Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)

Inclusion Criteria:

- Receipt of allogeneic hematopoietic cell transplant >100 days prior to consent

- Documented cGVHD as defined by the NIH consensus criteria in at least one organ system
other than the GI tract (for example, cGVHD of the oral cavity would qualify as a
criterion)

- Endoscopic findings consistent with GI GVHD

- Must be able to swallow tablets

- Must be able to read and understand informed consent

- Adequate birth control methods for the duration of the study

Exclusion Criteria:

- >500 mL/day of diarrhea on any 1 day within 3 days prior to the first dose of study
drug

- GI infection

- Multi-organ failure or other condition that, in the opinion of the investigator, would
compromise the patient's ability to complete the study.

- HIV seropositivity

- Pregnant or nursing female

- Use of any investigational drug to treat chronic GVHD within 28 days of the first dose
of study drug

- Evidence of recurrent or progressing malignant disorder that was the indication for
HCT