Abstract
Cytokines have drawn immense interest from the pharmaceutical industry over
the last two decades. Great effort has been devoted to finding ways to
reproduce their effects- or to block their activity- in the quest to create
novel drugs for cancer, infectious diseases, inflammatory and immune
disorders, and myelosuppression. Cytokine Therapies and Inhibitors: A
Vibrant Pipeline and Active Approved Market, a new CHI Advances Report,
takes a comprehensive look at the full range of cytokine therapies and
inhibitors, from products in research and development to products already
approved and marketed.
This report thoroughly evaluates the field of cytokines as it relates to drug development by providing:
- A description of cytokines and an explanation as to how they are classified
- In-depth coverage of approved and experimental cytokines and cytokine
inhibitors, including late clinical research news on some of the most
promising drugs in development
- Analysis of the interleukins, the interferons, the tumor necrosis factor
superfamily, transforming growth factor-beta, the hematopoietic growth
factors, and the chemokines, or chemotactic cytokines
- Discussion of efforts to develop improved versions of existing drugs
- Evaluation of the current and future markets for cytokine-based
therapeutics
Recombinant forms of natural cytokines were among the early success stories of
the biotech boom. Genetically engineered versions of interleukin-2,
interferon-alfa and -beta, erythropoietin, and the colony-stimulating factors
have now been available for years and remain profitable products for their
manufacturers.
In all, Cytokine Therapies and Inhibitors: A Vibrant Pipeline and Active
Approved Market examines more than 200 drugs and research programs,
ranging from cytokines to cytokine variants and agonists, from the approved
interleukin-2 drug Proleukin from Chiron/Novartis, for treating renal cell
carcinoma, to the interferon-omega drug candidate now in Phase II trials by
Intarcia Therapeutics, for treating hepatitis C virus. For example, one drug
discussed, Multikine from CEL-SCI, just received approval in January to go
into a Phase III trial to show that it can increase survival times for head
and neck cancer patients. The drug already has been shown to be nontoxic in
Phase II trials that also showed improvements in survival. The report also
evaluates cytokine inhibitors, from Amgen' s interleukin-1 receptor antagonist
Kineret, approved for treatment of rheumatoid arthritis to Abbott
Laboratories' interleukin-18 monoclonal antibody now in Phase I research for
autoimmune disorders.
The market for cytokine-based therapeutics holds great promise. Sales in 2005
for 13 of the 35 cytokine drugs already approved amounted to more than $1
billion each. Centocor/Johnson & Johnson' s Remicade alone racked up sales of
almost $3.5 billion in 2005. Perhaps the biggest market of all is anemia,
where recombinant erythropoietin drugs boasted sales of more than $10 billion
in 2005.
Cytokine Therapies and Inhibitors: A Vibrant Pipeline and Active Approved
Market is an indispensable report for individuals directly involved in the
research and development, licensing, or marketing of cytokine-based therapies.
Table of Contents
CHAPTER 1
BACKGROUND AND SCIENTIFIC OVERVIEW: CYTOKINES ARE INTRACELLULAR MESSENGERS THAT REGULATE THE IMMUNE SYSTEM
- 1.1. What Are Cytokines?
- [SIDEBAR]
- The Immune System
- 1.2. Classification of Cytokines
- Interleukins
- Interferons
- Tumor Necrosis Factors
- Transforming Growth Factor-beta
- Colony-Stimulating Factors
- Chemokines
CHAPTER 2
CYTOKINE THERAPEUTICS: ADMINISTERING CYTOKINES AS DRUGS
- 2.1. Interleukins
- Interleukin-1
- Aldesleukin
- Denileukin Diftitox
- BAY 50-4798
- Multikine
- IRX-2/IRX-3/IRX-4/IRX-5/IRX-6
- EMD 273063/EMD 273066
- TG 4010/TG 4001
- IL-2 XL
- IL-2/EP
- Liposomal IL-2
- Sangamo BioSciences' Technology
- Others
- Interleukin-3
- Interleukin-4
- PRX321
- Interleukin-6
- Interleukin-7
- IL-7
- Interleukin-10
- Interleukin-11
- Oprelvekin
- PEGylated IL-11
- Interleukin-12
- EGEN-001
- AS1409
- TDS/IL-12
- CYT-41000
- Interleukin-13
- Cintredekin Besudotox
- Uvidem/Collidem
- Glioblast-13
- Interleukin-18
- Iboctadekin
- IL-18 Plasmids
- Interleukin-21
- IL-21
- Interleukin-29
- IL-29
- 2.2. Interferons
- Interferon a
- Intron A/Rebetron/PEG-Intron
- Roferon-A/Pegasys
- Infergen
- Alferon N/Alferon LDO
- Multiferon
- Albuferon
- Oral IFN-a
- Topical IFN-a
- IFN-a-2b XL
- HCV-I.E.T
- Locteron/BLX-883
- Oroferone
- Maxy-alpha
- Neoferon
- Belerofon
- Ambrx' s Enhanced Pegylated IFN-a
- Ultra Interferons
- PEGylated IFN-a
- Interferon beta
- Betaferon/Betaseron
- Avonex
- Rebif
- MS-I.E.T.
