Backup Visuals Presented

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Backup Visuals Presented
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Study 901 - Number of Gd Lesionsat Baseline
30
28
Placebo
Mito 12
24
25
20
No. of Patients
15
10
5
3
3
3
3
3
1
1
1
0
0
0
0
0
0
1
2
3
4
5 to 10
gt 10
Lesions at Baseline
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Study 901 - Summary of Relapse Data
p value Mito 12 Placebo Mito 5 Mito
12 vs Placebo No. relapses 113 70 39 0.0009 No
. treated relapses 66 42 18 0.0002 No. severe
relapses 60 36 17 0.0008 No. relapses seen by
63 44 21 0.0026 treating physician No.
relapses (adj.) 129.4 77.4 48.2 0.0002 No.
treated relapses (adj.) 76.8 46.9 24.1 0.0002
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Study 901 - Definition of Severe Relapse

• New symptoms lasting ? 48 hours with functional
  status score ? 2 points
• Or deterioration of existing symptoms ? 1 point
  in at least one of the four following systems
  pyramidal, brain stem, cerebellar, or visual.
• Relapses reported by other physicians and rated
  as severe also considered severe.

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Study 901 - Effect of Prior Relapses on Primary
Efficacy Endpoints
Relapse Prior Year No Relapse Placebo Mito
5 Mito 12 Placebo Mito 5 Mito 12
(n46) (n49) (n45) (n18) (n15) (n15) Mean
? from baseline EDSS 0.05 -0.24 -0.22 0.67 -0
.17 0.13 AI 0.61 0.43 0.20 1.17 0.33 0.60
SNS -0.74 -1.20 -1.78 4.61 2.33 1.07 No. treated
relapses (adjusted) 58.8 38.1 20.3 18.0 8.8 3.7
Median time to 1st treated relapse
(mo.) 7.0 13.0 NR 15.0 NR NR


plt0.05 Placebo vs Mito 12
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Study 901 - Concomitant MS Medications Used by ?
5 Patients at Baseline
Treatment Group Class of Drug Placebo Mito
5 Mito 12 Myorelaxants 20 10 7 Vitamins 10 7 5 Uro
logic Antispasmodics 4 6 2 Minerals 3 2 2
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Study 902 - Gd-Enhancing Scans at Month 6by 1.0
Point EDSS Deterioration
mP Mito mP Scan Scan
EDSS deterioration Neg Pos Neg Pos No 4 11 17 3
Yes 0 6 1 0
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Study 902 - Correlation BetweenGd Lesion and
EDSS Score

• Mean correlation 0.21 (p?0.05)
• Mean of all patients in both groups
• For each patient, correlation over time of total
  no. of Gd lesions with EDSS score

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Study 902 - Corticosteroid Use for Relapses
Treatment Patients Courses mP 11 21 Mito
mP 6 7
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Study 901 - Disability Change Month 24 to 36
Mito 12 (n36)
3
Mito 5 (n47)
Placebo (n40)
2
Mean Change
1
0
EDSS
AI
SNS
Change Category
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Study 902 - New Lesions on T2 WeightedScans by
Lesion Size
mP Mito mP Lesion size (n20) (n20) p-value
Small Mean SD 1.7 2.8 0.6 1.1 NS Median
(range) 1 (0-11) 0 (0-4) Moderate Mean SD 2.3
4.0 0.5 0.8 0.036 Median (range) 1 (0-17) 0
(0-3) Large Mean SD 1.6 3.2 0.1
0.2 0.001 Median (range) 0.5 (0-14) 0
(0-1) All Mean SD 5.5 9.0 1.1
1.4 0.024 Median (range) 3 (0-38) 1 (0-5)
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Study 903 - Infections
Number of Number () infections of
patients Infection (n343 infections) (n454) Uri
nary tract 295 151 (33) Upper respiratory
tract 7 7 (2) Polysinusitis 1 1
(lt1) Unknown 40 26 (6)
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Study 901 - Infection and Hemorrhage
Placebo Mito 5 Mito 12 Event (n64) (n65) (n6
2) n n n
Infections 43 67 55 85 50 81 Severe
infections 2 3 2 3 1 2 Hospitalization 1a 2 3b 5
4c 7 Hemorrhage 6 10 5 8 6 10 Hospitalization 0
0 0 0 1d 2
a tonsillitis b enteritis, UTI, viral
infection c tonsillitis, UTI (2),
endometritis d hemorrhagic cystitis
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Study 901 - Chemistry Toxicity WHO Grade 3-4
Patients Placebo Mito 5 Mito 12
(n64) (n65) (n62) SGOT 3.1 1.6 1.6 T.
Bilirubin 1.6 0 0 Alk Phosph. 1.6 1.6 1.6 Creatini
ne 0 0 0
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Study 901 Month 36 Menstruation Data
Patients Placebo Mito 5 Mito
12 Parameter (n24) (n32) (n21)
Regular menses 54 41 29 Irregular
menses 13 16 19 No menses 8 9 29 No data
available 17 16 5 Other 5 18 18
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Study 901 - Hospitalizations for Reasons Other
Than Study Drug Administration
Placebo Mito 5 Mito 12 (n64) (n64) (n60) No
. of patients hospitalized 43 36 24 All
hospitalizations No. of hospitalizations
89 85 50 Mean days per hospitalization 31.9 49.0
35.2 MS-related hospitalizations No. of
hospitalizations 81 64 34 Mean days per
hospitalization 15.0 25.4 16.2