Delving into the Latest Updates on Human Plasma Derived Antithrombin(Octapharma) with Synapse

Overview

Basic Info

Drug Type

Enzyme

Synonyms

Atenativ

Target-

Mechanism-

Therapeutic Areas

Congenital DisordersHemic and Lymphatic Diseases

Active Indication

Antithrombin III Deficiency

Inactive Indication-

Originator Organization

Octapharma AG

Active Organization

Octapharma AG

Georgetown University School of Medicine

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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In Japan, the dose of the new recombinant antithrombin III concentrate (rAT-gamma) is titrated according to patient body weight (BW), while conventional plasma-derived antithrombin concentrates (AT) are administered as a fixed dose. Therefore, it is anticipated that rAT-gamma could produce better treatment effects than AT. The aim of this study was to compare the organ protective effects of doses of rAT-gamma and AT administered in clinical practice for septic disseminated intravascular coagulation (DIC) and multiple organ failure. This study was performed at a single university hospital in Japan. A total of 49 patients with antithrombin deficiency secondary to septic DIC who were administered either rAT-gamma (n = 26) or AT (n = 23) were retrospectively analyzed to assess the dose of supplemental antithrombin concentrates, plasma antithrombin activity, Japanese Association for Acute Medicine (JAAM)-DIC score, and modified Sequential Organ Failure Assessment (SOFA) score on days 0, 3 and 6. The AT-equivalent dose per kg BW of rAT-gamma (equal to the initial rAT-gamma dose per kg BW divided by 1.2) was significantly higher than the dose per kg BW of AT (AT 23.4 ± 5.1 vs. rAT 28.9 ± 3.9 IU/kg/day; P < 0.001). Consequently, serial increases in plasma antithrombin levels occurred more rapidly in the rAT-gamma group (P = 0.036). JAAM DIC and modified SOFA scores revealed significantly greater improvement in the rAT versus the AT group (JAAM DIC score: P = 0.042, mSOFA score: P = 0.005). The results of this study suggest that AT supplementation adjusted for patient BW might further improve septic DIC and multiple organ failure.

01 May 2018·International Journal of HematologyQ4 · MEDICINE

Protective effect of a newly developed fucose-deficient recombinant antithrombin against histone-induced endothelial damage

Q4 · MEDICINE

Article

Author: Nagaoka, Isao ; Hirota, Tatsuhiko ; Iba, Toshiaki ; Sato, Koichi

Antithrombin is expected to modulate both prothrombotic and proinflammatory reactions in sepsis; vascular endothelium is the primary target. In the present study, we sought to evaluate the protective effects of a newly developed fucose-deficient recombinant antithrombin. Endothelial cells were treated in vitro with histone H4 to induce cellular damage. Low to high doses of either plasma-derived antithrombin or recombinant thrombomodulin were used as treatment interventions. Morphological change, apoptotic rate, cell viability, cell injury, and syndecan-4 level in the medium were evaluated. Immunofluorescent staining with anti-syndecan-4 was also performed. Both types of antithrombin reduced cellular damage and apoptotic cell death. Both plasma-derived and recombinant antithrombin improved cell viability and reduced cellular injury when administered at a physiological concentration or higher. Syndecan-4 staining became evident after treatment with histone H4, and both antithrombins suppressed the staining intensity at similar levels. The syndecan-4 level in the medium was significantly decreased by both antithrombins. None of the indicators showed a significant difference between plasma-derived and recombinant antithrombin. In conclusion, both recombinant and plasma-derived antithrombin can protect vascular endothelial cells. Recombinant antithrombin may represent a useful new therapeutic agent for sepsis-associated vascular damage.

01 Aug 2007·Antiviral ResearchQ2 · MEDICINE

Human monoclonal antibody against Hepatitis B virus surface antigen (HBsAg)

Q2 · MEDICINE

Article

Author: Pan-Kyung Kim ; Jin-Seol Choi ; Ki-Tae Bong ; Minyoung So ; Jie-Young Park ; Se-Ho Kim ; Kyung-Hwan Ryoo ; Ki-Hwan Chang ; Kwang-Won Hong ; Yong-Won Shin

Hepatitis B virus (HBV) is one of the main pathogens responsible for hepatitis and hepatocellular carcinoma. Human plasma-derived Hepatitis B immune globulin (HBIG) is being used for prophylactic and liver transplantation currently. However, it may be necessary to replace a HBIG with a recombinant one because of limited availability of human plasma with high anti-HBsAg antibody titer and possible contamination of human pathogens. A Chinese hamster ovary (CHO) cell line, HB-C7A, was established which produces a fully human IgG1 that binds HBsAg. The HB-C7A exhibits approximately 2600 units/mg of antibody. The affinity (K(a)) of HB-C7A is 1.1 x 10(8) M(-1) by Biacore analysis and estimated 6.7-fold higher than that of Hepabig (a plasma-derived HBIG from Green Cross Corp., Yongin, Korea) by competition ELISA. The HB-C7A recognizes the conformational "a" determinant of HBsAg and binds HBV particle more efficiently than the Hepabig. The HB-C7A binds to HBV-infected human liver tissue but does not bind to normal human tissues. This HB-C7A has several advantages compared to plasma-derived Hepabig such as activity, safety and availability.

100 Deals associated with Human Plasma Derived Antithrombin(Octapharma)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Antithrombin III Deficiency	Phase 3	ES	Octapharma AG	01 Jul 2022
Antithrombin III Deficiency	Phase 3	HU	Octapharma AG	01 Jul 2022
Antithrombin III Deficiency	Phase 3	IT	Octapharma AG	01 Jul 2022
Antithrombin III Deficiency	Phase 3	DE	Octapharma AG	01 Jul 2022
Antithrombin III Deficiency	Phase 3	US	Octapharma AG	01 Jul 2022
Antithrombin III Deficiency	Phase 3	FR	Octapharma AG	01 Jul 2022
Antithrombin III Deficiency	Phase 3	IL	Octapharma AG	01 Jul 2022
Antithrombin III Deficiency	Phase 3	AT	Octapharma AG	01 Jul 2022
Antithrombin III Deficiency	Phase 3	GB	Octapharma AG	01 Jul 2022
Antithrombin III Deficiency	Phase 3	RS	Octapharma AG	01 Jul 2022