Endpoints-Clinical Trials in Orphan Diseases - Highest Number of Terminated Trials Focused on Mulitiple Myeloma

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Endpoints-Clinical Trials in Orphan Diseases - Highest Number of Terminated Trials Focused on Mulitiple Myeloma

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Endpoints-Clinical Trials in Orphan Diseases - Highest Number of Terminated Trials Focused on Mulitiple Myeloma

Summary

GBI Research, the leading business intelligence provider, has released its latest research report, "Endpoints-Clinical Trials in Orphan Diseases - Highest Number of Terminated Trials Focused on Mulitiple Myeloma" providing an insight into different endpoints that are used in orphan disease clinical trials. The report examines different aspects of clinical trial endpoints in orphan diseases, such as analysis of major marketed orphan drugs with an emphasis on safety and efficacy details, Phase II and Phase III clinical trial analyses for both completed and ongoing clinical trials, most promising orphan drugs with more emphasis on safety, efficacy and clinical trial details, and terminated trial analysis. The company profiling highlights the orphan drugs of different companies.

These rare diseases have a low rate of prevalence in the existing population and a physician rarely gets to see patients with these conditions. Most of the orphan diseases are often genetic and hence they persist throughout a person's life. It is estimated that 80% of orphan diseases have genetic origins. The remaining diseases occur due to allergies, degenerative and proliferative causes and as a result of infection. The symptoms for these diseases are not immediate and it appear later for most of the conditions. The definition of orphan diseases varies with geography and is primarily dependent upon the prevalence of a disease.

This report "Endpoints- Clinical Trials in Orphan Diseases" highlights the seven major orphan diseases: Huntington's disease, acute myeloid leukemia, amyotrophic lateral sclerosis, Hodgkin's lymphoma, multiple myeloma, ovarian cancer and pancreatic cancer.

The term endpoint refers to an outcome or measure of a clinical trial. Endpoints can include all kinds of aspects, those related to the effectiveness of treatment and others. However, endpoint selection must take into account the need to obtain the most information of therapeutic interest with the least risk and discomfort for the individual. Also, the endpoints must be in line with the objective of the study and represent the most effective way of assessing a pharmacological response.

Scope

- Data and analysis on the marketed products and analysis of their efficacy and safety details

- Analysis of the seven major orphan diseases which are Huntington's disease, acute myeloid leukemia, amyotrophic lateral sclerosis, Hodgkin's lymphoma, multiple myeloma, ovarian cancer and pancreatic cancer.

- Analysis of the Phase III and Phase II clinical trials in terms of percentage of cases. An analysis of terminated trials is also included in this chapter. Only industry-sponsored studies are included in the report.

- Analysis on most promising molecules of the seven major orphan diseases with emphasis on their efficacy and safety details.

- Company Profiling details the companies with a strong market presence.

Reasons to buy

- Understand the trends in clinical trial endpoints used for orphan diseases

- Build effective strategies to launch pipeline products by identifying potential geographies

- Exploit in-licensing and out-licensing opportunities by identifying products that might probably fill their portfolio gaps

- Align your product portfolio to the markets with high growth potential

- Develop market-entry and market expansion strategies by identifying the leading therapeutic segments and geographic markets poised for strong growth

- Reinforce R&D pipelines by identifying new target mechanisms which can produce first-in-class molecules with improved efficiency and safety profiles

- Develop key strategic initiatives by understanding the key focus areas of leading companies

List of Tables

1.1 List of Tables

Table 1: Huntington's disease, Global, Primary and Secondary Endpoints of Phase III Molecules , 2010 13

Table 2: Huntington's disease, Global, Primary and Secondary Endpoints of Phase II Molecules , 2010 16

Table 3: Acute Myelocytic Leukemia, Global, Primary and Secondary Endpoints of Phase III Molecules , 2010 21

Table 4: Acute Myelocytic Leukemia, Global, Primary and Secondary Endpoints of Phase II Molecules , 2010 25

Table 5: Acute Myelocytic Leukemia, Global, Discontinued Drugs' Primary and Secondary Endpoints, 2010 31

Table 6: Amyotrophic Lateral Sclerosis, Global, Primary and Secondary Endpoints of Phase II Molecules , 2010 36

Table 7: Amyotrophic Lateral Sclerosis, Global, Discontinued Drugs' Primary and Secondary Endpoints, 2010 38

Table 8: Hodgkin's lymphoma, Global, Primary and Secondary Endpoints of Phase III Molecules , 2010 40

Table 9: Hodgkin's lymphoma, Global, Primary and Secondary Endpoints of Phase II Molecules , 2010 44

Table 10: Hodgkin's Lymphoma, Global, Discontinued Drugs' Primary and Secondary Endpoints, 2010 47

Table 11: Multiple Myeloma, Global, Primary and Secondary Endpoints of Phase III Molecules , 2010 52

Table 12: Multiple Myeloma, Global, Primary and Secondary Endpoints of Phase II Molecules , 2010 59

Table 13: Multiple Myeloma, Global, Discontinued Drugs' Primary and Secondary Endpoints, 2010 66

Table 14: Ovarian Cancer, Global, Approved Products, 1990-2010 69

Table 15: Ovarian Cancer, Global, Marketed Drugs Efficacy, 2010 69

Table 16: Ovarian Cancer, Global, Gemzar - Adverse Reactions, 2010 71

Table 17: Ovarian Cancer, Global, Hycamtin - Adverse Reactions, 2010 72

Table 18: Ovarian Cancer, Global, Major Marketed Product Comparison in Market, 2010 73

