Critical Limb Ischemia – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Critical Limb Ischemia – Pipeline Review, H2 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

Companies mentioned

AnGes MG, Inc.

Apceth GmbH & Co. KG

Athersys, Inc.

BiogenCell Ltd.

Caladrius Biosciences Inc

Cynata Therapeutics Limited

Hemostemix Ltd

Histocell S.L.

ID Pharma Co., Ltd.

Integene International Holdings LLC

Juventas Therapeutics, Inc.

Kasiak Research Private Limited

Kowa Company, Ltd.

Neurofx, Inc.

Pharmicell Co., Ltd.

Pluristem Therapeutics Inc.

ReNeuron Group Plc

Symic Biomedical, Inc.

Targazyme, Inc.

TikoMed AB

U.S. Stem Cell, Inc.

Vericel Corporation

VESSL Therapeutics Ltd

ViroMed Co Ltd

Table of Contents

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 & Co. KG 23

Athersys, Inc. 24

BiogenCell Ltd. 25

Caladrius Biosciences Inc 26

Cynata Therapeutics Limited 27

Hemostemix Ltd 28

Histocell S.L. 29

ID Pharma Co., Ltd. 30

Integene International Holdings LLC 31

Juventas Therapeutics, Inc. 32

Kasiak Research Private Limited 33

Kowa Company, Ltd. 34

Neurofx, Inc. 35

Pharmicell Co., Ltd. 36

Pluristem Therapeutics Inc. 37

ReNeuron Group Plc 38

Symic Biomedical, Inc. 39

Targazyme, Inc. 40

TikoMed AB 41

U.S. Stem Cell, Inc. 42

Vericel Corporation 43

VESSL Therapeutics Ltd 44

ViroMed Co Ltd 45

Critical Limb Ischemia - Therapeutics Assessment 46

Assessment by Monotherapy Products 46

Assessment by Target 47

Assessment by Mechanism of Action 49

Assessment by Route of Administration 51

Assessment by Molecule Type 53

Drug Profiles 55

ACP-01 - Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

AdipoCell - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

Alecmestencel-T - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

ASCT-01 - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

BC-1 - Drug Profile 63

Product Description 63

Mechanism Of Action 63

R&D Progress 63

beperminogene perplasmid - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

Biologic to Activate FGF2 for Critical Limb Ischemia - Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

Cellgram-CLI - Drug Profile 71

Product Description 71

Mechanism Of Action 71

R&D Progress 71

CLBS-12 - Drug Profile 72

Product Description 72

Mechanism Of Action 72

R&D Progress 72

DVC-10101 - Drug Profile 73

Product Description 73

Mechanism Of Action 73

R&D Progress 73

FAB-117HC - Drug Profile 74

Product Description 74

Mechanism Of Action 74

R&D Progress 74

Gene Therapy for Critical Limb Ischemia - Drug Profile 75

Product Description 75

Mechanism Of Action 75

R&D Progress 75

ixmyelocel-T - Drug Profile 76

Product Description 76

Mechanism Of Action 76

R&D Progress 76

JVS-100 - Drug Profile 83

Product Description 83

Mechanism Of Action 83

R&D Progress 83

MultiGeneAngio - Drug Profile 88

Product Description 88

Mechanism Of Action 88

R&D Progress 88

NFx-101 - Drug Profile 89

Product Description 89

Mechanism Of Action 89

R&D Progress 89

NK-104 NP - Drug Profile 90

Product Description 90

Mechanism Of Action 90

R&D Progress 90

PF-05285401 - Drug Profile 91

Product Description 91

Mechanism Of Action 91

R&D Progress 91

PLX-PAD - Drug Profile 102

Product Description 102

Mechanism Of Action 102

R&D Progress 102

Protein to Agonize LRP5 and LRP6 for Critical Limb Ischemia and Myocardial Infarction - Drug Profile 112

