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"IntroductionAdvances in understanding the pathophysiology of spinal cord injury (SCI) over the past 2 decades have given rise to several therapeutic strategies that are presently being examined in Phase II/I clinical trials. Furthermore, President Obama's March 2009 decision to overturn restrictions on human embryonic stem cell research represents a new era in the field of spinal cord injuries.Scope*Analysis of the patient potential of spinal cord injury across the seven major markets and rest of world.*Review of key unmet clinical needs in the treatment of spinal cord injury and current pipeline treatments.*Identification of key opportunities and threats facing developers of treatments for spinal cord injury.*Insight from four internationally recognized key opinion leaders in the field of spinal cord injuries.HighlightsTherapeutic interventions for SCI need not necessarily provide a complete restoration of anatomic connections in order to lead to functional improvements and enhance patients' quality of life. Controversy continues to surround the use of methylprednisolone as an acute treatment for SCI, indicating a need for approved neuroprotective treatments.Alseres Pharmaceuticals's Cethrin (a recombinant fusion protein) has demonstrated a measurable effect on neurological recovery after SCI in a Phase I/IIa clinical trial. However, with its Phase II clinical program currently on hold, future development of Cethrin is uncertain.President Obama's March 2009 decision to lift restrictions on US federal funding for research involving human embryonic stem cells has provided developers with a greater deal of freedom with regards to research into SCI.Reasons to Purchase*Quantify the incidence of spinal cord injury and identify key clinical unmet needs.*Assess the opportunities and threats facing developers in the spinal cord injury market.*Utilize pipeline product profiles to identify potential in-licensing opportunities.
"Overview 1Catalyst 1Summary 1About Healthcare 2About the Central Nervous System pharmaceutical analysis team 2Executive Summary 3Strategic scoping and focus 3insight into the spinal cord injury market 3Upcoming reports 5Table of Contents 6Chapter 1 Spinal Cord Injury: Patient Potential 7Key findings 7Definition of spinal cord injury 8Classification of spinal cord injury 8Complete versus incomplete injury 9Tetraplegia and paraplegia 9ASIA Impairment Scale 9Etiology of spinal cord injury 10Road traffic accidents are the leading cause of SCI in developed countries 11Pathophysiology of spinal cord injury 12Primary injury 12Secondary injury 13Immediate phase 13Acute phase 13Intermediate phase 13Chronic phase 13Diagnosis of spinal cord injury 14Epidemiology of spinal cord injury 15Seven major markets 15New cases of spinal cord injury are expected to reach over 19,000 across the seven major markets in 2010 16Rest of the world 18Almost 4,000 new cases of spinal cord injury are projected each year in Russia between 2010 and 2020 20Epidemiological trends in spinal cord injury 21Gender: spinal cord injury predominantly affects men 21Age: most spinal cord injuries occur in young adults although the mean age at injury is increasing 22Mortality: life expectancies of SCI patients have increased due to advances in healthcare 24Economic consequences of spinal cord injury 25Chapter 2 Current Treatment Practices and Unmet Needs 27Key findings 27Current management of spinal cord injury 28Surgery 28Methylprednisolone is a pharmacological treatment option for acute spinal cord injury 29Rehabilitation 30Patient care path 31The acute hospital setting is the key intervention point for neuroprotective treatments 32For manufacturers of neurorestorative treatments, rehabilitation and community settings are key targets 32Further opportunities exist in the management of complications of SCI 33Unmet need in spinal cord injury 33Neurorestorative treatments 34Neuroprotective treatments 36Symptomatic treatments 37Greater efficacy of treatments for neuropathic pain 37Treatments for autonomic dysreflexia 41Improved treatments for spasticity 41Chapter 3 Market Potential 43Key findings 43 estimate of market potential 44Spinal cord injury: opportunities and threats 44Opportunities 45Eligibility for orphan drug/disease status 45Increasing R&D investment 47Treatments can command very high price points 48Specialized area maximizes sales and marketing force effectiveness 49Technology applications for other conditions 50Lifting of restrictions on human embryonic stem cell research in the US 51Prevalence of SCI is higher than previously believed 52Threats 53Safety concerns with stem cell therapies 