Oral Mucositis – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Oral Mucositis – Pipeline Review, H2 2016’, provides an overview of the Oral Mucositis pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Oral Mucositis, 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 Oral Mucositis 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 Oral Mucositis

The report reviews pipeline therapeutics for Oral Mucositis 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 Oral Mucositis therapeutics and enlists all their major and minor projects

The report assesses Oral Mucositis 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 Oral Mucositis

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 Oral Mucositis

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 Oral Mucositis 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

Aldeyra Therapeutics, Inc.

Cellceutix Corporation

Colby Pharmaceutical Company

Daewoong Pharmaceutical Co., Ltd.

Galera Therapeutics, Inc.

Onxeo SA

Oragenics, Inc.

Otsuka Holdings Co., Ltd.

Soligenix, Inc.

Spectrum Pharmaceuticals, Inc.

Spherium Biomed S.L.

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Oral Mucositis Overview 8

Therapeutics Development 9

Pipeline Products for Oral Mucositis - Overview 9

Pipeline Products for Oral Mucositis - Comparative Analysis 10

Oral Mucositis - Therapeutics under Development by Companies 11

Oral Mucositis - Therapeutics under Investigation by Universities/Institutes 12

Oral Mucositis - Pipeline Products Glance 13

Late Stage Products 13

Clinical Stage Products 14

Early Stage Products 15

Oral Mucositis - Products under Development by Companies 16

Oral Mucositis - Products under Investigation by Universities/Institutes 17

Oral Mucositis - Companies Involved in Therapeutics Development 18

Aldeyra Therapeutics, Inc. 18

Cellceutix Corporation 19

Colby Pharmaceutical Company 20

Daewoong Pharmaceutical Co., Ltd. 21

Galera Therapeutics, Inc. 22

Onxeo SA 23

Oragenics, Inc. 24

Otsuka Holdings Co., Ltd. 25

Soligenix, Inc. 26

Spectrum Pharmaceuticals, Inc. 27

Spherium Biomed S.L. 28

Oral Mucositis - Therapeutics Assessment 29

Assessment by Monotherapy Products 29

Assessment by Target 30

Assessment by Mechanism of Action 32

Assessment by Route of Administration 34

Assessment by Molecule Type 36

Drug Profiles 38

AG-013 - Drug Profile 38

Product Description 38

Mechanism Of Action 38

R&D Progress 38

brilacidin tetrahydrochloride - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

clonidine hydrochloride ER - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

dusquetide - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

GC-4419 - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

Gene Therapy for Oral Mucositis - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

Gene Therapy for Oral Mucositis - Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

KIN-219 - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

nepidermin - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

NS-2 - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

pralatrexate - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

rebamipide - Drug Profile 71

Product Description 71

Mechanism Of Action 71

R&D Progress 71

Recombinant Protein for Immunology, Dermatology, Oncology and Musculoskeletal Disorders - Drug Profile 73

Product Description 73

Mechanism Of Action 73

R&D Progress 73

SP-13004 - Drug Profile 74

Product Description 74

Mechanism Of Action 74

R&D Progress 74

Oral Mucositis - Dormant Projects 75

Oral Mucositis - Discontinued Products 78

Oral Mucositis - Product Development Milestones 79

Featured News & Press Releases 79

Jul 21, 2016: Cellceutix Expedites Phase 2 Trial of Brilacidin-OM For Oral Mucositis 79

Jun 06, 2016: Soligenix Announces Presentation of Phase 2 Oral Mucositis Clinical Trial Results at the 2016 Multinational Association for Supportive Care in Cancer Conference 79

Jun 06, 2016: Galera Therapeutics Announces Presentation at ASCO of Positive Results from Study of GC4419 for the Reduction of Severe Oral Mucositis 80

May 02, 2016: Oragenics Announces Positive Results from Confirmatory Animal Study of AG013 for Treatment of Oral Mucositis and Plans to Finalize Phase 2 Clinical Trial Protocol 81

Apr 14, 2016: Soligenix Announces Issuance of New Patents for Dusquetide 81

Jan 07, 2016: Galera Therapeutics Announces Fast Track Designation of GC4419 for Prevention of Oral Mucositis 82

Dec 21, 2015: SciClone To Pursue Development Of SGX942 In China Following Soligenix' Report Of Positive Phase 2 Preliminary Results In Oral Mucositis 83

