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Critical Limb Ischemia - Pipeline Review, H1 2016

  • May 2016
  • -
  • Global Markets Direct
  • -
  • 150 pages

Critical Limb Ischemia - Pipeline Review, H1 2016

Summary

Global Markets Direct’s, ‘Critical Limb Ischemia - Pipeline Review, H1 2016’, provides an overview of the Critical Limb Ischemia pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Critical Limb Ischemia, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Critical Limb Ischemia and features dormant and discontinued projects.

Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data.

Scope

- The report provides a snapshot of the global therapeutic landscape of Critical Limb Ischemia
- The report reviews pipeline therapeutics for Critical Limb Ischemia by companies and universities/research institutes based on information derived from company and industry-specific sources
- The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages
- The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities
- The report reviews key players involved Critical Limb Ischemia therapeutics and enlists all their major and minor projects
- The report assesses Critical Limb Ischemia therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type
- The report summarizes all the dormant and discontinued pipeline projects
- The report reviews latest news related to pipeline therapeutics for Critical Limb Ischemia

Reasons to buy

- Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies
- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
- Identify and understand important and diverse types of therapeutics under development for Critical Limb Ischemia
- Identify potential new clients or partners in the target demographic
- Develop strategic initiatives by understanding the focus areas of leading companies
- Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics
- Devise corrective measures for pipeline projects by understanding Critical Limb Ischemia pipeline depth and focus of Indication therapeutics
- Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope
- Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline

