公开(公告)号：US20230084937A1

公开(公告)日：2023-03-16

申请号：US17883452

申请日：2022-08-08

Applicant: Gentium S.R.L.

Inventor： Massimo IACOBELLI

IPC: A61K31/711 ,  A61P1/16 ,  A61K9/00

Abstract: In various embodiments, the present disclosure teaches methods of treating patients diagnosed as having sinusoidal obstruction syndrome with defibrotide.

公开(公告)号：US20190328765A1

公开(公告)日：2019-10-31

申请号：US16398978

申请日：2019-04-30

Applicant: GENTIUM S.R.L.

Inventor： Massimo IACOBELLI

IPC: A61K31/711 ,  A61K9/00 ,  A61P1/16

Abstract: In various embodiments, the present disclosure teaches methods of treating patients diagnosed as having sinusoidal obstruction syndrome with defibrotide.

公开(公告)号：US20170080012A1

公开(公告)日：2017-03-23

申请号：US15366213

申请日：2016-12-01

Applicant: GENTIUM S.R.L.

Inventor： Massimo IACOBELLI

IPC: A61K31/711 ,  A61K9/08 ,  A61K9/00

CPC classification number: A61K31/711 ,  A61K9/0019 ,  A61K9/08 ,  A61K31/7088 ,  C12N15/11 ,  C12N15/111

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.

公开(公告)号：US20210363519A1

公开(公告)日：2021-11-25

申请号：US17396028

申请日：2021-08-06

Applicant: GENTIUM S.R.L.

Inventor： Terenzio IGNONI ,  Vijay KUMAR ,  Khalid ISLAM

IPC: C12N15/11 ,  A61K31/711 ,  C12Q1/37 ,  C12Q1/56 ,  G01N33/86

Abstract: It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27 to 32 IU/mg and, more preferably, from 28 to 32 IU/mg.

公开(公告)号：US11085043B2

公开(公告)日：2021-08-10

申请号：US16816741

申请日：2020-03-12

Applicant: GENTIUM S.R.L.

Inventor： Terenzio Ignoni ,  Vijay Kumar ,  Khalid Islam

IPC: C12N15/11 ,  C12N9/68 ,  A61K31/711 ,  A61K38/36 ,  C12Q1/37 ,  C12Q1/56 ,  G01N33/86

Abstract: It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27 to 32 IU/mg and, more preferably, from 28 to 32 IU/mg.

公开(公告)号：US20210052622A1

公开(公告)日：2021-02-25

申请号：US16942328

申请日：2020-07-29

Applicant: GENTIUM S.R.L.

Inventor： Massimo IACOBELLI

IPC: A61K31/711 ,  C12N15/11 ,  A61K31/7088 ,  A61K9/00 ,  A61K9/08

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.

公开(公告)号：US20200208148A1

公开(公告)日：2020-07-02

申请号：US16816741

申请日：2020-03-12

Applicant: GENTIUM S.R.L.

Inventor： Terenzio IGNONI ,  Vijay KUMAR ,  Khalid ISLAM

IPC: C12N15/11 ,  G01N33/86 ,  C12Q1/56 ,  C12Q1/37 ,  A61K31/711

Abstract: It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27 to 32 IU/mg and, more preferably, from 28 to 32 IU/mg.

公开(公告)号：US20250075206A1

公开(公告)日：2025-03-06

申请号：US18953184

申请日：2024-11-20

Applicant: GENTIUM S.R.L.

Inventor： Terenzio IGNONI ,  Vijay KUMAR ,  Khalid ISLAM

IPC: C12N15/11 ,  A61K31/711 ,  C12Q1/37 ,  C12Q1/56 ,  G01N33/86

Abstract: It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27 to 32 IU/mg and, more preferably, from 28 to 32 IU/mg.

公开(公告)号：US20170322199A1

公开(公告)日：2017-11-09

申请号：US15529814

申请日：2015-11-23

Applicant: GENTIUM S.R.L.

Inventor： Terenzio IGNONI ,  Vijay KUMAR ,  Claudio VERGA

IPC: G01N33/50

CPC classification number: G01N33/5014 ,  G01N33/5064

Abstract: The present invention relates to cell-based methods for determining the biological activity of defibrotide. In particular, the invention provides a method for assessing the potency of defibrotide by assessing the viability of mammalian cells in the presence of at least one cytotoxic agent and one or more concentrations of defibrotide. Such methods are particularly useful for standardizing pharmaceutical compositions comprising defibrotide.

公开(公告)号：US20170304349A1

公开(公告)日：2017-10-26

申请号：US15645330

申请日：2017-07-10

Applicant: GENTIUM S.R.L.

Inventor： Massimo IACOBELLI

IPC: A61K31/711 ,  A61K31/7088 ,  A61K9/00 ,  A61K9/08 ,  C12N15/11

CPC classification number: A61K31/711 ,  A61K9/0019 ,  A61K9/08 ,  A61K31/7088 ,  C12N15/11 ,  C12N15/111

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 (IISCT), more preferably allogeneic hernatopoietic stein cell transplantation. Graft versus Host Disease oldie invention (GVHD) can be acute aGVHD and/or chronic cOVHD, preferably acute.