Table of Contents

0.Executive Summary

1.Technologies for suppressing gene function

Introduction

DNA transcription

RNA

Non-coding RNA

RNA research and potential applications

Role of RNA in regulation of the dihydrofolate reductase gene

Gene regulation

Post-transcriptional regulation of gene expression

Alternative RNA splicing

Technologies for gene suppression

Antisense oligonucleotides

Transcription factor decoys

Aptamers

Ribozymes

Aptazymes

RNA aptamers vs allosteric ribozymes

RNA Lasso

Peptide nucleic acid

PNA-DNA chimeras

Locked nucleic acid

Gene silencing

Post-transcriptional gene silencing

TargeTron technology for gene knockout

Definitions and terminology of RNAi

RNAi mechanisms

Non-promoter-associated small RNAs

Piwi-interacting RNAs in germ cell development

Relation of RNAi to junk DNA

RNA editing and RNAi

Historical landmarks in the development of RNAi

2.RNAi Technologies

Introduction

Comparison of antisense and RNAi

Advantages of antisense over siRNAs

Advantages of siRNAs over antisense

RNA aptamers vs siRNA

RNA Lassos versus siRNA

Concluding remarks on antisense vs RNAi

ssRNAi

Antisense vs DNP-ssRNA and DNP-siRNA

LNA and RNAi

LNA for gene suppression

Comparison of LNA and RNAi

Use of siLNA to improve siRNA

RNAi versus small molecules

RNAi in vivo

Cre-regulated RNAi in vivo

RNAi kits

ShortCut™ RNAi Kit

HiScribe™ RNAi Transcription Kit

pSUPER RNAi system

Si2 Silencing Duplex

Techniques for measuring RNAi-induced gene silencing

Application of PCR in RNAi

Real-time quantitative PCR

Assessment of the silencing effect of siRNA by RT-PCR

Fluorescence resonance energy transfer probe for RNA interactions

Bioinformatics tools for design of siRNAs

Random siRNA design

Rational siRNA design

The concept of pooling siRNAs

Criteria for rational siRNA design

BLOCK-iT RNAi Designer

QIAGEN's 2-for-Silencing siRNA Duplexes

Designing vector-based siRNA

iRNAChek for designing siRNA

TROD: T7 RNAi Oligo Designer

siDirect: siRNA design software

Prediction of efficacy of siRNAs

Algorithms for prediction of siRNA efficacy

siRNA databases

Production of siRNAs

Chemical synthesis of short oligonucleotides

In vitro transcription

Generation of siRNAs in vivo

UsiRNAs

siRNA:DNA hybrid molecules

Chemical modifications of siRNAs

Sugar modifications of siRNA

Phosphate linkage modifications of siRNA

Modifications to the siRNA overhangs

Modifications to the duplex architecture

Applications of chemical modification of siRNAs

Synthetic RNAs vs siRNAs

Specificity of siRNAs

Asymmetric interfering RNA

Genome-wide data sets for the production of esiRNAs

ddRNAi for inducing RNAi

ddRNAi technology

Advantages of ddRNAi over siRNA

Short hairpin RNAs

siRNA versus shRNA

Circular interfering RNA

Expressed interfering RNA

RNA-induced transcriptional silencing complex

Inhibition of gene expression by antigene RNA

RNAi vs mRNA modulation by small molecular weight compounds

3.MicroRNA

Introduction

miRNA and RISC

Role of the microprocessor complex in miRNA

miRNAs compared to siRNAs

miRNA and stem cells

Influence of miRNA on stem cell formation and maintenance

Role of miRNAs in gene regulation during stem cell differentiation

miRNA databases

Sanger miRBase miRNA sequence database

Mapping miRNA genes

A database of ultraconserved sequences and miRNA function

A database for miRNA deregulation in human disease

An database of miRNA-target interactions

Role of miRNA in gene regulation

Control of gene expression by miRNA

miRNA-mediated translational repression involving Piwi

Transcriptional regulators of ESCs control of miRNA gene expression

Mechanism of miRNAs-induced silencing of gene expression

miRNA diagnostics

Biochemical approach to identification of miRNA

Computational approaches for the identification of miRNAs

