal and hepatic function

- Men of childbearing potential must consent to use barrier contraception while on
treatment and for 90 days thereafter

Exclusion Criteria:

- Prior treatment with NRX 194204 or bexarotene (Targretin)

- Presence of parenchymal brain metastases

- History of prior malignancy within the past 5 years with the exception of curatively
treated basal cell or squamous cell carcinoma of the skin or superficial bladder or
other stage I or stage II cancer in complete remission for at least 12 months

- Patients with a history of unstable or newly diagnosed angina pectoris, documented
history of current serious arrhythmia or congestive heart failure or myocardial
infarction within 6 months of enrollment

- Known HIV or hepatitis B or C infection

- Life expectancy < 3 months

- Patients with any history of thyroid disease, pituitary disease or treatment with
thyroid replacement hormone

- Patients with a history of pancreatitis or at significant risk of developing
pancreatitis