PPT Slide

SygenÆ (monosialotetrahexosylganglioside GM-1)

SygenÆ (GM-1 Ganglioside)

Maryland GM-1 Acute SCI Trial

SygenÆ (GM-1) Acute SCI Study Design

SygenÆ (GM-1) Acute SCI Study Design (contíd)

SygenÆ (GM-1) Acute SCI Study Operational Aspects

ASIA Impairment Scale (AIS) (Pre-Treatment Only)

Modified Benzel Classification (Weeks 4, 8, 16, 26, and 52 F/U)

Modified Benzel Classification (cont.) (Weeks 4, 8, 16, 26, and 52 F/U)

Major Improvement Criterion: AIS/Benzel Neurologic Improvement

Pre-planned Primary Outcome Measures

Pre-planned Secondary Outcome Measures and Analyses

SygenÆ (GM-1) Acute SCI Study Size and Duration

Enrollment in the SygenÆ (GM-1) Acute SCI Study

Patient Accounting

Analysis Group (n=760)

Safety Data Summary

Survival by Treatment Group (47 Deaths in 797 Patients)

Population Characteristics

Week 26 Major AIS/Benzel Improvers by Baseline AIS Strata and Level

Week 26 Benzel Outcome Grade by Baseline AIS Strata

Week 26 Major AIS/Benzel Improvers by Baseline AIS Strata and MPSS Timing

Patient Enrollment by Treatment Group and Strata: Age, Level, Baseline AIS

Major (2 Grade AIS/Benzel) Improvers by Visit

Baseline A

Baseline B

Baseline C+D

Operated (n=521) vs. Non-Operated (n=140) Patients (Placebo and Sygen 100mg)

Operated vs. Non-Operated by Treatment Group

Summary of Findings to Date

Summary of Findings to Date (cont.)

Conclusions

SygenÆ (GM-1) Principal Investigators and Centers

SygenÆ (GM-1) Principal Investigators and Centers (cont.)