LNA probes for exploring miRNA

Microarrays for analysis of miRNA gene expression

Microarrays vs quantitative PCR for measuring miRNAs

miRNAs as biomarkers of hepatotoxicity

Modification of in situ hybridization for detection of miRNAs

Nuclease Protection Assay to measure miRNA expression

Real-time PCR for expression profiling of miRNAs

Targeting of miRNAs with antisense oligonucleotides

Silencing miRNAs by antagomirs

New tools for miRNA silencing

miRNA-regulated lentiviral vectors

miRNAs as drug targets

miRNAs as targets for antisense drugs

Challenges facing use of miRNAs as drug targets

Target specificity of miRNAs

Prediction of miRNA targets

Role of miRNA in human health and disease

Role of miRNAs in regulation of hematopoiesis

Role of miRNA depletion in tissue regeneration

Role of miRNA in regulation of aging

Role of miRNA in inflammation

Role of miRNAs in regulation of immune system

Role of miRNA in the cardiovascular system

Role of miRNAs in development of the cardiovascular system

Role of miRNAs in angiogenesis

Role of miRNAs in cardiac hypertrophy and failure

Role of miRNAs in conduction and rhythm disorders of the heart

miRNA-based approach for reduction of hypercholesterolemia

miRNA-based approach for restenosis following angioplasty

miRNAs as therapeutic targets for cardiovascular diseases

Concluding remarks and future prospects of miRNA in the cardiovascular system

Role of miRNAs in the nervous system

miRNAs and addiction

miRNAs in neurodegenerative disorders

miRNAs as biomarkers of Alzheimer’s disease

miRNA malfunction in spinal motor neuron disease

miRNAs and retinal neurodegenerative disorders

miRNA and schizophrenia

Role of miRNA in viral infections

Role of miRNA in HSV-1 latency

miRNA and autoimmune disorders

miRNA in systemic lupus erythematosus

miRNA and skin disorders

Role of miRNA in inflammatory skin disorders

Role of miRNAs in cancer

miRNAs linked to the initiation and progression of cancer

Oncomirs

Linking miRNA sequences to cancer using RNA samples

Role of miRNAs in viral oncogenesis

miRNA genes in cancer

miRNAs, embryonic stem cells and cancer

miRNAs and cancer metastases

Role of miRNAs in cancer diagnosis

Cancer miRNA signature

miRNA biomarkers in cancer

Diagnostic value of miRNA in cancer

Prognostic value of miRNA in cancer

miRNAs as basis of cancer therapeutics

Antisense oligonucleotides targeted to miRNA

Delivery of miRNA mimetics in Cancer

Role of miRNAs in adoptive immunotherapy of cancer

Restoration of tumor suppressor miRNA may inhibit cancer

Role of miRNAs in various cancers

miRNA and brain cancer

miRNA and breast cancer

miRNA and colorectal cancer

miRNA and hematological malignancies

miRNA and hepatocellular carcinoma

miRNA and lung cancer

miRNA and nasopharyngeal carcinoma

miRNA and ovarian cancer

miRNA and pancreatic cancer

miRNA and prostatic cancer

miRNA and thyroid cancer

Future prospects of miRNA

Companies involved in miRNA

4.Methods of delivery in RNAi

Introduction

Methods of delivery of oligonucleotides

Oral and rectal administration

Pulmonary administration

Targeted delivery to the CNS

High flow microinfusion into the brain parenchyma

Intracellular guidance by special techniques

Biochemical microinjection

Liposomes-mediated oligonucleotide delivery

Polyethylenimine-mediated oligonucleotide delivery

Delivery of TF Decoys

Biodegradable microparticles

Microparticles

Nanoparticles

siRNA delivery technologies

Local delivery of siRNA

In vivo delivery of siRNAs by synthetic vectors

Intracellular delivery of siRNAs

Protamine-antibody fusion proteins for delivery of siRNA to cells

Protein transduction domains

MPG-based delivery of siRNA

Delivery of siRNAs with aptamer-siRNA chimeras

