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マルチターゲット療法 - 末期肺癌の進行に対して新しい併用療法が有望

Multi-Targeted Therapies - New Wave of Combination Therapies in Late Stage Development for Lung Cancer Offer Promise

発行 GBI Research 商品コード 246723
出版日 ページ情報 英文 55 Pages
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マルチターゲット療法 - 末期肺癌の進行に対して新しい併用療法が有望 Multi-Targeted Therapies - New Wave of Combination Therapies in Late Stage Development for Lung Cancer Offer Promise
出版日: 2012年07月10日 ページ情報: 英文 55 Pages
概要

当レポートは、癌に対する治療薬組み合わせとマルチターゲット療法の発見とその進展について精査しており、癌治療において多数標的に対しいて作用する薬品の特定や設計に用いられる様々な方法や技術を明らかにしています。当レポートはまた、癌治療において多数の標的に対して作用できる併用療法の設計と開発、ならびに併用療法を取り巻く課題や問題点について詳細な分析を行っており、概略下記の構成でお届けいたします。

第1章 目次

第2章 マルチターゲット療法 - 概要

  • イントロダクション
    • 生体ネットワーク
    • 多成分薬品の歴史
    • マルチターゲット療法の種類
    • 多くの小分子薬品は無差別型
    • 標的外効果ならびに薬品リポジショニング
  • 無差別型薬剤と併用療法

第3章 マルチターゲット医薬品の設計

  • リードジェネレーション手法
    • 知識ベース手法
    • スクリーニング
    • フラグメントベース手法
    • In Silico (コンピュータシミュレーション)によるスクリーニング法
    • 結論
    • リードの最適化に関する課題
  • マルチターゲット・プロテインキナーゼ阻害薬
    • 初期のキナーゼ阻害薬
    • 新設計のマルチキナーゼ阻害薬
    • 癌遺伝子依存
    • 抵抗性の克服

第4章 併用療法の設計

  • どの製品同士を結びつけるか
    • 細胞ベースの表現型分析
    • 合成致死性
  • 二つの新薬組み合わせの設計
  • 併用薬の開発と設計の課題
    • 複合毒性
    • 併用して使用する医薬開発に関するFDA勧告
    • 臨床試験設計
    • 医薬の共同開発

第5章 末期癌に対する併用療法のパイプライン分析

  • 組み合わせ薬品数別オンコロジーパイプライン第III相試験
  • 適応症別オンコロジーパイプライン第III相試験
    • 総合
    • 肺癌
    • 乳癌
    • 結腸直腸癌
    • リンパ腫
    • 多発性骨髄腫
    • 卵巣癌
    • 前立腺癌
    • 白血病
    • 頭頸部癌
    • 扁平上皮細胞癌
    • その他の腫瘍適応症

第6章 付録

付表

付図

目次

Summary

GBI Research, the leading business intelligence provider, has released its latest research, "Multi-Targeted Therapies - New Wave of Combination Therapies in Late Stage Development for Lung Cancer Offer Promise", which provides an overview of the discovery and development of therapeutic drug combinations and multi-target drugs for oncology. The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts. The report provides an insight into different methods and techniques used to identify and design drugs that act upon multiple targets in the treatment of cancer. It also focuses on the design and development of combination therapies to address multiple targets in oncology and the challenges surrounding this.

Pipeline analysis of the Phase III oncology pipeline focuses on indications such a lung cancer, breast cancer, colorectal cancer, prostate cancer, ovarian cancer, leukemia, lymphoma, head and neck cancer and multiple myeloma. The most common types of drug combinations used to treat these indications are highlighted and promising molecules in each indication have been identified.

Scope

  • An introduction to network biology and its implications in the design of drugs and cancer therapy.
  • The rationale behind the use of multi-target drugs or combination therapy to address multiple targets in cancer treatments.
  • A comparison of the strengths and weaknesses in the multi-target approach to the use of drug combinations.
  • Methods and techniques for the discovery and design of multi-target drugs.
  • Methods for designing combination therapies for cancer and the challenges involved in the process.
  • Late-stage pipeline analysis of combination therapies in oncology in indications such as lung cancer, breast cancer, colorectal cancer, prostate cancer and ovarian cancer.

