Expanded Access Program of Ultratrace Iobenguane I131 for Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma

MIP-IB12B, the pivotal phase 2 study evaluating efficacy and safety of AZEDRA in patients
with malignant relapsed/refractory PPGL, has completed its anticipated enrollment. The
purpose of this sub-study, MIP-IB12B-EAP, is to provide expanded access to AZEDRA for newly
enrolled subjects with iobenguane-avid metastatic and/or recurrent PPGL and to collect
additional safety data.

Inclusion Criteria:

- Able and willing to provide informed consent/assent and comply with protocol
requirements

- Documented diagnosis of either pheochromocytoma or paraganglioma that was confirmed by
histology or other supportive data (e.g. abnormal MIBG diagnostic study or elevated
tumor markers)

- Ineligible for curative surgery for PPGL

- Failed a prior therapy for PPGL or have no alternative indicated therapy available

- Have definitive tumor avidity confirmed by the AZEDRA dosimetry dose

- Life expectancy of at least 6 months per physician

Exclusion Criteria:

- Pregnant or nursing females

- Men or women of childbearing potential and unwilling to use a medically acceptable
form of contraception from time of consent until 6 months following last therapeutic
dose of AZEDRA

- Active CNS lesions by CT/MRI within 3 months of informed consent

- NYHA class IV heart failure, unstable angina pectoris or clinically significant
cardiac arrhythmia that poses a risk of syncope or cardiac arrest

- Prior systemic radiotherapy resulting in marrow toxicity within 3 months of first
AZEDRA therapeutic dose

- Prior iobenguane I 131 therapeutic exposure within 12 weeks of the first planned
therapeutic dose

- Prior administration of whole-body radiation therapy within 12 weeks of the first
planned therapeutic dose

- Prior external beam radiotherapy to > 25% of bone marrow

- Prior chemotherapy or investigational compound and/or device within 30 days of the
dosimetry dose

- Other active malignancy requiring additional treatment except for superficial
cutaneous neoplasms

- Karnofsky Performance Status < 60

- Clinically significant laboratory abnormalities prior to dosing as listed in the
protocol (such as blood count abnormalities, liver enzyme abnormalities, and renal
dysfunction)

- Medical history of AIDS/HIV+

- Active chronic alcohol abuse, chronic liver disease (not including liver metastases),
hepatitis A, B, or C

- Known allergy to iobenguane that has required medical intervention

- Receiving a medication which inhibits tumor uptake of iobenguane I 131

- Any other condition, that in the opinion of the investigator, may compromise the
safety or compliance of the subject