A Phase II Trial of SGN-00101 In The Treatment of Pediatric Recurrent Respiratory Papillomatosis

Inclusion Criteria:

- Male or female between 2 and 18 yrs old, inclusive, who has documented RRP.

- Patients with documented RRP

- Subject is surgically debulked within 7 days before the first dose of SGN-00101.

- Subject has had at least 4 debulking surgeries for RRP, had no intersurgical
intervals greater than 84 days during the period of the last 4 surgeries.

- Subject is free of life threatening or serious concomitant disorders other than the
disease under study.

- Females of childbearing potential must have a negative pregnancy test and must be
practicing an effective/appropriate method of birth control as determined by the
Investigator.

Exclusion Criteria:

- Subject has disease or status that causes compromise of the immune system.

- Subject has a history of ionizing radiation therapy to the respiratory tract.

- Patient has used concomitant medications that may suppress the immune system.

- Subject has received any specific or non-specific immunotherapy intended as treatment
for their RRP (i.e. mumps vaccine injected intralesionally) within 9 months prior to
Week 0 of this study.

- Subject has participated in a past study with SGN-00101

- Pregnancy and lactation.