Efficacy and Safety Study of CSJ148 in Stem Cell Transplant Patients

This study is randomized, double-blinded, and placebo-controlled. 80 Patients will be
enrolled and randomized to CSJ148 and placebo in a ratio of 3:1. Patients undergoing stem
cell transplantation will be enrolled into the study. The study will consist of a screening
period, a baseline visit, approximately 3-month treatment exposure period, an end-of-therapy
visit, a follow-up period, and a study completion evaluation approximately 3.5 months after
the last dose of study drug is administered.

Inclusion Criteria:

- Male and female patients at least 18 years of age scheduled to undergo allogeneic bone
marrow, peripheral blood stem cell, or cord blood transplantation and begin
conditioning chemotherapy within 24-48 hours of planned dosing day.

- Subject seropositive for HCMV before transplantation; donor can be seropositive or
seronegative for HCMV (donor positive/recipient positive or donor negative/recipient
positive).

Exclusion Criteria:

- Have had HCMV-related organ disease within 6 months prior to enrollment.

- Detectable HCMV infection (positive pp65 antigenemia or plasma HCMV DNA polymerase
chain reaction (PCR) assays prior to enrollment

- Received any of the following within 30 days prior to enrollment: ganciclovir,
valganciclovir, foscarnet, cidofovir, acyclovir (>25 mg/kg/day IV), valacyclovir (>3
gm/day oral), famciclovir (>1500 mg/day oral), HCMV immune globulin, immune globulin
(>500 mg/kg), or any other medication with anti-HCMV activity.

- Require mechanical ventilation within 7 days prior to enrollment.

- Received any vasopressors or other agents for hemodynamic support within 7 days prior
to enrollment.

- Impaired renal function requiring dialysis.