New Report Examines Emerging Therapeutic, Diagnosticand Market Opportunities in the Area of...

DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c55101) has announced the addition of "Cancer Stem Cells: Emerging Therapeutic, Diagnostic and Market Opportunities" to their offering.

Overview: Tumours and haematological cancers contain small populations

of cells that are believed to play a critical role in the progression of the disease. These cells, named Cancer Stem Cells (CSCs), have been found in leukaemia, myeloma, breast, prostate, pancreas, colon, brain and lung cancers. It is thought that CSCs are critically involved in the development and metastatic spread of cancer. CSCs have also demonstrated resistance to a number of conventional therapies and it is thought that that this explains why it is difficult to completely eradicate the disease and why recurrence is an ever-present threat. If these findings are now confirmed in the clinic, the selective targeting of CSCs will offer a new paradigm in both cancer therapeutics and diagnostics. Currently there are more than 30 CSC R&D programmes in progress, around 50% of which are at Phase I or beyond. Patient data from the first clinical trials of drugs believed to target CSCs, are now being reported. Most CSC R&D programmes are being taken forward by SME's and > 90% of the 70 patents in this area (which more than doubled in 2007) have been filed by Universities. Substantial opportunity for collaboration is this field has recently lead to agreements between SMEs and major pharmaceutical companies. This includes a recent announcement of a collaboration between GSK and Oncomed Pharmaceuticals, Inc.

Drug Discovery and Pipeline: More than ten different strategies are being actively researched to enable the selective therapeutic targeting of CSCs, which are described in this report. In December 2007, clinical data were reported on GSK's Tykerb (which is already approved in the US for breast cancer), that targets the CD44+/CD24+ population of breast cancer cells i.e. breast CSCs. ChemGenix has also recently published clinical data from a Phase II/III CML clinical trial of omacetaxine mepesuccinate, which is believed to target CSCs. Stemline Therapeutics have reported that their investigational CSC-targeting molecule SL-401, has demonstrated single agent anti-tumour activity in acute myeloid leukaemia in a multi-centre Phase I/II dose escalation study. Currently around 30 companies or commercially based research organisations are progressing R&D activities in the CSC field, 65% of which are SME's. This report identifies five "Top-25" pharmaceutical companies that are progressing developments relating to CSCs. Of the current 30 R&D programmes, around 50% are at Phase I or beyond. The availability of isolated CSCs to drug discovery companies offers opportunities to identify new druggable targets and to re-examine existing drug libraries that have not been screened against this unique subset of cells, or xenograft models developed from them.

Cancer Diagnostics: CSCs are believed to be causally linked to the development and metastatic spread of cancer. If this is confirmed in man, this will likely place CSCs at the heart of cancer diagnostics. Researchers have identified a number of surface proteins such as CD44, CD133 and many others, which may have important application as biomarkers and diagnostics. Some of these surface proteins are found on a number of different CSCs, whereas others appear to be unique to certain CSCs. A number of intracellular markers found in CSCs, may also have diagnostic utility. These developments are described in this report. CD133 mRNA levels in peripheral blood, measured using RT-PCR, have been found to predict colon cancer recurrence. There is a need for new methodologies that isolate and characterise circulating tumour cells (CTCs) in the blood, that can be applied to CSCs. CTC technologies using the EpCam marker to isolate these cells are able to predict colon cancer recurrence. The adaption of these techniques based on specific CSC phenotypes may provide sensitive new methods for identifying CSCs in the body. Innovation in advanced microfluidic, chip-based and genetic/phenotypic screening technologies are anticipated in the future. OncoMed Pharmaceuticals have announced the discovery of a gene expression profile of CSCs (breast and other cancers), that correlate with clinical outcome.

This Report: This report gives a comprehensive up-to-date review of global R&D on CSCs and strategies to target them. This includes around 30 companies or commercially based research organisations (including 20 SMEs and five major pharmaceutical companies) that are progressing drug discovery activities, including drug pipeline (pre-clinical to Phase III), discovery strategy, candidate molecules, drug targets, current clinical trials and related areas. Also covered are current developments on the detection of CSCs and new diagnostic approaches. Commercial opportunities in drug discovery and diagnostics relating to CSCs are also presented. More than 50 academic research teams from 13 different countries are reviewed, together with leading discoveries in this field. Current patents referring to CSCs (70+ by Dec 2007) are also presented.

Executive Summary 6
Chapter 1 Cancer Stem Cells 13
1.1 Introduction 15
1.2 What are CSCs? 17
1.3 Different Cancers 17
1.4 Markets 19
1.5 Unmet Need 19
1.6 Research and Development 21
Chapter 2 Research and Development 24
2.1 Background 26
2.2 Research 28
2.3 Drug Development 29
Chapter 3 Drug Discovery 30
Summary 31
3.1 Thinking Differently 32
3.2 Resistance to Therapy 33
3.3 The Stem Cell Niche 35
3.4 Metabotropic Receptors 35
3.5 Telomerase 36
3.6 Notch 36
3.7 Hedgehog and Wnt 37
3.8 Bmi-1s 39
3.9 CSC-Targeting Viruses 39
3.10 Metastasis 40
3.11 MicroRNAs 40
3.12 CSC Markers 41
3.13 Drug Pipeline 46
Chapter 4 Diagnostics 61
Summary 63
4.1 Background 64
4.2 CSC Markers 64
4.3 Circulating Tumour Cells 67
4.4 The Invasiveness Gene Signature 68
4.5 Microarrays 68
4.6 Hedgehog Activity 69
4.7 Sox 2 70
4.8 Other 71
Chapter 5 Emerging Markets and Opportunities 73
Summary 74
5.1 Drug Discovery 75
5.2 Diagnostics 79
5.3 Markets 80
Chapter 6 Patents 82
Summary 83
6.1 Patents 84
Chapter 7 Conclusions 94
71. Overview 95
7.2 Drug Discovery and Pipeline 96
7.3 Diagnostics 101
Appendix 1 102-108
List of Figures
Figure 2.1 Journal publications relating to Cancer Stem Cells,
 2000-2006
Figure 2.2 Patents relating to Cancer Stem Cells, 1999-2006
Figure 2.3 Global academic research groups working on Cancer Stem
 Cells
Figure 4.1 Diagnostic strategies for the targeting of Cancer Stem
 Cells
Figure 5.1 Opportunities in the therapeutic targeting of Cancer Stem
 Cells
Figure 5.2 Opportunities relating to Cancer Stem Cell models
Figure 5.9 Sales (2004) and projected growth of targeted cancer
 therapies
Figure 6.1 Patents relating to Cancer Stem Cells, 1999-2007, by year
 (Source: Delphion)
Figure 7.1 Development pipeline of candidate molecules that target
 CSCs
Figure 7.2 Potential strategies for the therapeutic targeting of
 Cancer Stem Cells
Figure 7.3 Challenges in the therapeutic targeting of Cancer Stem
 Cells
List of Tables
Table 2.1 Overview of the global CSC-targeting drug development
 pipeline
Table 3.1 Table 3.1 (a-e) CSC markers and potential drug targets
 currently in research and development ++ = candidate in the drug
 development pipeline
Table 3.2 Development pipeline of CSC-targeting candidate drug
 molecules
Table 4.1 (a-b) CSC Markers
Appendices
Appendix 1 (a-g) Summary of 56 research groups working on or in areas
 relating to cancer stem cells, by organisation, researcher, summary,
 cancer type and country

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