Reasons to buy

  • Develop business strategies by understanding the trends shaping and driving research in the field of multi-target therapies.
  • Understand the processes being used to design and develop multi-target drugs and combination therapies and identify some of the challenges involved in this.
  • Identify key molecules in development being used in combination based on indication.
  • Reinforce R&D pipelines by identifying common drug class combinations in the pipeline for different cancer indications.

Executive Summary

Two Stones to Kill One Bird? Combination Therapies Could be the Future of Cancer Treatment.

In the ongoing battle against cancer, the medical community is looking to promising multi-targeted therapies for more effective and enduring treatments, says a new report by pharmaceutical industry observers GBI Research.

According to the report, there is a wave of combination therapies in late stage development that have the potential to revolutionize long-term oncological treatment by addressing the complexities of cancer growth.

In Silico methods (the use of computer simulations) have been instrumental in the generation of biological and chemical data on ligands and targets. These same methods are now being employed to identify and design multi-target compounds, facilitated by the wealth of bioactivity information advanced computer simulations provide.

GBI Research's intelligence shows that lung cancer treatments represent the greatest share of the Phase III combination therapy development pool with 16%. This relatively high percentage is not surprising considering the disease's growing prevalence around the world due to an increase in tobacco consumption in emerging economies such as China. The second and third most populous combination therapies in Phase III were breast cancer and colorectal cancer, with 13.4% and 8.5%, respectively.

There are, however, regulatory problems regarding the co-development of novel drugs. The primary concern is that this process will inevitably provide less information about the safety and effectiveness of these agents than if they were developed and tested individually.

The FDA has drafted guidance and recommendations on how combination therapies should be processed, including a proposal that drugs should only be developed in combination when there is a compelling biological rationale for the use of the combination, or where the drugs cannot be developed individually (if this were lead to drug resistance, for example).

Combinations also need to be shown in preliminary clinical studies to provide greater-than-additive activity or a more durable response compared to using the agents alone.

Multi-Targeted Therapies - New Wave of Combination Therapies in Late Stage Development for Lung Cancer Offer Promise

This report provides an overview of the discovery and development of therapeutic drug combinations and multi-target drugs for oncology.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts.

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Multi-Targeted Therapies - Overview

  • 2.1. Introduction
    • 2.1.1. Biological Networks
    • 2.1.2. History of Multi-component Drugs
    • 2.1.3. Types of Multi-Targeted Therapy
    • 2.1.4. Many Small Molecule Drugs are Promiscuous
    • 2.1.5. Off-target Effects and Drug Repositioning
  • 2.2. Promiscuous Drugs versus Combination Therapies

3. Designing Multi-Target Drugs

  • 3.1. Lead Generation Approaches
    • 3.1.1. Knowledge-based Approaches
    • 3.1.2. Screening
    • 3.1.3. Fragment-based Approach
    • 3.1.4. In Silico Screening Methods
    • 3.1.5. Conclusions
    • 3.1.6. Challenges of Lead Optimization
  • 3.2. Multi-Target Protein Kinase Inhibitors
    • 3.2.1. Early Marketed Kinase Inhibitors
    • 3.2.2. Newer Designed Multi-kinase Inhibitors
    • 3.2.3. Oncogene Addiction
    • 3.2.4. Overcoming Resistance

4. Designing Combination Therapies

  • 4.1. Which Products to Combine?
    • 4.1.1. Cell-based Phenotypic Assays
    • 4.1.2. Synthetic Lethality
  • 4.2. Designing Dual Novel Drug Combinations
  • 4.3. Challenges for Development and Design of Combination Drugs
    • 4.3.1. Combined Toxicity
    • 4.3.2. FDA Guidelines for Development of Drugs for Use in Combination
    • 4.3.3. Clinical Trial Design
    • 4.3.4. Developing Drugs in Collaboration