Phosphorothioate stimulated cellular delivery of siRNA

Targeted delivery of siRNAs by lipid-based technologies

Delivery of siRNA-lipoplexes

Lipidoids for delivery of siRNAs

NeoLipid™ technology

siFECTamine

Systemic in vivo delivery of lipophilic siRNAs

Systemic delivery of siRNAi by lipid nanoparticles

Electroporation

Nucleofactor technology

Intravascular delivery of siRNA

27mer siRNA duplexes for improved delivery and potency

TransIT-TKO

DNA-based plasmids for delivery of siRNA

Convergent transcription

PCR cassettes expressing siRNAs

Genetically engineered bacteria for delivery of shRNA

Viral vectors for delivery of siRNA

Adenoviral vectors

Adeno-associated virus vectors for shRNA expression

Baculovirus vector

Lentiviral vectors

Retroviral delivery of siRNA

Transkingdom RNAi delivery by genetically engineered bacteria

Delivery of siRNA without a vector

Cell-penetrating peptides for delivery of siRNAs

Role of nanobiotechnology in siRNA delivery

Chitosan-coated nanoparticles for siRNA delivery

Delivery of gold nanorod-siRNA nanoplex to dopaminergic neurons

Lipidic aminoglycoside as siRNA nanocarrier

Lipid nanoparticles-mediated siRNA delivery

Nanosize liposomes for delivery of siRNA

PAMAM dendrimers for siRNA delivery

Polyethylenimine nanoparticles for siRNA delivery

Polycation-based nanoparticles for siRNA delivery

Quantum dots to monitor siRNA delivery

Targeted delivery of siRNAs to specific organs

siRNA delivery to the CNS

siRNA delivery to the liver

siRNAdelivery to the lungs

Control of RNAi and siRNA levels

siRNA pharmacokinetics in mammalian cells

Mathematical modeling for determining the dosing schedule of siRNA

Assessing siRNA pharmacodynamics in animal models

Research on siRNA delivery funded by the NIH

Companies involved in delivery technologies for siRNA

5.RNAi in Research

Introduction

Basic RNAi research

Genes and lifespan

Antiviral role of RNAi in animal cells

Silencing snoRNA genes

Profiling small RNAs

Study of signaling pathways

RNAi for research in neuroscience

Use of RNAi to study insulin action

Detection of cancer mutations

Loss-of-function genetic screens

Inducible and reversible RNAi

Combination of siRNA with green fluorescent protein

RNAi and environmental research

Applied RNAi research

RNAi for gene expression studies

Microarrays for measuring gene expression in RNAi

RNAi for functional genomic analysis

RNAi studies on C. elegans

RNAi studies on Drosophila

RNAi in planaria

Testing the specificity of RNAi

Tissue-specific RNAi

siRNA-mediated gene silencing

RNAi libraries

Universal plasmid siRNA library

pDual library using plasmid vector

pHippy plasmid vector library

siRNA libary including miRNAs

siRNA libraries using pRetroSuper vector

siRNA produced by enzymatic engineering of DNA

shRNA libraries

Enzymatic production of RNAi library

RNAi and alternative splicing

RNAi in animal development

RNAi for creating transgenic animals

RNAi for creating models of neurological disorders

Research support for RNAi in US

RNAi for toxicogenomics

Role of RNAi in the US biodefense research

The RNAi Consortium

Research support for RNAi in Europe

European Union for RNA Interference Technology

Research support of RNAi

Role of RNAi in MitoCheck project

RNAi Global Initiative

6.RNAi in drug discovery

Basis of RNAi for drug discovery

Use of siRNA libraries to identify genes as therapeutic targets

Role of siRNAs in drug target identification

Use of a genome-wide, siRNA library for drug discovery

Use of arrayed adenoviral siRNA libraries for drug discovery

RNAi as a tool for assay development

Targeting human kinases with an siRNAi library

Challenges of drug discovery with RNAi

Express TrackSM siRNA Drug Discovery Program

Genome-wide siRNA screens in mammalian cells

