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Critical Limb Ischemia-Pipeline Review, H1 2015

Critical Limb Ischemia-Pipeline Review, H1 2015


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Executive Summary

Critical Limb Ischemia-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Critical Limb Ischemia-Pipeline Review, H1 2015', provides an overview of the Critical Limb Ischemia's therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Critical Limb Ischemia, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Critical Limb Ischemia and special features on late-stage 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, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct's team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.

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

Scope

The report provides a snapshot of the global therapeutic landscape of Critical Limb Ischemia

The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved in the therapeutics development for Critical Limb Ischemia and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Critical Limb Ischemia products under development by companies and universities/research institutes based on information derived from company and industry-specific sources

Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages

A detailed assessment of monotherapy and combination therapy pipeline projects

Coverage of the Critical Limb Ischemia pipeline on the basis of target, MoA, route of administration and molecule type

Latest news and deals relating related to pipeline products

Reasons To Buy

Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Develop strategic initiatives by understanding the focus areas of leading companies

Identify and understand important and diverse types of therapeutics under development for Critical Limb Ischemia

Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

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

Table of Contents 2

List of Tables 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Critical Limb Ischemia Overview 9

Therapeutics Development 10

Pipeline Products for Critical Limb Ischemia-Overview 10

Pipeline Products for Critical Limb Ischemia-Comparative Analysis 11

Critical Limb Ischemia-Therapeutics under Development by Companies 12

Critical Limb Ischemia-Therapeutics under Investigation by Universities/Institutes 14

Critical Limb Ischemia-Pipeline Products Glance 15

Late Stage Products 15

Clinical Stage Products 16

Early Stage Products 17

Unknown 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

Bioheart, Inc. 25

DNAVEC Corporation 26

Hemostemix Ltd 27

IntelliCell BioSciences Inc. 28

Juventas Therapeutics, Inc. 29

Kasiak Research Pvt. Ltd. 30

Multi Gene Vascular Systems Ltd 31

NeoStem, Inc. 32

Pharmicell Co., Ltd. 33

Pluristem Therapeutics Inc. 34

ReNeuron Group plc 35

Stempeutics Research Private Limited 36

TikoMed AB 37

Vericel Corporation 38

ViroMed Co., Ltd. 39

Critical Limb Ischemia-Therapeutics Assessment 40

Assessment by Monotherapy Products 40

Assessment by Target 41

Assessment by Mechanism of Action 43

Assessment by Route of Administration 45

Assessment by Molecule Type 47

Drug Profiles 49

ACP-01-Drug Profile 49

Product Description 49

Mechanism of Action 49

R&D Progress 49

AdipoCell-Drug Profile 51

Product Description 51

Mechanism of Action 51

R&D Progress 51

Alecmestencel-T-Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

AMR-001-Drug Profile 54

Product Description 54

Mechanism of Action 54

R&D Progress 54

ASCT-01-Drug Profile 56

Product Description 56

Mechanism of Action 56

R&D Progress 56

Autologous Vascular Cells Therapy-Drug Profile 57

Product Description 57

Mechanism of Action 57

R&D Progress 57

beperminogene perplasmid-Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

Cell Therapy for Critical Limb Ischemia-Drug Profile 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

Cellgram for Severe Lower Limb Ischemia-Drug Profile 64

Product Description 64

Mechanism of Action 64

R&D Progress 64

DVC1-0101-Drug Profile 65

Product Description 65

Mechanism of Action 65

R&D Progress 65

Gene Therapy for Critical Limb Ischemia and Peripheral Arterial Disease-Drug Profile 66

Product Description 66

Mechanism of Action 66

R&D Progress 66

Gene Therapy to Activate Vascular Endothelial Growth Factor for Cardiovascular Disease and Central Nervous System Disorders-Drug Profile 67