Table 19: Ovarian Cancer, Global, Primary and Secondary Endpoints of Phase III Molecules , 2010 75

Table 20: Ovarian Cancer, Global, Primary and Secondary Endpoints of Phase II Molecules, 2010 79

Table 21: Ovarian Cancer, Global, Discontinued Drugs' Primary and Secondary Endpoints, 2010 87

Table 22: Pancreatic Cancer, Global, Gemcitabine Based Combinations, 2010 89

Table 23: Pancreatic Cancer, Global, Efficacy Results for Tarceva and Gemcitabine Versus Placebo, 2010 91

Table 24: Pancreatic Cancer, Global, Major Marketed Products , 2010 91

Table 25: Pancreatic Cancer, Global, Primary and Secondary Endpoints of Phase III Molecules , 2010 92

Table 26: Pancreatic Cancer, Global, Primary and Secondary Endpoints of Phase II Molecules, 2010 97

Table 27: Pancreatic Cancer, Global, Discontinued Drugs' Primary and Secondary Endpoints, 2010 102

Table 28: Novartis AG, Global, Endpoints of Major Orphan Disease Pipeline Molecules, 2010 103

Table 29: Johnson & Johnson, Global, Endpoints of Major Orphan Disease Pipeline Molecules, 2010 105

Table 30: Sanofi, Global, Endpoints of Major Orphan Disease Pipeline Molecules, 2010 108

Table 31: Amgen, Global, Endpoints of Major Orphan Disease Pipeline Molecules, 2010 110

Table 32: Celgene Corporation, Global, Endpoints of Major Orphan Disease Pipeline Molecules, 2010 112

List of Figures

1.2 List of Figures

Figure 1: Huntington's disease, Global, Clinical Pipeline Phase III by Primary Endpoints, 2010 14

Figure 2: Huntington's disease, Global, Clinical Pipeline Phase III by Secondary Endpoints, 2010 15

Figure 3: Huntington's disease, Global, Clinical Pipeline Phase II by Secondary Endpoints, 2010 17

Figure 4: Acute Myelocytic Leukemia, Global, Clinical Pipeline Phase III by Primary Endpoints, 2010 22

Figure 5: Acute Myelocytic Leukemia, Global, Clinical Pipeline Phase III by Secondary Endpoints, 2010 23

Figure 6: Acute Myelocytic Leukemia, Global, Clinical Pipeline Phase II by Primary Endpoints, 2010 29

Figure 7: Acute Myelocytic Leukemia, Global, Clinical Pipeline Phase II by Secondary Endpoints, 2010 30

Figure 8: Amyotrophic Lateral Sclerosis, Global, Clinical Pipeline Phase III by Primary Endpoints, 2010 34

Figure 9: Amyotrophic Lateral Sclerosis, Global, Clinical Pipeline Phase III by Secondary Endpoints, 2010 35

Figure 10: Amyotrophic Lateral Sclerosis, Global, Clinical Pipeline Phase II by Primary Endpoints, 2010 37

Figure 11: Amyotrophic Lateral Sclerosis, Global, Clinical Pipeline Phase II by Secondary Endpoints, 2010 38

Figure 12: Hodgkin's lymphoma, Global, Clinical Pipeline Phase III by Primary Endpoints, 2010 41

Figure 13: Hodgkin's lymphoma, Global, Clinical Pipeline Phase III by Secondary Endpoints, 2010 42

Figure 14: Hodgkin's lymphoma, Global, Clinical Pipeline Phase II by Primary Endpoints, 2010 45

Figure 15: Hodgkin's Lymphoma, Global, Clinical Pipeline Phase II by Secondary Endpoints, 2010 46

Figure 16: Multiple Myeloma, Global, Clinical Pipeline Phase III by Primary Endpoints, 2010 56

Figure 17: Multiple Myeloma, Global, Clinical Pipeline Phase III by Secondary Endpoints, 2010 57

Figure 18: Multiple Myeloma, Global, Clinical Pipeline Phase II by Primary Endpoints, 2010 64

Figure 19: Multiple Myeloma, Global, Clinical Pipeline Phase II by Secondary Endpoints, 2010 65

Figure 20: Ovarian Cancer, Global, Clinical Pipeline Phase III by Primary Endpoints, 2010 77

Figure 21: Ovarian Cancer, Global, Clinical Pipeline Phase III by Primary Endpoints, 2010 77

Figure 22: Ovarian Cancer, Global, Clinical Pipeline Phase II by Primary Endpoints, 2010 85

Figure 23: Ovarian Cancer, Global, Clinical Pipeline Phase II by Secondary Endpoints, 2010 86

Figure 24: Pancreatic Cancer, Global, Clinical Pipeline Phase III by Primary Endpoints, 2010 94

Figure 25: Pancreatic Cancer, Global, Clinical Pipeline Phase III by Secondary Endpoints, 2010 95

Figure 26: Pancreatic Cancer, Global, Clinical Pipeline Phase II by Primary Endpoints, 2010 100

Figure 27: Pancreatic Cancer, Global, Clinical Pipeline Phase II by Secondary Endpoints, 2010 101

Companies Mentioned

Novartis

Johnson & Johnson

Sanofi

Amgen

Celgene Corporation

To order this report:

Pathology Industry: Endpoints-Clinical Trials in Orphan Diseases - Highest Number of Terminated Trials Focused on Mulitiple Myeloma

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