At Gentium, we are dedicated to advancing the care of patients suffering from life-threatening diseases. The following list is designed to provide up-to-date information on our on-going clinical studies. Research and development programs are focused to treat and prevent a variety of vascular diseases and conditions related to cancer and cancer treatments.
Gentium’s lead compound, Defibrotide, has been studied in number of indications and is currently in various stages of clinical development. In addition, two groups of compounds are currently in pre-clinical stages of development.
| Candidate | Indication | Phase | Status | |
| Defibrotide |
Treatment of Severe Veno Occlusive Disease |
Pivotal Phase III |
completed |
Historically controlled, multicenter, open label Phase III clinical trial to determine the safety and efficacy of 25 mg/kg/day of Defibrotide for the treatment of severe VOD in hematopoietic SCT patients. |
| |
Prevention of Veno Occlusive Disease |
Pivotal Phase II/III |
completed |
Multi-center, open label, randomized clinical trial to evaluate the prophylactic use of Defibrotide in pediatric patients undergoing stem cell transplantation who are at high risk for hepatic Veno-Occlusive Disease (VOD). |
| |
Treatment IND |
|
active |
This study is recruiting in the U.S. |
| |
Treatment of Multiple Myeloma |
Phase I/II |
completed |
Dose-escalating, multi center, non comparative, open label Phase I/II clinical studies of Defibrotide to treat multiple myeloma in combination with melphalan, prednisone, and thalidomide. |
| Oligotide |
Multiple |
Pre-Clinical |
exploratory |
|
| Nmers |
Multiple |
Pre-Clinical |
exploratory |
|
|---|
Download file "Gentium pipeline PDF"