Dec 16, 2015: Soligenix Announces Positive Preliminary Results from its Phase 2 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients 83

Dec 04, 2015: Soligenix Provides Clinical Program Updates on SGX942 for December 2015 85

Nov 25, 2015: FDA Grants Fast Track Designation to Cellceutix's Brilacidin-OM for Oral Mucositis 85

Oct 22, 2015: Onxeo Announces Data Demonstrating High Patient Compliance and Acceptability of Validive for Treatment of Severe Oral Mucositis 85

Oct 19, 2015: Onxeo Validive Abstract Accepted for Oral Presentation at ASTRO Annual Meeting 2015 86

Sep 09, 2015: Aldeyra Therapeutics to Present Novel Data on a Potential Treatment for Succinic Semi-Aldehyde Dehydrogenase Deficiency at the 2015 American Society of Human Genetics Annual Meeting 87

Aug 31, 2015: Soligenix Announces Completion of Patient Enrollment into its Phase 2 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients 87

Aug 03, 2015: Cellceutix Announces Ongoing Enrollment of Phase 2 Trial of Brilacidin for Oral Mucositis 88

Appendix 89

Methodology 89

Coverage 89

Secondary Research 89

Primary Research 89

Expert Panel Validation 89

Contact Us 89

Disclaimer 90

List of Tables

List of Tables

Number of Products under Development for Oral Mucositis, H2 2016 9

Number of Products under Development for Oral Mucositis – Comparative Analysis, H2 2016 10

Number of Products under Development by Companies, H2 2016 11

Number of Products under Investigation by Universities/Institutes, H2 2016 12

Comparative Analysis by Late Stage Development, H2 2016 13

Comparative Analysis by Clinical Stage Development, H2 2016 14

Comparative Analysis by Early Stage Development, H2 2016 15

Products under Development by Companies, H2 2016 16

Products under Investigation by Universities/Institutes, H2 2016 17

Oral Mucositis – Pipeline by Aldeyra Therapeutics, Inc., H2 2016 18

Oral Mucositis – Pipeline by Cellceutix Corporation, H2 2016 19

Oral Mucositis – Pipeline by Colby Pharmaceutical Company, H2 2016 20

Oral Mucositis – Pipeline by Daewoong Pharmaceutical Co., Ltd., H2 2016 21

Oral Mucositis – Pipeline by Galera Therapeutics, Inc., H2 2016 22

Oral Mucositis – Pipeline by Onxeo SA, H2 2016 23

Oral Mucositis – Pipeline by Oragenics, Inc., H2 2016 24

Oral Mucositis – Pipeline by Otsuka Holdings Co., Ltd., H2 2016 25

Oral Mucositis – Pipeline by Soligenix, Inc., H2 2016 26

Oral Mucositis – Pipeline by Spectrum Pharmaceuticals, Inc., H2 2016 27

Oral Mucositis – Pipeline by Spherium Biomed S.L., H2 2016 28

Assessment by Monotherapy Products, H2 2016 29

Number of Products by Stage and Target, H2 2016 31

Number of Products by Stage and Mechanism of Action, H2 2016 33

Number of Products by Stage and Route of Administration, H2 2016 35

Number of Products by Stage and Molecule Type, H2 2016 37

Oral Mucositis – Dormant Projects, H2 2016 75

Oral Mucositis – Dormant Projects (Contd..1), H2 2016 76

Oral Mucositis – Dormant Projects (Contd..2), H2 2016 77

Oral Mucositis – Discontinued Products, H2 2016 78

List of Figures

List of Figures

Number of Products under Development for Oral Mucositis, H2 2016 9

Number of Products under Development for Oral Mucositis – Comparative Analysis, H2 2016 10

Number of Products under Development by Companies, H2 2016 11

Comparative Analysis by Clinical Stage Development, H2 2016 14

Comparative Analysis by Early Stage Products, H2 2016 15

Assessment by Monotherapy Products, H2 2016 29

Number of Products by Targets, H2 2016 30

Number of Products by Stage and Targets, H2 2016 30

Number of Products by Mechanism of Actions, H2 2016 32

Number of Products by Stage and Mechanism of Actions, H2 2016 32

Number of Products by Routes of Administration, H2 2016 34

Number of Products by Stage and Routes of Administration, H2 2016 34

Number of Products by Molecule Types, H2 2016 36

Number of Products by Stage and Molecule Types, H2 2016 36

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