US2021052622A1PendingUtilityA1

Defibrotide for use in prophylaxis and/or treatment of graft versus host disease (gvhd)

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Assignee: GENTIUM S R LPriority: Nov 12, 2010Filed: Jul 29, 2020Published: Feb 25, 2021
Est. expiryNov 12, 2030(~4.3 yrs left)· nominal 20-yr term from priority
Inventors:Massimo Iacobelli
C12N 15/111C12N 15/11A61K 31/7088A61K 31/711A61P 43/00A61K 9/08A61P 37/06A61K 9/0019
71
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Claims

Abstract

Defibrotide for use in prophylaxis and/or treatment of Graft versus Host Disease (GVHD) in humans is disclosed, preferably in hematopoietic stem cell transplantation (HSCT), more preferably allogeneic hematopoietic stem cell transplantation. Graft versus Host Disease of the invention (GVHD) can be acute aGVHD and/or chronic cGVHD, preferably acute.

Claims

exact text as granted — not AI-modified
1 . A method of preventing Veno-Occlusive Disease (VOD) comprising administering to a patient at risk of VOD an amount of defibrotide sufficient to reduce the occurrence or severity of VOD. 
     
     
         2 . The method of  claim 1 , wherein heparin or other antithrombotics are not administered to the patient. 
     
     
         3 . The method of  claim 1 , wherein the VOD is hepatic VOD. 
     
     
         4 . The method of  claim 1 , wherein the patient is a pediatric patient. 
     
     
         5 . The method of  claim 1 , wherein the administration of defibrotide occurs before the patient is subjected to hematopoietic stem cell transplantation (HSCT). 
     
     
         6 . The method of  claim 1 , wherein the administration of defibrotide occurs on the first day of a pre-transplant conditioning regimen. 
     
     
         7 . The method of  claim 1 , wherein the administration of defibrotide starts on the same day as a pre-transplant conditioning regimen. 
     
     
         8 . The method of  claim 1 , wherein the administration of defibrotide continues for at least 14 days. 
     
     
         9 . The method of  claim 8 , wherein the administration of defibrotide continues for at least 23 days. 
     
     
         10 . The method of  claim 9 , wherein the administration of defibrotide continues for at least 30 days. 
     
     
         11 . The method of  claim 3 , wherein the HSCT is an allogenic hematopoietic stem cell transplantation. 
     
     
         12 . The method of  claim 1 , wherein the defibrotide is administered in a dose ranging from 10 to 60 mg/kg/day. 
     
     
         13 . The method of  claim 12 , wherein the defibrotide is administered in a dose ranging from 20 to 40 mg/kg/day. 
     
     
         14 . The method of  claim 13 , wherein the defibrotide is administered in a dose of about 25 mg/kg/day. 
     
     
         15 . The method of  claim 1 , wherein the defibrotide is administered in a single dose. 
     
     
         16 . The method of  claim 1 , wherein the defibrotide is administered in repeated doses per day. 
     
     
         17 . The method of  claim 16 , wherein the defibrotide is administered in four doses per day. 
     
     
         18 . The method of  claim 1 , wherein the defibrotide is administered intravenously. 
     
     
         19 . The method of  claim 1 , wherein the defibrotide is administered in aqueous form. 
     
     
         20 . The method of  claim 1 , wherein the defibrotide was obtained by extraction from animal tissues. 
     
     
         21 . The method of  claim 20 , wherein the defibrotide was obtained by extraction from mammalian organs. 
     
     
         22 . The method of  claim 1 , wherein the patient is monitored at least weekly post-HSCT transplant. 
     
     
         23 . The method of  claim 22 , wherein the patient's bilirubin levels are measured. 
     
     
         24 . The method of  claim 22 , wherein the patient's abdominal ultrasound is measured.

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