Product Description 112

Mechanism Of Action 112

R&D Progress 112

Refacell-CLI - Drug Profile 113

Product Description 113

Mechanism Of Action 113

R&D Progress 113

Rejuveinix - Drug Profile 114

Product Description 114

Mechanism Of Action 114

R&D Progress 114

ReN-009 - Drug Profile 115

Product Description 115

Mechanism Of Action 115

R&D Progress 115

SB-030 - Drug Profile 117

Product Description 117

Mechanism Of Action 117

R&D Progress 117

Stem Cell Therapy for Cardiovacular Diseases and Asthma - Drug Profile 119

Product Description 119

Mechanism Of Action 119

R&D Progress 119

Stem Cell Therapy for Critical Limb Ischemia - Drug Profile 121

Product Description 121

Mechanism Of Action 121

R&D Progress 121

Stem Cell Therapy for Critical Limb Ischemia - Drug Profile 122

Product Description 122

Mechanism Of Action 122

R&D Progress 122

TM-700 - Drug Profile 123

Product Description 123

Mechanism Of Action 123

R&D Progress 123

TXA-302 - Drug Profile 124

Product Description 124

Mechanism Of Action 124

R&D Progress 124

TZ-101 - Drug Profile 125

Product Description 125

Mechanism Of Action 125

R&D Progress 125

VM-202 - Drug Profile 128

Product Description 128

Mechanism Of Action 128

R&D Progress 128

Critical Limb Ischemia - Dormant Projects 132

Critical Limb Ischemia - Discontinued Products 134

Critical Limb Ischemia - Product Development Milestones 135

Featured News & Press Releases 135

Oct 03, 2016: Hemostemix Announces it has been Granted two Additional Patents in the US and in Canada 135

Jun 20, 2016: AnGes Announces Amendment to the Global Development of HGF Plasmid for Critical Limb Ischemia 135

Apr 18, 2016: Hemostemix Receives IRB Approval from the Houston Methodist Hospital Research Institute and the University of California Los Angeles 136

Apr 18, 2016: Caladrius Reaches Agreement with Japanese Regulators on Development Plan for CD34 Cell Therapy for Critical Limb Ischemia 137

Jan 22, 2016: ViroMed Publishes Results from Critical Limb Ischemia Phase II Clinical Study 137

Dec 22, 2015: Hemostemix Poised to Expand Phase-2 Clinical Trial of Lead Product ACP-01 to the United States 138

Oct 05, 2015: Hemostemix to Present at 2015 Stem Cell Meeting on the Mesa 139

Sep 14, 2015: Hemostemix Executes Strategic Alliance with Hemostemix Asia for Expansion of Phase-2 Clinical Trial to Taiwan 140

Aug 12, 2015: Patient Enrollment Begins in Europe in the Global Phase III Clinical Trial of HGF Gene Therapy for Critical Limb Ischemia 140

Aug 10, 2015: Hemostemix Receives FDA Clearance for Phase-2 Clinical Trial of Lead Product ACP-01 in the United States 140

Jul 27, 2015: Hemostemix Enrolls 20th Participant and Treats 15th in International Clinical Trial for Critical Limb Ischemia 141

Jun 25, 2015: Hemostemix Enrolls Fifth Participant at Vancouver General Hospital in International Phase-2 Clinical Trial for Critical Limb Ischemia 141

Jun 18, 2015: Hemostemix Prepares Investigational New Drug Application for Review by U.S. Food and Drug Administration for Company’s ACP-01 Formulation to Treat Critical Limb Ischemia 142

May 19, 2015: Hemostemix Receives Notice of Allowance for Additional U.S. Patent on ACP-01 Covering Autologous Cell Therapy for Critical Limb Ischemia 142

Apr 20, 2015: Hemostemix to Present at the 2015 Annual Meeting of the Clinical Trials Association in Israel 143

Appendix 144

Methodology 144

Coverage 144

Secondary Research 144

Primary Research 144

Expert Panel Validation 144

Contact Us 144

Disclaimer 145

List of Tables

List of Tables

Number of Products under Development for Critical Limb Ischemia, H2 2016 11

Number of Products under Development for Critical Limb Ischemia – Comparative Analysis, H2 2016 12