- IFN-beta- Fc
- TDS/IFN-beta
- Others
- Interferon
- Actimmune
- TG 1042 (Ad-IFN gamma)
- Others
- Other Interferons
- Tauferon
- IFN-omega
- 2.3. Tumor Necrosis Factors
- TNF-a
- Aurimune (CYT-6091)/AuriTol (CYT-21001)
- OncoVEXTNF-a
- TRAIL
- Rh-Apo2L
- Apo2L/TRAIL (AMG 951)
- HGS-ETR1/HGS-ETR2/HGS-TR2J
- AMG 655
- 4-1BBL
- BMS-663513
- GTC Biotherapeutics' Compound
- 2.4. Hematopoietic Growth Factors
- Erythropoietin
- Epoetin a/Aranesp
- Epoetin beta/CERA
- Epoetin delta
- Hematide
- FG-2216/FG-4592
- GlycoPEG-EPO
- EPO-Fc
- PT-401
- MOD-701
- Albupoietin
- Repoxygen
- Tissue-Protective Cytokines
- Granulocyte Colony-Stimulating Factor
- Filgrastim /Pegfilgrastim
- Lenograstim
- Nartograstim
- Telintra
- AX200
- Maxy-G34
- GlycoPEG-GCSF
- Others
- Granulocyte-Macrophage Colony-Stimulating Factor
- Sargramostim
- Molgramostim
- Leucotropin
- CTCE-0214/CTCE-0324
- Sangamo BioSciences' Technology
- Macrophage Colony-Stimulating Factor
- Mirimostim
- Stem Cell Factor
- Ancestim
- Thrombopoietin
- AMG 531
- Eltrombopag
- Thromboplus
- c-Mpl Minibody Agonists
- 2.5. Chemokines
CHAPTER 3
CYTOKINE INHIBITORS: DRUGS THAT BLOCK CYTOKINE ACTIVITY
- 3.1. Interleukin Inhibitors
- Interleukin-1
- Anakinra
- IL-1 Trap
- AMG 108
- ACZ885
- Interleukin-2
- Daclizumab
- Basiliximab
- MT204
- Interleukin-4 and -13
- Aerovant/Aeroderm/Aerolast
- AMG 317
- CAT-354
- TNX-650
- ISIS 369645
- DOM1000P/DOM0910
- Zenyth Therapeutics/Merck' s Compounds
- Sirna Therapeutics/GlaxoSmithKline' s Compounds
- Targepeutics' Compounds
- Interleukin-5
- Mepolizumab
- BIW-8405
- YM-90709
- Interleukin-6
- Tocilizumab
- C326
- Interleukin-9
- MEDI-528
- Interleukin-12 and -23
- CNTO 1275
- ABT-874
- STA-5326
- Anti-IL-23 Aptimers
- Interleukin-15
- AMG 714
- CRB-15
- Other Interleukins
- Centocor Research
- ZymoGenetics/Serono/Novo Nordisk Research
- 3.2. Interferon Inhibitors
- Interferon a
- MEDI-545/MEDI-546
- Interferon gamma
- HuZAF
- Advanced Biotherapies' Anti-IFN-gamma Antibodies
- 3.3. Tumor Necrosis Factor Inhibitors
- TNF-a
- Etanercept
- Infliximab
- Adalimumab
- Certolizumab Pegol
- CNTO 148
- CytoFab
- CC-10004
- ALS-00T2
- tgAAC94
- XPro 1595
- MP8
- DOM0200/DOM0100
- Ablynx' s Nanobodies
- Nastech Pharmaceutical' s Compounds
- Devgen' s Compounds
- Lymphotoxin-beta
- Biogen Idec' s Compounds
- BLyS
- Belimumab
- Atacicept
- AMG 623
- BR3-Fc
- Xencor' s Compound
- RANKL
- Denosumab
- PX 107
- Others
- CD40L
- SGN-40
- CHIR 12.12
- Biogen Idec/UCB' s Compound
- CD30L
- MDX-060
- SGN-30/SGN-35
- XmAb 2513
- LIGHT
- CoGenesys' s Compound
- TWEAK
- Biogen Idec' s Research
- 3.4. Transforming Growth Factor-beta Inhibitors
- AP 12009/AP 11014
- GC-1008
- Anti-TGF-beta2 Aptimers
- TGF-beta Receptor Inhibitors
- 3.5. Colony-Stimulating Factor Inhibitors
- G-CSF
- Zenyth Therapeutics/MuriGen Therapeutics' Compounds
- GM-CSF
- KM002
- CAM-3001
- MT203
- 3.6. Chemokine Antagonists
- CCR1
- MLN3897, MLN3701
- PS375179
- ChemoCentryx' s Compounds
- CCR2
- MLN1202
- INCB3284/INCB8696
- ABN912
- CCX915
- Telik' s Compound
- CCR3
- CCR5
- Maraviroc
- Vicriviroc
- PRO 140
- INCB9471/INCB15050
- HGS004/HGS101
- Sangamo BioSciences' Technology
- Others
- CCR9
- Traficet-EN
- CXCR1/ CXCR2
- PS291822
- 656933
- PAC-G31P
- Others
- CXCR3
- MDX-1100
- AMG 487
- CoGenesys' s Compound
- CXCR4
- Mozobil
- AMD070
- CTCE-9908
- ChemoCentryx' s Compounds
- Others
- CXCR6
- CoGenesys' s Compound
- MIF
- HMGB
- MedImmune/Critical Therapeutics' Compounds
CHAPTER 4
BUSINESS AND STRATEGIC OUTLOOK: MARKET POTENTIAL FOR CYTOKINE THERAPEUTICS
- 4.1. The Market for Cytokine-Based Drugs
- 4.2. Selected Markets
- Cancer and Cytopenias
- Cancer
- Anemia
- Neutropenia
- Thrombocytopenia
- Immune and Inflammatory Diseases
- Rheumatoid Arthritis
- Crohn' s Disease
- Psoriasis
- Lupus
- Multiple Sclerosis
- Asthma
- Chronic Obstructive Pulmonary Disease
- Infectious Diseases
- HIV
- Hepatitis C Virus
REFERENCES
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