Product Description 67

Mechanism of Action 67

R&D Progress 67

ixmyelocel-T-Drug Profile 68

Product Description 68

Mechanism of Action 68

R&D Progress 68

JVS-100-Drug Profile 71

Product Description 71

Mechanism of Action 71

R&D Progress 71

MultiGeneAngio-Drug Profile 73

Product Description 73

Mechanism of Action 73

R&D Progress 73

MultiStem-Drug Profile 74

Product Description 74

Mechanism of Action 74

R&D Progress 74

PLX-PAD-Drug Profile 77

Product Description 77

Mechanism of Action 77

R&D Progress 77

Protein for Myocardial Infarction and Critical Limb Ischemia-Drug Profile 81

Product Description 81

Mechanism of Action 81

R&D Progress 81

Recombinant Protein for Critical Limb Ischemia-Drug Profile 82

Product Description 82

Mechanism of Action 82

R&D Progress 82

Refacell-CLI-Drug Profile 83

Product Description 83

Mechanism of Action 83

R&D Progress 83

ReN-009-Drug Profile 84

Product Description 84

Mechanism of Action 84

R&D Progress 84

Stem Cell Therapy for Critical Limb Ischemia-Drug Profile 85

Product Description 85

Mechanism of Action 85

R&D Progress 85

Stem Cell Therapy for Critical Limb Ischemia-Drug Profile 86

Product Description 86

Mechanism of Action 86

R&D Progress 86

Stem Cell Therapy to Activate VEGF for Critical Limb Ischemia-Drug Profile 87

Product Description 87

Mechanism of Action 87

R&D Progress 87

Stempeucel-Drug Profile 88

Product Description 88

Mechanism of Action 88

R&D Progress 88

Stromal Cell Therapy for Critical Limb Ischemia-Drug Profile 91

Product Description 91

Mechanism of Action 91

R&D Progress 91

TM-700-Drug Profile 92

Product Description 92

Mechanism of Action 92

R&D Progress 92

VM-202-Drug Profile 93

Product Description 93

Mechanism of Action 93

R&D Progress 93

Critical Limb Ischemia-Recent Pipeline Updates 95

Critical Limb Ischemia-Dormant Projects 124

Critical Limb Ischemia-Discontinued Products 126

Critical Limb Ischemia-Product Development Milestones 127

Featured News & Press Releases 127

May 19, 2015: Hemostemix Receives Notice of Allowance for Additional U.S. Patent on ACP-01 Covering Autologous Cell Therapy for Critical Limb Ischemia 127

May 18, 2015: Significant Progress for Pluristem: PLX Cells Were Selected for European Medicines Agency's Adaptive Pathways Pilot Project 127

May 13, 2015: Pluristem's PLX Cells One Step Closer to Entering Japan's Accelerated Pathway for Regenerative Medicine 128

Apr 27, 2015: Stempeutics Gets Stem Cell Patent in China (Chinese Application Number: CN201080053627) for its Novel Stem Cell Drug Stempeucel 128

Apr 20, 2015: Hemostemix to Present at the 2015 Annual Meeting of the Clinical Trials Association in Israel 129

Apr 20, 2015: Pluristem's Clinical Advisory Board Prepares Phase II Clinical Trials in Critical Limb Ischemia in Europe and Japan 129

Mar 19, 2015: Hemostemix Expands Clinical Trial for Critical Limb Ischemia (CLI) to Four Sites in South Africa, Treats First South African Participant 130

Mar 06, 2015: Hemostemix Expands Clinical Trial for Treating Critical Limb Ischemia to the Peter Munk Cardiac Centre at Toronto General Hospital 130

Mar 04, 2015: Stempeutics receives US process patent for its novel stem cell drug Stempeucel 131

Feb 19, 2015: Cynata Achieves Major Stem Cell Manufacturing Milestone 131

Appendix 134

Methodology 134

Coverage 134

Secondary Research 134

Primary Research 134

Expert Panel Validation 134

Contact Us 134

Disclaimer 135

List of Tables

Number of Products under Development for Critical Limb Ischemia, H1 2015 10

Number of Products under Development for Critical Limb Ischemia-Comparative Analysis, H1 2015 11