53Potential reversal of US stem cell regulations 56Chapter 4 Pipeline Analysis 58Key findings 58Clinical trial design in spinal cord injury 59ICCP guidelines for the conduct of clinical trials in spinal cord injury 59Spontaneous recovery and statistical power 60Outcome measures: the ASIA impairment scale forms the standard measure 62Inclusion and exclusion criteria 63Clinical trial design 63Clinical pipeline overview 64Novartis represents the only Big Pharma company in the sparse clinical pipeline for SCI 64The pipeline is dominated by neurorestorative treatments for acute SCI 67Cethrin (BA-210; Alseres Pharmaceuticals) 68Drug profile: intraoperatively administered Rho GTPase protein inhibitor 68Development overview 69Cethrin's development program is currently suspended 69Phase I/IIa trial results: Cethrin has a measurable effect on neurological recovery after SCI 70Suspended Phase II trial 72Product positioning 73As the leading neuroregenerative pipeline candidate, Cethrin could be first to market 73SWOT analysis 74XP19986 (arbaclofen placarbil; Xenoport) 75Drug profile: GABAb receptor agonist in Phase II development for spasticity due to SCI 75Development overview 76Phase II trial results: 20mg and 30mg doses show significant improvements in muscle tone 76Product positioning 78XP19986 will be competing with generic baclofen 78Spasticity in SCI is expected to be the secondary indication for XP19986 79SWOT analysis 79ProCord (Proneuron Biotechnologies) 81Drug profile: autologous blood-derived macrophage therapy for the treatment of acute SCI 81Development overview 81Phase II development of ProCord is currently on hold 81Phase I study results demonstrate good tolerability in patients with acute SCI 83Product positioning 85ATI355 (reticulon 4 monoclonal antibody; Novartis AG) 85Drug profile: first human monoclonal antibody to neutralize Nogo-A 85Development overview 86Phase I multicenter trial is due to be completed in Q4 2010 86Product positioning 88As a neuroregenerative treatment for acute SCI, ATI355 will be in competition with Cethrin and ProCord 88Autologous Combination Stem Cell Therapy (TCA Cellular Therapy) 89SCI represents the least advanced indication for Autologous Combination Stem Cell Therapy 89Astrostem (RNL Bio) 89Human clinical study of Astrostem approved by Korean FDA in April 2009 89Neu2000 (Neurotech Pharmaceuticals) 90Improved locomotor outcomes associated with Neu2000 in rat model of moderate SCI 90Cordaneurin (Spinal Cord Therapeutics) 91Cordaneurin prevents the formation of growth inhibiting scars 91Preclinical pipeline overview 91Spinal Cord Therapeutics and SanBio represent key developers in the preclinical SCI pipeline 93Spinal Cord Therapeutics's two preclinical candidates are targeting chronically injured SCI patients 93SanBio's two SCI preclinical candidates are allogeneic donor cell treatments 94Initiation of world's first human clinical trial of embryonic stem cell-based therapy is expected in Q3 2010 95Neureva is presently seeking a co-development partner for NVA0011 (gacyclidine) 96Discontinued pipeline candidates for spinal cord injury 96The future of treatment in spinal cord injury 97Key opinion leaders view partially restorative therapies to be the most likely advance in the mid-term 97Combination treatments offer the greatest potential according to key opinion leaders 98Geographical availability of efficacious SCI treatments will be limited by expertise of physicians and cost 99Bibliography 101Books and journal papers 101Websites 112 reports 119Appendix 120Contributing experts 120Conferences attended 120Report methodology 120About 121About Healthcare 121About the Central Nervous System pharmaceutical analysis team 122Disclaimer 124List of Tables Table 1: ASIA impairment scale 10Table 2: Studies of the incidence of spinal cord injuries in the seven major markets 16Table 3: Incidence of spinal cord injury in the seven major markets, 2010-2020 (actual numbers) 18Table 4: Studies of the incidence of spinal cord injuries in the rest of the world 19Table 5: Incidence of spinal cord injury in the rest of world markets, 2010-2020 (actual numbers) 21Table 6: Average yearly healthcare and living expenses and estimated lifetime costs directly attributable to spinal cord injury 26Table 7: Studies of the prevalence of neuropathic pain in the spinal cord injury population 38Table 8: Results of published studies investigating the efficacy of oral pharmacological treatments in neuropathic spinal cord injury pain 40Table 9: Estimation of the US spinal cord injury market potential 44Table 10: Spinal cord injury market opportunities and threats 45
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