5. Pipeline Analysis of Late Stage Oncology Combination Therapies

  • 5.1. Phase III Oncology Pipeline by Number of Drugs in Combination
  • 5.2. Phase III Oncology Pipeline by Indication
    • 5.2.1. Overall
    • 5.2.2. Lung Cancer
    • 5.2.3. Breast Cancer
    • 5.2.4. Colorectal Cancer
    • 5.2.5. Lymphoma
    • 5.2.6. Multiple Myeloma
    • 5.2.7. Ovarian Cancer
    • 5.2.8. Prostate Cancer
    • 5.2.9. Leukemia
    • 5.2.10. Head and Neck Cancer
    • 5.2.11. Squamous Cell Carcinoma
    • 5.2.12. Other Oncology Indications

6. Appendix

  • 6.1. Abbreviations
  • 6.2. Sources
  • 6.3. Research Methodology
    • 6.3.1. Secondary Research
    • 6.3.2. Primary Research
    • 6.3.3. Expert Panel Validation
  • 6.4. Contact Us
  • 6.5. Disclaimer

List of Tables

  • Table 1: Clinical Trial Design Considerations for Three Typical Scenarios Combining Drug A and Drug B
  • Table 2: Combination Therapies in Oncology, Phase III Pipeline by Number of Drugs in Combination. 2012
  • Table 3: Combination Therapies in Oncology, Phase III Pipeline by Indication, 2012
  • Table 4: Phase III Pipeline Combinations in Lung Cancer
  • Table 5: Phase III Pipeline Combinations in Breast Cancer
  • Table 6: Phase III Pipeline Combinations in Colorectal Cancer
  • Table 7: Phase III Pipeline Combinations in Lymphoma
  • Table 8: Phase III Pipeline Combinations in Multiple Myeloma
  • Table 9: Phase III Pipeline Combinations in Ovarian Cancer
  • Table 10: Phase III Pipeline Combinations in Prostate Cancer
  • Table 11: Phase III Pipeline Combinations in Leukemia
  • Table 12: Phase III Pipeline Combinations in Head and Neck Cancer
  • Table 13: Phase III Pipeline Combinations in Squamous Cell Carcinoma
  • Table 14: Phase III Pipeline Combinations in Remaining Oncology Indications

List of Figures

  • Figure 1: Three Different Approaches to Multi-Target Therapy
  • Figure 2: Determining if Co-development is an Appropriate Development Option
  • Figure 3: Combination Therapies in Oncology, Phase III Pipeline by Number of Drugs in Combination, 2012
  • Figure 4: Combination Therapies in Oncology, Phase III Pipeline by Indication, 2012
  • Figure 5: Multi-Targeted Therapies, Drug Category and Color Used for Analysis
  • Figure 6: Multi-Targeted Therapies, Phase III Pipeline Combinations in Lung Cancer, 2012
  • Figure 7: Multi-Targeted Therapies, Phase III Pipeline Combinations in Breast Cancer, 2012
  • Figure 8: Multi-Targeted Therapies, Phase III Pipeline Combinations in Colorectal Cancer, 2012
  • Figure 9: Multi-Targeted Therapies, Phase III Pipeline Combinations in Lymphoma, 2012
  • Figure 10: Multi-Targeted Therapies, Phase III Pipeline Combinations in Multiple Myeloma, 2012
  • Figure 11: Multi-Targeted Therapies, Phase III Pipeline Combinations in Ovarian Cancer, 2012
  • Figure 12: Multi-Targeted Therapies, Phase III Pipeline Combinations in Prostate Cancer, 2012
  • Figure 13: Multi-Targeted Therapies, Phase III Pipeline Combinations in Leukemia, 2012
  • Figure 14: Multi-Targeted Therapies, Phase III Pipeline Combinations in Head and Neck Cancer, 2012
  • Figure 15: Multi-Targeted Therapies, Phase III Pipeline Combinations in Squamous Cell Carcinoma, 2012
  • Figure 16: Color Map Showing Phase III Pipeline Combinations in Remaining Oncology Indications, 2012
  • Figure 17 : Color Map Showing Phase III Pipeline Combinations in Remaining Oncology Indications, 2012 (cont)
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