# Presentation: 110899

## Backup Visuals Presented

## Study 901 - Number of Gd+ Lesionsat Baseline

**No. of Patients **

**Placebo**

**Mito 12**

**Lesions at Baseline**

**0**

**5**

**10**

**15**

**20**

**25**

**30**

**0**

**1**

**2**

**3**

**4**

**5 to 10**

**> 10**

**28**

**24**

**3**

**3**

**3**

**3**

**3**

**1**

**0**

**1**

**0**

**1**

**0**

**0**

## 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**

## 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.**

## 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**
** ****	****	****(n=46)****	****(n=49)****	****(n=45) ****	****(n=18)****	****(n=15)****	****(n=15)**
**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**

*** p<0.05 Placebo vs Mito 12**

*****

*****

## 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**
**Urologic Antispasmodics****	****4****	****6****	****2**
**Minerals****	****3****	****2****	****2**

## Study 902 - Gd-Enhancing Scans at Month 6by 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**

## Study 902 - Correlation BetweenGd+ 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**

## Study 902 - Corticosteroid Use for Relapses

**	****Treatment****	****Patients****	****Courses****	****	**
**	****mP****	****11****	****21****	**
**	**** ****Mito + mP ****	****6****	****7**

## Study 901 - Disability Change  Month 24 to 36

**0**

**1**

**2**

**3**

**EDSS**

**AI**

**SNS**

**Change Category**

**Mean Change**

**Mito 12  (n=36)**

**Mito 5  (n=47)**

**Placebo  (n=40)**

## Study 902 - New Lesions on T2 WeightedScans by Lesion Size

**	****	****	****mP****	****Mito + mP**
**Lesion size****	****	****(n=20)****	****(n=20)****	****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)**

## Study 903 - Infections

**	****Number of****	**** Number (%)**
**	**** ****infections****	**** of patients**
**Infection ****	****(n=343 infections)****	****(n=454)**
**Urinary tract****	****295****	****151 (33%)**
**Upper respiratory tract****	****7****	****7 (2%)**
**Polysinusitis****	****1****	****1 (<1%)**
**Unknown****	****40****	****26 (6%)**

## Study 901 - Infection and Hemorrhage

**	****	****Placebo****	****Mito 5****	****Mito 12**
**	****Event****	****(n=64)****	****(n=65)****	****(n=62)**
**	****	****n       %****	**** n       %****	**** n       %**

**Infections****	****43****	****67****	****55****	****85****	****50****	****81**
**	****	****Severe infections****	****2****	****3****	****2****	****3****	****1****	****2****	****Hospitalization****	****1****a****	****2****	****3****b****	****5****	****4****c****	****7**
**Hemorrhage****	****6****	****10****	****5****	****8****	****6****	****10**
**	****	****Hospitalization****	****0****	****0****	****0****	****0****	****1****d****	****2**

**a = tonsillitis**
**b = enteritis, UTI, viral infection**
**c = tonsillitis, UTI (2), endometritis**
**d = hemorrhagic cystitis**

## Study 901 - Chemistry Toxicity WHO Grade 3-4

**	****	****% Patients**
**	****Placebo****	****Mito 5****	****Mito 12**
**  ****	****(n=64)****	****(n=65)****	****(n=62)**
**SGOT****	****3.1****	****1.6****	****1.6**
**T. Bilirubin****	****1.6****	****0****	****0**
**Alk Phosph.****	****1.6****	****1.6****	****1.6**
**Creatinine****	****0****	****0****	****0**

## Study 901: Month 36 Menstruation Data

**	****	****	****% Patients**
**	****	****Placebo****	****Mito 5****	****Mito 12**
**Parameter****	****(n=24)****	****(n=32)****	****(n=21)**

**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**

## Study 901 - Hospitalizations for Reasons Other Than Study Drug Administration

**	****	****Placebo****	****Mito 5****	****Mito 12**
**	****	****(n=64)****	****(n=64)****	****(n=60)**
**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**