Number of Products under Development by Companies, H2 2016 13

Number of Products under Development by Companies, H2 2016 (Contd..1) 14

Number of Products under Investigation by Universities/Institutes, H2 2016 15

Comparative Analysis by Late Stage Development, H2 2016 16

Comparative Analysis by Clinical Stage Development, H2 2016 17

Comparative Analysis by Early Stage Development, H2 2016 18

Products under Development by Companies, H2 2016 19

Products under Development by Companies, H2 2016 (Contd..1) 20

Products under Investigation by Universities/Institutes, H2 2016 21

Critical Limb Ischemia – Pipeline by AnGes MG, Inc., H2 2016 22

Critical Limb Ischemia – Pipeline by Apceth GmbH & Co. KG, H2 2016 23

Critical Limb Ischemia – Pipeline by Athersys, Inc., H2 2016 24

Critical Limb Ischemia – Pipeline by BiogenCell Ltd., H2 2016 25

Critical Limb Ischemia – Pipeline by Caladrius Biosciences Inc, H2 2016 26

Critical Limb Ischemia – Pipeline by Cynata Therapeutics Limited, H2 2016 27

Critical Limb Ischemia – Pipeline by Hemostemix Ltd, H2 2016 28

Critical Limb Ischemia – Pipeline by Histocell S.L., H2 2016 29

Critical Limb Ischemia – Pipeline by ID Pharma Co., Ltd., H2 2016 30

Critical Limb Ischemia – Pipeline by Integene International Holdings LLC, H2 2016 31

Critical Limb Ischemia – Pipeline by Juventas Therapeutics, Inc., H2 2016 32

Critical Limb Ischemia – Pipeline by Kasiak Research Private Limited, H2 2016 33

Critical Limb Ischemia – Pipeline by Kowa Company, Ltd., H2 2016 34

Critical Limb Ischemia – Pipeline by Neurofx, Inc., H2 2016 35

Critical Limb Ischemia – Pipeline by Pharmicell Co., Ltd., H2 2016 36

Critical Limb Ischemia – Pipeline by Pluristem Therapeutics Inc., H2 2016 37

Critical Limb Ischemia – Pipeline by ReNeuron Group Plc, H2 2016 38

Critical Limb Ischemia – Pipeline by Symic Biomedical, Inc., H2 2016 39

Critical Limb Ischemia – Pipeline by Targazyme, Inc., H2 2016 40

Critical Limb Ischemia – Pipeline by TikoMed AB, H2 2016 41

Critical Limb Ischemia – Pipeline by U.S. Stem Cell, Inc., H2 2016 42

Critical Limb Ischemia – Pipeline by Vericel Corporation, H2 2016 43

Critical Limb Ischemia – Pipeline by VESSL Therapeutics Ltd, H2 2016 44

Critical Limb Ischemia – Pipeline by ViroMed Co Ltd, H2 2016 45

Assessment by Monotherapy Products, H2 2016 46

Number of Products by Stage and Target, H2 2016 48

Number of Products by Stage and Mechanism of Action, H2 2016 50

Number of Products by Stage and Route of Administration, H2 2016 52

Number of Products by Stage and Molecule Type, H2 2016 54

Critical Limb Ischemia – Dormant Projects, H2 2016 132

Critical Limb Ischemia – Dormant Projects (Contd..1), H2 2016 133

Critical Limb Ischemia – Discontinued Products, H2 2016 134

List of Figures

List of Figures

Number of Products under Development for Critical Limb Ischemia, H2 2016 11

Number of Products under Development for Critical Limb Ischemia – Comparative Analysis, H2 2016 12

Number of Products under Development by Companies, H2 2016 13

Comparative Analysis by Clinical Stage Development, H2 2016 17

Comparative Analysis by Early Stage Products, H2 2016 18

Assessment by Monotherapy Products, H2 2016 46

Number of Products by Targets, H2 2016 47

Number of Products by Stage and Targets, H2 2016 47

Number of Products by Top 10 Mechanism of Actions, H2 2016 49

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 49

Number of Products by Top 10 Routes of Administration, H2 2016 51

Number of Products by Stage and Top 10 Routes of Administration, H2 2016 51

Number of Products by Molecule Types, H2 2016 53

Number of Products by Stage and Molecule Types, H2 2016 53

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