An Evaluation of Tc 99m Tilmanocept by Intravenous (IV) and Subcutaneous (SC) Injection in Kaposi Sarcoma (KS)

This is a prospective, single-center, open-label, non-randomized, dose escalation,
comparative, safety study of intravenously and subcutaneously injected Tc 99m tilmanocept in
the localization and detection of cutaneous and non-cutaneous KS tumor(s) in subjects with
biopsy-confirmed KS. Three IV doses (µg/mCi) of tilmanocept will be evaluated in three cohort
groups. One subcutaneous dose will be evaluated in cohort group 3.

This study is designed to evaluate the safety and tolerability of escalating doses of IV Tc
99m tilmanocept and to compare results obtained from IV and subcutaneous administrations of
Tc 99m tilmanocept in the same subjects. Whole body planar as well as SPECT/CT imaging will
be performed to provide greater resolution of areas of Tc 99m tilmanocept localization. A
biopsy of a non-visceral KS lesion will be taken to correlate pathology with Tc 99m
tilmanocept localization.

This study is designed to evaluate the use of Tc 99m tilmanocept as an imaging agent in
HIV-positive subjects with known KS by evaluating localization in known and unknown cutaneous
and non-cutaneous lesions.

Inclusion Criteria:

1. The subject has provided written informed consent with HIPAA authorization before the
initiation of any study-related procedures.

2. The subject is at least 18 years of age at the time of consent.

3. The subject is HIV positive.

4. The subject has a biopsy-confirmed diagnosis of KS and is classified into one of the
categories below:

1. Confirmed cutaneous KS/oral lesions without edema.

2. Confirmed cutaneous KS/oral lesions with edema.

3. Confirmed cutaneous KS/oral lesions with or without edema and suspected
non-cutaneous KS due to clinical symptomology or confirmed non-cutaneous KS
lesion(s).

Exclusion Criteria:

1. The subject is pregnant or lactating.

2. The subject has received chemotherapy or radiation therapy to KS sites within six
weeks of enrollment.

3. The subject has known sensitivity to dextran.

4. The subject has received an investigational product within 30 days prior to the Tc 99m
tilmanocept administration on Day 1.

5. The subject has received any radiopharmaceutical within 7 days prior to the
administration of Tc 99m tilmanocept on Day 1.

6. Any condition that, in the clinical judgment of the treating physician, is likely to
prevent the subject from complying with any aspect of the protocol or that may put the
subject at unacceptable risk.