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排名前五的药物类型	数量

抗毒素	1

排名前五的靶点	数量

地高辛	1

关联

1

项与 Protherics, Inc. 相关的药物

Anti-digoxin polyclonal antibody

地高辛特异抗体Fab片段

靶点

地高辛

作用机制

地高辛抑制剂 [+1]

在研机构

BTG International, Inc. [+2]

原研机构

BTG International Ltd.

在研适应症

中毒 [+2]

非在研适应症

先兆子痫

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2001-08-31

100 项与 Protherics, Inc. 相关的临床结果

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0 项与 Protherics, Inc. 相关的专利（医药）

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3

项与 Protherics, Inc. 相关的文献（医药）

2006-01-01·Clinical Toxicology3区 · 医学

A Preliminary Study of Tricyclic Antidepressant (TCA) Ovine FAB for TCA Toxicity

3区 · 医学

Article

作者: Keith K. Burkhart ; J. Ward Donovan ; Suzanne B. Ward ; Richard C. Dart ; Gerald F. O'Malley ; Gregory Bogdan ; Kennon Heard

BACKGROUNDAnimal studies suggest that tricyclic antidepressant antibody fragments (TCA Fab) may be a useful therapy for tricyclic antidepressant poisoning. The objective of this study is to determine if TCA Fab increases total serum TCA levels without raising free serum TCA levels in human overdose patients, indicating that TCA Fab effectively binds TCA.METHODSThis was a prospective, dose escalation study of patients with mild to moderate TCA poisoning. Patients were treated with an escalating intravenous infusion totaling 7 or 14 gm of TCA Fab. The outcomes of interest were serum TCA levels (total and free), worsening of TCA toxicity, and adverse effects.RESULTSSeven patients were treated with Fab. Infusion of TCA Fab was associated with a dramatic increase in total serum TCA levels, while free TCA levels fell in both dosing groups. There were no significant changes in QRS duration, heart rate or mean arterial pressure associated with the Fab Infusion. Worsening of TCA toxicity did not occur despite marked elevation of total serum TCA concentrations. The two patients with the greatest prolongation of QRS showed a prompt shortening in their QRS duration temporally associated with the Fab infusion. Mild wheezing was observed in one asthmatic patient.CONCLUSIONS1) TCA Fab raises total serum TCA levels while lowering free levels in TCA poisoned patients; 2) no toxic effects were associated with the increase in TCA levels and no severe adverse effects were observed during the hospital course following Fab infusion.

2005-11-16·Blood

A Phase I Open-Label Trial To Determine the Pharmacokinetics of Glucarpidase in Subjects with Normal and Impaired Renal Function.

作者: Balan, Guhan ; Phillips, Marc A. ; Auton, Tim R. ; Smith, William B. ; Ward, Suzanne B.

AbstractMethotrexate (MTX) is used in high doses in the treatment of cancers such as NHLs, leukemias and osteosarcoma. In some patients it produces renal damage which delays its elimination from the body. Prolonged exposure to high concentrations of MTX results in serious toxic effects. Glucarpidase (Voraxaze™, formerly carboxypeptidase G2) contains a recombinant enzyme which rapidly and predictably breaks down MTX in the blood within 15 minutes of administration. Multiple studies to date have evaluated glucarpidase as an intervention for patients at risk or experiencing toxicities related to MTX overexposure. Continuing studies seek to evaluate the use of glucarpidase in a planned way to circumvent toxicity and prevent prolonged hospitalization. The current study examined the pharmacokinetics of glucarpidase in subjects who had both normal and severely impaired renal function, similar to that of the intended patient population.Methods: Twelve male and female subjects participated in this study; 8 with normal renal function (calculated creatinine clearance >80 mL/min) and 4 with severely impaired renal function (calculated creatinine clearance <30 mL/min). Each subject received a single intravenous dose of glucarpidase 50 units/kg (equivalent to 114.5 μg/kg), infused over 5 min. Serum glucarpidase profiles were evaluated for all subjects using 7 mL blood samples collected at the following time points: pre-dose (prior to start of glucarpidase IV dose), end of 5-minute infusion, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 48, 72, and 96 hours following the start of the infusion. The study protocol was approved by the Crescent City Institutional Review Board IRB (New Orleans, LA) and all subjects gave their written informed consent prior to inclusion in the study.Results: The mean (SD) Cmax for glucarpidase in renally impaired subjects was 2.9 μg/mL (0.83), the mean half-life was 10.0 (2.1) h and mean AUC0-∞ was 24.5(9.4) μg.h/mL. Similar values were found in subjects with normal renal function (mean Cmax 3.1 μg/mL, mean t1/2 9.0 h and mean AUC0-∞ 23.4 μg.h/mL). No adverse events were recorded in the study.Conclusions: The results indicated little effect of renal impairment on the serum pharmacokinetics of glucarpidase. Evaluations of adverse events, clinical laboratory assessments, vital signs, ECGs, and physical examinations indicated that a single 50 unit/kg dose of glucarpidase was safe and well-tolerated when administered to subjects with normal renal function and subjects with severe renal impairment. PK parameters found in this study may be relevant to cancer patients treated with 50 units/kg glucarpidase, including those with MTX-induced renal toxicity.

2000-10-01·Therapeutic Drug Monitoring3区 · 医学

Comparison of the Pharmacokinetics and In Vivo Bioaffinity of DigiTAb Versus Digibind

3区 · 医学

Article

作者: Ujhelyi, Michael R. ; Ward, Suzanne B. ; Sjostrom, Lena

The in vivo digoxin binding affinity and normal pharmacokinetic values of digoxin-immune Fab are unknown. Healthy subjects (n = 16) were randomized to one of the two digoxin-immune Fab products, DigiTAb or Digibind, to compare the in vivo digoxin binding affinity and pharmacokinetic disposition. Each subject received 1 mg of intravenous digoxin infused during 5 minutes followed 2 hours later by 76 mg of either DigiTAb or Digibind. Both Fab products reduced free digoxin serum concentrations to below assay detection with equal ability. Consequently, total digoxin serum concentrations increased approximately 10-fold. Peak total digoxin serum concentrations post-Fab dosing were similar to the pre-Fab peak digoxin concentration for both Fab products (45 +/- 14 and 44 +/- 11 for DigiTAb, pre and post, respectively) 50 +/- 17 and 41 +/- 9 for Digibind, pre and post, respectively) indicating in vivo equimolar binding affinity. While bioaffinity for digoxin was equal between groups, total digoxin area under the curve (AUC) and digoxin-immune Fab AUC were lower in the DigiTAb group compared with the Digibind group. Hence, systemic total digoxin and Fab clearance were greater in the DigiTAb-treated group. In conclusion, equimolar doses of both DigiTAb and Digibind completely bind digoxin in vivo. The ability of digoxinimmune Fab to bind to digoxin is not affected by the systemic disposition of the Fab product.

100 项与 Protherics, Inc. 相关的药物交易

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100 项与 Protherics, Inc. 相关的转化医学

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