Natural antisense and ncRNA as drug targets

RNAi for target validation

Delivering siRNA for target validation in vivo

Off-target effects of siRNA-mediated gene silencing

Bioinformatic approach to off-target effects

Validation of oncology targets discovered through RNAi screens

Selection of siRNA versus shRNA for target validation

Application of RNAi to the druggable genome

Application of siRNA during preclinical drug development

siRNAs vs small molecules as drugs

siRNAs vs antisense drugs

RNAi technology in plants for drug discovery and development

Application of RNAi to poppy plant as source of new drugs

7.Therapeutic applications of RNAi

Introduction

Potential of RNAi-based therapies

In vitro applications of siRNA

In vivo applications of RNAi

RNAi and cell therapy

Gene inactivation to study hESCs

RNAi and stem cells

Cell therapy for immune disorders

RNAi gene therapy

Drug-inducible systems for control of gene expression

Potential side effects of RNAi gene therapy

Systemic delivery of siRNAs

In vivo RNAi therapeutic efficacy in animal models of human diseases

Virus infections

RNAi approaches to viral infections

Delivery of siRNAs in viral infections

RNAi applications in HIV

A multiple shRNA approach for silencing of HIV-1

Anti-HIV shRNA for AIDS lymphoma

Aptamer-mediated delivery of anti-HIV siRNAs

Bispecific siRNA constructs

Role of the nef gene during HIV-1 infection and RNAi

siRNA-directed inhibition of HIV-1 infection

Synergistic effect of snRNA and siRNA

Targeting CXCR4 with siRNAs

Targeting CCR5 with siRNAs

Concluding remarks on RNAi approach to HIV/AIDS

Influenza

Inhibition of influenza virus by siRNAs

Delivery of siRNA in influenza

Challenges and future prospects of siRNAs for influenza

Respiratory syncytial and parainfluenza viruses

Coronavirus/severe acute respiratory syndrome

Herpes simplex virus 2

Hepatitis B

Hepatitis C virus

Cytomegalovirus

siRNA vs antisense oligonucleotides for viral infections

siRNA against methicillin-resistant S. aureus

RNAi-based rational approach to antimalarial drug discovery

Inhibiting the growth of malarial parasite by heme-binding DNA aptamers

siRNA-based antimalarial therapeutics

RNAi applications in oncology

Inhibition of oncogenes

RNAi approach to study TRAIL

Modification of alternative splicing in cancer

Allele-specific inhibition

siRNAs for anticancer drug discovery

siRNAs for inducing cancer immunity

siRNAs for inhibition of angiogenesis

siRNA targeting the R2 subunit of ribonucleotide reductase

siRNA for cancer chemoprevention

Onconase

Drug delivery issues in managing cancer by RNAi approach

siHybrids vs siRNAs as anticancer agents

Nanobiotechnology-based delivery of siRNAs

Lipid nanoparticle-based delivery of anticancer siRNAs

Minicells for targeted delivery of nanoscale anticancer therapeutics

Nanoimmunoliposome-based system for targeted delivery of siRNA

Polymer nanoparticles for targeted delivery of anticancer siRNA

RNA nanotechnology for delivery of cancer therapeutics

Targeted delivery of a nanoparticle-siRNA complex in cancer patients

RNAi-based treatment of various cancer types

RNAi-based therapy of brain cancer

RNAi in breast cancer

Enhancing efficacy of hyperthermia/chemotherapy in cervical cancer

RNAi and colorectal cancer

RNAi and Ewing’s sarcoma

RNAi and leukemias

RNAi and lung cancer

RNAi and melanoma

RNAi and pancreatic cancer

RNAi and prostate cancer

Overcoming drug resistance in cancer

Targeting fusion proteins in cancer

Increasing chemosensitivity by RNAi

Genetic disorders

RNAi for skin disorders

Experimental studies for RNAi applications in skin disorders

Clinical applications of RNAi in skin disorders

Pachyonychia congenita

Neurological disorders

RNAi for neurodegenerative disorders

Alzheimer's disease