Number of Products under Development by Companies, H1 2015 13

Number of Products under Investigation by Universities/Institutes, H1 2015 14

Comparative Analysis by Late Stage Development, H1 2015 15

Comparative Analysis by Clinical Stage Development, H1 2015 16

Comparative Analysis by Early Stage Development, H1 2015 17

Comparative Analysis by Unknown Stage Development, H1 2015 18

Products under Development by Companies, H1 2015 19

Products under Development by Companies, H1 2015 (Contd..1) 20

Products under Investigation by Universities/Institutes, H1 2015 21

Critical Limb Ischemia-Pipeline by AnGes MG, Inc., H1 2015 22

Critical Limb Ischemia-Pipeline by Apceth GmbH & Co. KG, H1 2015 23

Critical Limb Ischemia-Pipeline by Athersys, Inc., H1 2015 24

Critical Limb Ischemia-Pipeline by Bioheart, Inc., H1 2015 25

Critical Limb Ischemia-Pipeline by DNAVEC Corporation, H1 2015 26

Critical Limb Ischemia-Pipeline by Hemostemix Ltd, H1 2015 27

Critical Limb Ischemia-Pipeline by IntelliCell BioSciences Inc., H1 2015 28

Critical Limb Ischemia-Pipeline by Juventas Therapeutics, Inc., H1 2015 29

Critical Limb Ischemia-Pipeline by Kasiak Research Pvt. Ltd., H1 2015 30

Critical Limb Ischemia-Pipeline by Multi Gene Vascular Systems Ltd, H1 2015 31

Critical Limb Ischemia-Pipeline by NeoStem, Inc., H1 2015 32

Critical Limb Ischemia-Pipeline by Pharmicell Co., Ltd., H1 2015 33

Critical Limb Ischemia-Pipeline by Pluristem Therapeutics Inc., H1 2015 34

Critical Limb Ischemia-Pipeline by ReNeuron Group plc, H1 2015 35

Critical Limb Ischemia-Pipeline by Stempeutics Research Private Limited, H1 2015 36

Critical Limb Ischemia-Pipeline by TikoMed AB, H1 2015 37

Critical Limb Ischemia-Pipeline by Vericel Corporation, H1 2015 38

Critical Limb Ischemia-Pipeline by ViroMed Co., Ltd., H1 2015 39

Assessment by Monotherapy Products, H1 2015 40

Number of Products by Stage and Target, H1 2015 42

Number of Products by Stage and Mechanism of Action, H1 2015 44

Number of Products by Stage and Route of Administration, H1 2015 46

Number of Products by Stage and Molecule Type, H1 2015 48

Critical Limb Ischemia Therapeutics-Recent Pipeline Updates, H1 2015 95

Critical Limb Ischemia-Dormant Projects, H1 2015 124

Critical Limb Ischemia-Dormant Projects (Contd..1), H1 2015 125

Critical Limb Ischemia-Discontinued Products, H1 2015 126

List of Figures

Number of Products under Development for Critical Limb Ischemia, H1 2015 10

Number of Products under Development for Critical Limb Ischemia-Comparative Analysis, H1 2015 11

Number of Products under Development by Companies, H1 2015 12

Number of Products under Investigation by Universities/Institutes, H1 2015 14

Comparative Analysis by Late Stage Development, H1 2015 15

Comparative Analysis by Clinical Stage Development, H1 2015 16

Comparative Analysis by Early Stage Products, H1 2015 17

Comparative Analysis by Unknown Stage Development, H1 2015 18

Assessment by Monotherapy Products, H1 2015 40

Number of Products by Top 10 Targets, H1 2015 41

Number of Products by Stage and Top 10 Targets, H1 2015 42

Number of Products by Top 10 Mechanism of Actions, H1 2015 43

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 44

Number of Products by Top 10 Routes of Administration, H1 2015 45

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 46

Number of Products by Top 10 Molecule Types, H1 2015 47

Number of Products by Stage and Top 10 Molecule Types, H1 2015 48

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AnGes MG, Inc.

Apceth GmbH & Co. KG

Athersys, Inc.

Bioheart, Inc.

DNAVEC Corporation

Hemostemix Ltd

IntelliCell BioSciences Inc.

Juventas Therapeutics, Inc.

Kasiak Research Pvt. Ltd.

Multi Gene Vascular Systems Ltd

NeoStem, Inc.

Pharmicell Co., Ltd.

Pluristem Therapeutics Inc.

ReNeuron Group plc

Stempeutics Research Private Limited

TikoMed AB

Vericel Corporation

ViroMed Co., Ltd.

Critical Limb Ischemia Therapeutic Products under Development, Key Players in Critical Limb Ischemia Therapeutics, Critical Limb Ischemia Pipeline Overview, Critical Limb Ischemia Pipeline, Critical Limb Ischemia Pipeline Assessment


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