A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection

Inclusion Criteria:

• Male or female, aged 2 months and older at the time of informed consent.

• AdV DNA viremia >10,000 copies/mL from a single sample, or 2 samples greater than 48hours apart with the second result higher than the first and both greater than 1000copies/mL, from the data obtained from the designated central virology laboratory ofthe local laboratory using the blood sample(s) collected informed consent has beenobtained and within 7 days prior to Day 1 (AdV DNA viremia results collected withinthe 7 day window, but prior to consent may be used if the Informed Consent Form (ICF) signed by the subject provides approval) . CMV viremia with or withoutevidence of tissue invasive CMV disease. For laboratory results that are generatedin units other than copies/mL or IU/mL, please refer to the testing laboratory forguidance on the appropriate conversion calculation.

• Either (a) have disseminated AdV disease or (b) have an underlying immunocompromisedstate, and have asymptomatic AdV infection or localized AdV disease.

• In the judgment of the investigator, be in a serious condition to be treated withintravenous cidofovir for AdV.

Exclusion Criteria:

• Subjects who weigh ≥120 kg.

• NIH/NCI CTCAE (United States [US] National Institutes of Health [NIH]/NationalCancer Institute) Grade 2 or higher diarrhea (i.e., increase of ≥ 4 stools per dayover usual pre-transplant stool output) within 7 days prior to Day 1.

• NIH Stage 4 acute GVHD of the skin (i.e., generalized erythroderma with bullousformation) within 7 days prior to Day 1.

• NIH Stage 2 or higher acute GVHD of the liver function (i.e., bilirubin >3 mg/dL [SI: >51 μmol/L]) within 7 days prior to Day 1.

• NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea >556 mL/m2/day forpediatric subjects [or >1000 mL/day for young adults as applicable, at centers inthe United States only], or severe abdominal pain with or without ileus) within 7days prior to Day 1.