Table Of Contents

Critical Limb Ischemia - Pipeline Review, H1 2016
Table of Contents
Table of Contents 2
List of Tables 7
List of Figures 8
Introduction 9
Global Markets Direct Report Coverage 9
Critical Limb Ischemia Overview 10
Therapeutics Development 11
Pipeline Products for Critical Limb Ischemia - Overview 11
Pipeline Products for Critical Limb Ischemia - Comparative Analysis 12
Critical Limb Ischemia - Therapeutics under Development by Companies 13
Critical Limb Ischemia - Therapeutics under Investigation by Universities/Institutes 15
Critical Limb Ischemia - Pipeline Products Glance 16
Late Stage Products 16
Clinical Stage Products 17
Early Stage Products 18
Critical Limb Ischemia - Products under Development by Companies 19
Critical Limb Ischemia - Products under Investigation by Universities/Institutes 21
Critical Limb Ischemia - Companies Involved in Therapeutics Development 22
AnGes MG, Inc. 22
Apceth GmbH and Co. KG 23
Athersys, Inc. 24
Caladrius Biosciences, Inc. 25
Cynata Therapeutics Limited 26
Hemostemix Ltd 27
Histocell S.L. 28
ID Pharma Co., Ltd. 29
IntelliCell BioSciences Inc. 30
Juventas Therapeutics, Inc. 31
Kasiak Research Private Limited 32
Kowa Company, Ltd. 33
Multi Gene Vascular Systems Ltd 34
Pharmicell Co., Ltd. 35
Pluristem Therapeutics Inc. 36
ReNeuron Group Plc 37
Stempeutics Research Private Limited 38
Targazyme, Inc. 39
TikoMed AB 40
U.S. Stem Cell, Inc. 41
Vericel Corporation 42
ViroMed Co., Ltd. 43
Critical Limb Ischemia - Therapeutics Assessment 44
Assessment by Monotherapy Products 44
Assessment by Target 45
Assessment by Mechanism of Action 47
Assessment by Route of Administration 49
Assessment by Molecule Type 51
Drug Profiles 53
ACP-01 - Drug Profile 53
Product Description 53
Mechanism of Action 53
RandD Progress 53
AdipoCell - Drug Profile 55
Product Description 55
Mechanism of Action 55
RandD Progress 55
Alecmestencel-T - Drug Profile 57
Product Description 57
Mechanism of Action 57
RandD Progress 57
ASCT-01 - Drug Profile 58
Product Description 58
Mechanism of Action 58
RandD Progress 58
beperminogene perplasmid - Drug Profile 59
Product Description 59
Mechanism of Action 59
RandD Progress 59
Biologic to Activate FGF2 for Critical Limb Ischemia - Drug Profile 64
Product Description 64
Mechanism of Action 64
RandD Progress 64
Cellgram-CLI - Drug Profile 65
Product Description 65
Mechanism of Action 65
RandD Progress 65
CLBS-12 - Drug Profile 66
Product Description 66
Mechanism of Action 66
RandD Progress 66
DVC-10101 - Drug Profile 67
Product Description 67
Mechanism of Action 67
RandD Progress 67
Gene Therapy for Critical Limb Ischemia - Drug Profile 69
Product Description 69
Mechanism of Action 69
RandD Progress 69
HC-016 - Drug Profile 70
Product Description 70
Mechanism of Action 70
RandD Progress 70
ixmyelocel-T - Drug Profile 71
Product Description 71
Mechanism of Action 71
RandD Progress 71
JVS-100 - Drug Profile 74
Product Description 74
Mechanism of Action 74
RandD Progress 74
MultiGeneAngio - Drug Profile 76
Product Description 76
Mechanism of Action 76
RandD Progress 76
PF-05285401 - Drug Profile 77
Product Description 77
Mechanism of Action 77
RandD Progress 77
pitavastatin NP - Drug Profile 82
Product Description 82
Mechanism of Action 82
RandD Progress 82
PLX-PAD - Drug Profile 83
Product Description 83
Mechanism of Action 83
RandD Progress 83
Protein to Agonize LRP5 and LRP6 for Critical Limb Ischemia and Myocardial Infarction - Drug Profile 87
Product Description 87
Mechanism of Action 87
RandD Progress 87
Refacell-CLI - Drug Profile 88
Product Description 88
Mechanism of Action 88
RandD Progress 88
Rejuveinix - Drug Profile 89
Product Description 89
Mechanism of Action 89
RandD Progress 89
ReN-009 - Drug Profile 90
Product Description 90
Mechanism of Action 90
RandD Progress 90
Stem Cell Therapy for Cardiovacular Diseases - Drug Profile 92
Product Description 92
Mechanism of Action 92
RandD Progress 92
Stem Cell therapy for CNS, CVS, Dermatological, Immunological and Metabolic Disorders - Drug Profile 93
Product Description 93
Mechanism of Action 93
RandD Progress 93
Stem Cell Therapy for Critical Limb Ischemia - Drug Profile 94
Product Description 94
Mechanism of Action 94
RandD Progress 94
Stem Cell Therapy for Critical Limb Ischemia - Drug Profile 95
Product Description 95
Mechanism of Action 95
RandD Progress 95
Stem Cell Therapy for Critical Limb Ischemia - Drug Profile 96
Product Description 96
Mechanism of Action 96
RandD Progress 96
Stempeucel - Drug Profile 97
Product Description 97
Mechanism of Action 97
RandD Progress 97
TM-700 - Drug Profile 100
Product Description 100
Mechanism of Action 100
RandD Progress 100
TXA-302 - Drug Profile 101
Product Description 101
Mechanism of Action 101
RandD Progress 101
TZ-101 - Drug Profile 103
Product Description 103
Mechanism of Action 103
RandD Progress 103
VM-202 - Drug Profile 105
Product Description 105
Mechanism of Action 105
RandD Progress 105
Critical Limb Ischemia - Recent Pipeline Updates 107
Critical Limb Ischemia - Dormant Projects 140
Critical Limb Ischemia - Discontinued Products 142
Critical Limb Ischemia - Product Development Milestones 143
Featured News and Press Releases 143
Apr 18, 2016: Hemostemix Receives IRB Approval from the Houston Methodist Hospital Research Institute and the University of California Los Angeles 143
Apr 18, 2016: Caladrius Reaches Agreement with Japanese Regulators on Development Plan for CD34 Cell Therapy for Critical Limb Ischemia 143
Jan 22, 2016: ViroMed Publishes Results from Critical Limb Ischemia Phase II Clinical Study 144
Dec 22, 2015: Hemostemix Poised to Expand Phase-2 Clinical Trial of Lead Product ACP-01 to the United States 145
Dec 21, 2015: Pluristem Reaches Agreement with Japan's PMDA on Protocol for Final Trial Targeting Market Entry via Accelerated Pathway 145
Oct 05, 2015: Hemostemix to Present at 2015 Stem Cell Meeting on the Mesa 146
Sep 14, 2015: Hemostemix Executes Strategic Alliance with Hemostemix Asia for Expansion of Phase-2 Clinical Trial to Taiwan 147
Aug 17, 2015: Pluristem Granted U.S. Patent for Production Methods and Use of Placental Cell Therapy in a Range of Indications 147
Aug 12, 2015: Patient Enrollment Begins in Europe in the Global Phase III Clinical Trial of HGF Gene Therapy for Critical Limb Ischemia 148
Aug 12, 2015: Japan Grants Safety Clearance to Pluristem's PLX-PAD Cells for Use in Clinical Trials 148
Appendix 149
Methodology 149
Coverage 149
Secondary Research 149
Primary Research 149
Expert Panel Validation 149
Contact Us 149
Disclaimer 150