Parkinson's disease

Amyotrophic lateral sclerosis

Prion diseases

Polyglutamine-induced neurodegeneration

Fragile X syndrome and RNAi

RNAi-based therapy for Huntington's disease

Combination of RNAi and gene therapy to prevent neurodegenerative disease

Role of RNAi in pain therapy

Role of RNAi in repair of spinal cord injury

Role of RNAi in treatment of multiple sclerosis

siRNA for Duchenne muscular dystrophy

siRNA for dystonia

RNAi in ophthalmology

Age related macular degeneration

Current treatment of AMD

RNAi-based treatments for AMD

Diabetic retinopathy

Retinitis pigmentosa

RNAi and metabolic disorders

RNAi and obesity

Genes and regulation of body fat

RNAi and diabetes

Use of siRNAs to study glucose transporter

Use of RNAi to study genes in animal models of diabetes

RNAi for drug discovery in diabetes

A miRNA that regulates insulin secretion

RNAi in hematology

Stem cell-based gene therapy and RNAi for sickle cell disease

RNAi and disorders of the immune system

siRNA applications in immunology

Use of RNAi in transplantation

RNAi for cardiovascular disorders

RNAi for hypercholesterolemia

siRNA targeting NADPH oxidase in cardiovascular diseases

siRNA for study and treatment of ischemia-reperfusion injury

RNAi in respiratory disorders

siRNA for cystic fibrosis

siRNA for asthma

RNAi for musculoskeletal disorders

RNAi for rheumatoid arthritis

RNAi for bone disorders

RNAi for treatment of osteoporosis

Clinical trials of RNAi-based therapies

Improving efficacy of siRNAs for clinical trials by improved delivery

Role of RNAi in development of personalized medicine

Future prospects of RNAi

Challenges for the development of RNAi-based therapeutics

8.Safety, regulatory and patent issues

Introduction

Limitations and drawbacks of RNAi

Adverse effects of RNAi

Effect of siRNAs on interferon response

Detection of interferon response

Prevention of the interferon response in RNAi

Overcoming the innate immune response to siRNAs

Toxicity associated with RNAi

Selection of siRNAs to improve specificity and efficacy

Regulatory issues relevant to RNAi

RNAi patents

Companies with strong patent position

Alnylam

Benitec

Intradigm

Quark Pharmaceuticals

Sirna Therapeutics

9.Markets for RNAi Technologies

Introduction

Current and future market potential for RNAi technologies

RNAi reagents

RNAi-based drug discovery and target validation

RNAi-based development of therapeutics

RNAi market potential according to therapeutic areas

Market for viral infections

Market for cancer

Market for age related macular degeneration

Unmet needs in RNAi

Strategies for marketing RNAi

Choosing optimal indications

Strategies according to the trends in healthcare in the next decade

Concluding remarks

10.Companies involved in RNAi Technologies

Introduction

Major players in RNAi

Profiles of companies

Collaborations

11.References

Tables

Table 11: Classification of small RNA molecules

Table 12: Mechanisms of small RNAs involved in gene silencing......

Table 13: Historical landmarks in the evolution of RNAi......

Table 21: RNAi versus small molecules......

Table 22: Providers of software for siRNA design......

Table 23: Methods for the production of siRNAs......

Table 24: Advantages and limitations of methods of shRNA-derived siRNA knockdown......

Table 25: Comparison of eiRNA with siRNA......

Table 31: Methods for miRNA target prediction......

Table 32: miRNA expression in neurodegenerative diseases......

Table 33: Dysregulation of miRNA expression in epithelial cancers......

Table 34: Companies involved in miRNA diagnostics and therapeutics......

Table 41: Methods of delivery of oligonucleotides......

Table 42: Methods of delivery of siRNA......

Table 43: Companies developing siRNA delivery technologies......