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Compositions and methods for treating heart failure

a technology of compositions and methods, applied in the field of neuregulin protein, can solve the problems of increased cost and invasiveness of heart transplantation, increased mortality of ace inhibitors, and increased limitations of other options for preventing or treating heart failur

Inactive Publication Date: 2014-12-11
ZENSUN (SHANGHAI) SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent text describes the use of neuregulin to treat heart failure. The invention is based on the discovery that evaluating heart function or measuring certain biomarkers can help identify heart failure patients who will benefit from neuregulin treatment. The pharmaceutical composition can be administered for an introduction regimen of at least 3, 5, 7, or 10 days, followed by a maintenance regimen of at least 3, 6, or 12 months. The treatment can significantly reduce mortality rate, rehospitalization, and improve biomarkers levels indicating the improvement of heart failure. The technical effect of the invention is to provide an effective treatment for chronic heart failure patients.

Problems solved by technology

While the percent reduction in mortality has been significant, the actual reduction in mortality with ACE inhibitors has averaged only 3%-4%, and there are several potential side effects.
Additional limitations are associated with other options for preventing or treating heart failure.
For example, heart transplantation is clearly more expensive and invasive than drug treatment, and it is further limited by the availability of donor hearts.
Uses of mechanical devices, such as biventricular pacemakers, are similarly invasive and expensive.
Targeted disruption of the NRG-1β or ErbB2 or ErbB4 led to embryonic lethality due to cardiac development defects.

Method used

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  • Compositions and methods for treating heart failure

Examples

Experimental program
Comparison scheme
Effect test

example 1

The effect of Neucardin™ Administration by Different Routes on the Survival Rate of Rats with CHF

[0050]Introduction:

[0051]In this study, we used a coronary artery ligation (CAL) induced CHF model to investigate whether administration of Neucardin™ by IV drip using a micro-injection pump or by subcutaneous (SC) bolus had any effects on survival rate and cardiac hemodynamics, 120 days after the initiation of administration of Neucardin™ 4 weeks after CAL. Echocardiography and cardiac remodeling were also used to determine cardiac function and recovery from CAL.

[0052]2. Methods:

[0053]2.1. Test animals:

[0054]Strain, Origin: Wistar rats, Shanghai SLAC Laboratory Animal CO. LTD; Weight, 200±10 g, male;

[0055]2.2 Test article:

[0056]2.2.1 Neucardin™

[0057]Identification: Recombinant human neuregulin-1 for injection (rhNRG-1, Neucardin™)

[0058]Lot Number: 200607009

[0059]Manufacturer: Zensun (Shanghai) Sci & Tech Co., Ltd

[0060]Dose form: Lyophilized powder

[0061]Appearance: White or off-white cak...

example 2

A Randomized, Double-Blinded, Multi-Center, Placebo Controlled Study to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin 1 in Patients with Chronic Heart Failure Based on Standard Treatment

[0094]To evaluate the efficacy of recombinant human neuregulin-1 for injection on chronic heart failure, a phase II, double-blinded, multi-center, placebo controlled, standard treatment based study was carried out in multiple clinical centers in China. A total of 195 patients with NYHA Class II or III stable chronic heart failure were enrolled and randomized into three groups: placebo, or 0.6 μg / kg and 1.2 μg / kg of rhNRG-1. There were no significant variations in demographics or background therapies among groups. According to the schedule, patients were administered the drug for 10 consecutive days in the hospital first, after finishing the day 11 follow up, they were discharged from the hospital. Another two on site follow up were at day 30 and day 90. A telephone interview was co...

example 3

A Randomized, Double-Blinded, Multi-Center, Placebo Controlled Survival Study of Recombinant Human Neuregulin 1 in Patients with Chronic Heart Failure Based on Standard Treatment

[0109]To evaluate the efficacy of recombinant human neuregulin-1 for injection on chronic heart failure, a phase II, double-blinded, multi-center, placebo controlled, standard treatment based study was carried out in multiple clinical centers in China. A total of 351 patients with NYHA Class III or IV stable chronic heart failure were enrolled and randomized into placebo group or rhNRG-1 group (0.6 μg / kg). There were no significant variations in demographics or background therapies among groups. According to the schedule, patients were administered with the drug for 10 consecutive days in the hospital, after finishing the day 11 follow up, they were discharged from the hospital, and were administered with the drug once weekly from the 3rd week till the 25th week as out-patient. Blood samples of each patient ...

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Abstract

The present invention provides methods for treating chronic heart failure patients using the medication comprising neuregulin. The methods comprise first performing a companion diagnostic test of each patient before treatment; and then providing a suitable treatment to the patient according to the results of the companion diagnostic test. When the result of the test is within a favorite treatment zone, the patient is suitable for heart failure treatment by administering an effective amount of neuregulin.

Description

1. FIELD OF THE INVENTION[0001]The present invention relates to the use of neuregulin protein for the preparation of medication for preventing, treating or delaying heart failure in humans and methods for preventing, treating or delaying heart failure in humans using said medication. Particularly, the present invention provides methods for preventing, treating or delaying heart failure using the medication comprising a neuregulin protein in specific populations of chronic heart failure patients.[0002]2. BACKGROUND OF THE INVENTION[0003]Heart failure affects approximately five million Americans, and more than 550,000 new patients are diagnosed with the condition each year. Current drug therapy for heart failure is primarily directed to angiotensin-converting enzyme (ACE) inhibitors, which are vasodilators that cause blood vessels to expand, lowering blood pressure and reducing the heart's workload. While the percent reduction in mortality has been significant, the actual reduction in...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/18G01N33/68
CPCA61K38/1883G01N2800/52G01N33/6893A61K38/18C07K14/4756A61K36/804A61K45/06A61K9/0019G01N2800/325A61P29/00A61P31/12A61P39/02A61P9/04A61P9/10A61K2121/00G01N33/74G01N2333/58
Inventor ZHOU, MINGDONG
Owner ZENSUN (SHANGHAI) SCI & TECH CO LTD
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