Delving into the Latest Updates on DF-004 with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

DF 004

Target

OX40

Mechanism

OX40 inhibitors(Tumor necrosis factor receptor superfamily member 4 inhibitors)

Therapeutic Areas

Digestive System Disorders

Active Indication

Colitis

Inactive Indication-

Originator Organization

Shanghai Drug Farm Biological Technology Co., Ltd.Startup

Active Organization

Shanghai Drug Farm Biological Technology Co., Ltd.Startup

Inactive Organization-

Drug Highest PhaseDiscovery

First Approval Date-

Regulation-

Implantable cardioverter defibrillator (ICD) technology has evolved from the surgical thoracotomy based device systems in 1980 to only transvenous lead based systems in 1990s to subcutaneous ICD systems more recently. As far as transvenous lead based ICD systems are concerned, major advancements have occurred that include decrease in ICD device size and use of biphasic shock waveform. Many software and algorithmic developments have redefined optimization of defibrillation waveform, supraventricular-ventricular tachycardia discriminators, avoidance of unnecessary right ventricular pacing, delivery of anti-tachycardia pacing during charging etc.. However, not all of the technological advances accepted for clinical use have been trouble free. Use of newer ICD lead designs with reduced caliber resulted in unanticipated problems like lead fracture or insulation failure in some of them warranting their recall [1]. Another recent advancement in the lead design is the development of DF-4 technology. The traditional DF-1 lead design has bi/trifurcated lead connectors that integrate in to a single lead body through a yoke. Use of the newer DF-4 ICD lead technology has simplified the implant process to some extent and has certain other advantages.

01 Oct 2013·Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacingQ4 · MEDICINE

First clinical experience with the new four-pole standard connector for high-voltage ICD leads. Early results of a multicenter comparison with conventional implant outcomes

Q4 · MEDICINE

Article

Author: Matteo Santamaria ; Luca Santini ; Domenico Sergi ; Quintino Parisi ; Claudio Tondo ; Lida P. Papavasileiou ; Francesco Romeo ; Luigi Di Biase ; Germana Panattoni ; Massimo Mantica ; Giovanni B. Forleo ; Andrea Natale

PURPOSE:

A new four-pole connector system (DF-4) for transvenous high-voltage implantable cardioverter defibrillators (ICD) is currently available in clinical practice. However, no clinical data demonstrating the safety and effectiveness of this complex electromechanical design is available. This study aims to test the safety and effectiveness of this newly designed system compared to the conventional DF-1 leads.

METHODS:

During a 3-year period, 351 consecutive patients were implanted with DF-4 leads as part of an ICD or ICD-cardiac resynchronization therapy system. Patients were matched for age, sex, and follow-up with 154 patients implanted with a standard DF-1 lead. The primary outcome of the study was defibrillation lead failure, defined as the need for lead removal or capping. Operative, electrical, and safety data were obtained at implant and during postoperative follow-up.

RESULTS:

Implantation success rate in both groups was 100 %. A trend towards shorter procedure time was observed in the DF-4 group but the difference did not reach statistical significance. Handling characteristics of the DF-4 leads were graded better than those of DF-1 models. During a total follow-up of 8,130.5 lead-months, there were nine ICD-lead failures (four system erosion/infections and five electrical lead dysfunctions). The overall incidence of electrical lead failure was 0.64 vs. 0.97 per 100 lead-years, for DF-4 and DF-1 leads, respectively (P = 0.2).

CONCLUSIONS:

This multi-center experience provides strong evidence that the feasibility and safety of this novel technology compare favorably with those of the conventional DF-1 leads.

01 Nov 2009·Journal of ethnopharmacologyQ2 · MEDICINE

Proliferative inhibition of danxiongfang and its active ingredients on rat vascular smooth muscle cell and protective effect on the VSMC damage induced by hydrogen peroxide

Q2 · MEDICINE

Article

Author: Yu Tang ; Yuhang Li ; Xiaorong Li ; Ming Xue ; Li Wu ; Lijuan Wang

AIM OF THE STUDY:

Danxiongfang (DF) is a new Chinese medicine formula used to treat atherosclerosis and vascular restenosis. The active ingredients in DF are danshensu (DSS), tanshinones (cryptotanshinone, CT) and ferulic acid (FA). The aim of present study was to evaluate the inhibitory effects of DF and its active ingredients on cell proliferation and protection against hydrogen peroxide (H(2)O(2))-induced injury in rat vascular smooth muscle cells (VSMC) in vitro.

METHODS:

VSMC proliferation was assayed by cell counting and measurement of cell viability using the 3-(4, 5-dimethylthiazol -2yl)-2, 5-diphenyltetrazolium bromide (MTT) method and protein content was measured by the Bradford method. The nitric oxide (NO) level was detected by an assay kit. The endothelin-1 (ET-1) level was measured by ELISA. The protective effects of DF and its active ingredients on H(2)O(2)-induced cell injury was evaluated in terms of cell viability (MTT assay), superoxide dismutase (SOD) activity and malondialdehyde (MDA) levels. Hydroxyl free radicals generated by the Fenton reaction was detected with the spin-trapping technique on an electron spin resonance spectrometer.

RESULTS:

The results suggest that DSS, CT, FA and DF inhibited VSMC proliferation by increasing the NO level and decreasing the ET-1 content. In rat VSMCs exposed to H(2)O(2), FA, DSS, CT and the six formulations of DF increased cell viability and SOD activity, and reduced the levels of MDA and hydroxyl free radicals. These effects of FA, DSS and CT occurred in a dose-dependent manner. Of the six formulas, DF 4 and DF 5 had the more significant activities. The effects of DF were much greater than those of the individual ingredients, even though the concentrations of these ingredients in the DF formulas were much lower than the doses of the individual ingredients used in each study, indicating markedly synergistic effects of DSS, CT and FA in DF on rat VSMCs.

CONCLUSIONS:

these findings provide a pharmacological foundation for the clinical use of DF in the prevention and treatment of hyperlipidemia and atherosclerosis relevant to endothelial cell proliferation and damage.

100 Deals associated with DF-004

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