Introduction

2/6/03


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Table of Contents

PPT Slide

Introduction

MPS I

MPS I: Clinical Background

Clinical Studies

BIO7500

BIO 7500 Notable evaluations

BIO7500 Results

BIO7500 Safety Results

BIO7500 Safety Results (Cont.)

BIO7500 Conclusion

Study 003

Study 003 Notable evaluations

Study 003 Endpoints

Study 003 Endpoints

Study 003 Results

Study 003 Results

Study 003 Results Baseline Characteristics (Cont.)

Study 003 Results % FVC

Study 003: % FVC by study visit

Study 003 FVC

Study 003: % FVC by gender and study visit (baseline height)

Study 003 Results % FVC by age category

Study 003 Impairment % FVC at baseline

Study 003 Results % FVC by impairment versus gender

Study 003 6 Minute Walk Distance

Study 003 6 MWD

Study 003: 6 MWD by gender & study visit

Study 003 6 MWD by impairment at baseline

Study 003 6 MWD by age category

Study 003 2nd EP: Apnea Hypopnea Index Change in AHI from baseline to week 26

Study 003 Secondary endpoints (Cont.)

Study 003 Tertiary Endpoints

Study 003 Pharmacokinetic studies

Study 003 Safety

Study 003 Safety (Cont.)

Study 003 Conclusions

Study 003 Conclusions (Cont.)

Study 006

Study 006 % FVC by study visit

Study 006 Changes FVC by Gender Study 003 or 006

Study 006 Changes FVC by Age in Study 003 or 006

Study 006 % FVC changes

Study 006 6MWD

Study 006 Results 6MWD in subset analyses

2nd EP: AHI Changes in Studies 003 and 006

Study 006: Other Endpoints

Study 006 Safety

Study 006 Safety

Study 006 Conclusions

Overall Conclusions: Efficacy

Overall Conclusions Safety

 Author: MKW