List of Tables
Number of Products under Development for Critical Limb Ischemia, H1 2016 11
Number of Products under Development for Critical Limb Ischemia - Comparative Analysis, H1 2016 12
Number of Products under Development by Companies, H1 2016 13
Number of Products under Development by Companies, H1 2016 (Contd..1) 14
Number of Products under Investigation by Universities/Institutes, H1 2016 15
Comparative Analysis by Late Stage Development, H1 2016 16
Comparative Analysis by Clinical Stage Development, H1 2016 17
Comparative Analysis by Early Stage Development, H1 2016 18
Products under Development by Companies, H1 2016 19
Products under Development by Companies, H1 2016 (Contd..1) 20
Products under Investigation by Universities/Institutes, H1 2016 21
Critical Limb Ischemia - Pipeline by AnGes MG, Inc., H1 2016 22
Critical Limb Ischemia - Pipeline by Apceth GmbH and Co. KG, H1 2016 23
Critical Limb Ischemia - Pipeline by Athersys, Inc., H1 2016 24
Critical Limb Ischemia - Pipeline by Caladrius Biosciences, Inc. , H1 2016 25
Critical Limb Ischemia - Pipeline by Cynata Therapeutics Limited, H1 2016 26
Critical Limb Ischemia - Pipeline by Hemostemix Ltd, H1 2016 27
Critical Limb Ischemia - Pipeline by Histocell S.L., H1 2016 28
Critical Limb Ischemia - Pipeline by ID Pharma Co., Ltd., H1 2016 29
Critical Limb Ischemia - Pipeline by IntelliCell BioSciences Inc., H1 2016 30
Critical Limb Ischemia - Pipeline by Juventas Therapeutics, Inc., H1 2016 31
Critical Limb Ischemia - Pipeline by Kasiak Research Private Limited, H1 2016 32
Critical Limb Ischemia - Pipeline by Kowa Company, Ltd., H1 2016 33
Critical Limb Ischemia - Pipeline by Multi Gene Vascular Systems Ltd, H1 2016 34
Critical Limb Ischemia - Pipeline by Pharmicell Co., Ltd., H1 2016 35
Critical Limb Ischemia - Pipeline by Pluristem Therapeutics Inc., H1 2016 36
Critical Limb Ischemia - Pipeline by ReNeuron Group Plc, H1 2016 37
Critical Limb Ischemia - Pipeline by Stempeutics Research Private Limited, H1 2016 38
Critical Limb Ischemia - Pipeline by Targazyme, Inc., H1 2016 39
Critical Limb Ischemia - Pipeline by TikoMed AB, H1 2016 40
Critical Limb Ischemia - Pipeline by U.S. Stem Cell, Inc., H1 2016 41
Critical Limb Ischemia - Pipeline by Vericel Corporation, H1 2016 42
Critical Limb Ischemia - Pipeline by ViroMed Co., Ltd., H1 2016 43
Assessment by Monotherapy Products, H1 2016 44
Number of Products by Stage and Target, H1 2016 46
Number of Products by Stage and Mechanism of Action, H1 2016 48
Number of Products by Stage and Route of Administration, H1 2016 50
Number of Products by Stage and Molecule Type, H1 2016 52
Critical Limb Ischemia Therapeutics - Recent Pipeline Updates, H1 2016 107
Critical Limb Ischemia - Dormant Projects, H1 2016 140
Critical Limb Ischemia - Dormant Projects (Contd..1), H1 2016 141
Critical Limb Ischemia - Discontinued Products, H1 2016 142

List of Figures
Number of Products under Development for Critical Limb Ischemia, H1 2016 11
Number of Products under Development for Critical Limb Ischemia - Comparative Analysis, H1 2016 12
Number of Products under Development by Companies, H1 2016 13
Comparative Analysis by Late Stage Development, H1 2016 16
Comparative Analysis by Clinical Stage Development, H1 2016 17
Comparative Analysis by Early Stage Products, H1 2016 18
Assessment by Monotherapy Products, H1 2016 44
Number of Products by Targets, H1 2016 45
Number of Products by Stage and Targets, H1 2016 45
Number of Products by Mechanism of Actions, H1 2016 47
Number of Products by Stage and Mechanism of Actions, H1 2016 47
Number of Products by Top 10 Routes of Administration, H1 2016 49
Number of Products by Stage and Top 10 Routes of Administration, H1 2016 49
Number of Products by Molecule Types, H1 2016 51
Number of Products by Stage and Top 10 Molecule Types, H1 2016 51

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