Critical Limb Ischemia - Pipeline Review, H2 2016

Published: Nov, 2016 | Pages: 145 | Publisher: Global Markets Direct
Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

Summary

Global Markets Direct's latest Pharmaceutical and Healthcare disease pipeline guide Critical Limb Ischemia - Pipeline Review, H2 2016, provides an overview of the Critical Limb Ischemia (Cardiovascular) pipeline landscape.

Critical limb ischemia (CLI) is the most severe form of peripheral arterial disease (PAD). It is caused by chronic inflammatory processes associated with atherosclerosis that result in reduced blood flow to the legs, feet and hands. Symptoms include pain or numbness in feet or toes, sores, skin infections will not heal. Treatment goals for CLI include reducing the number of cardiovascular risk factors (such as quitting smoking and reduction of cholesterol), relieving pain, healing ulcers, preventing major amputation, improving quality of life and increasing survival.

Report Highlights

Global Markets Direct's Pharmaceutical and Healthcare latest pipeline guide Critical Limb Ischemia - Pipeline Review, H2 2016, provides comprehensive information on the therapeutics under development for Critical Limb Ischemia (Cardiovascular), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases.

The Critical Limb Ischemia (Cardiovascular) pipeline guide also reviews of key players involved in therapeutic development for Critical Limb Ischemia and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Phase III, Phase II, Phase I, Preclinical and Discovery stages are 2, 11, 4, 12 and 1 respectively. Similarly, the Universities portfolio in Preclinical stages comprises 1 molecules, respectively.Critical Limb Ischemia.

Critical Limb Ischemia (Cardiovascular) pipeline guide 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. The guide 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. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

Note: Certain content / sections in the pipeline guide may be removed or altered based on the availability and relevance of data.

Scope

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

Reasons To Buy

- Procure strategically important competitor information, analysis, and insights to formulate effective R&D strategies.
- Recognize emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage.
- Find and recognize significant and varied types of therapeutics under development for Critical Limb Ischemia (Cardiovascular).
- Classify potential new clients or partners in the target demographic.
- Develop tactical initiatives by understanding the focus areas of leading companies.
- Plan mergers and acquisitions meritoriously by identifying key players and it's most promising pipeline therapeutics.
- Formulate corrective measures for pipeline projects by understanding Critical Limb Ischemia (Cardiovascular) 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.
- Adjust the therapeutic portfolio by recognizing discontinued projects and understand from the know-how what drove them from pipeline.

 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

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