Presentation is loading. Please wait.

Presentation is loading. Please wait.

Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-1 Backup Visuals Presented.

Published byBartholomew Lee Modified over 8 years ago

Similar presentations

Presentation on theme: "Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-1 Backup Visuals Presented."— Presentation transcript:

1 Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-1 Backup Visuals Presented

2 Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-2 Study 901 - Number of Gd+ Lesions at Baseline No. of Patients Placebo Mito 12 Lesions at Baseline 0 5 10 15 20 25 30 01234 5 to 10 > 10 28 24 33333 1 0 1 0 1 0 0

3 Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-3 Study 901 - Summary of Relapse Data p value p value Mito 12 Mito 12 PlaceboMito 5Mito 12 vs Placebo PlaceboMito 5Mito 12 vs Placebo No. relapses11370390.0009 No. treated relapses6642180.0002 No. severe relapses6036170.0008 No. relapses seen by 6344210.0026 treating physician No. relapses (adj.) 129.477.448.20.0002 No. treated relapses (adj.) 76.846.924.1 0.0002

4 Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-4 Study 901 - Definition of Severe Relapse New symptoms lasting  48 hours with functional status score  2 points 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. 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. Relapses reported by other physicians and rated as “severe” also considered severe.

5 Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-5 Study 901 - Effect of Prior Relapses on Primary Efficacy Endpoints Relapse Prior YearNo Relapse PlaceboMito 5Mito 12 PlaceboMito 5Mito 12 (n=46)(n=49)(n=45) (n=18)(n=15)(n=15) (n=46)(n=49)(n=45) (n=18)(n=15)(n=15) Mean  from baseline EDSS0.05-0.24-0.220.67-0.170.13 AI0.610.430.201.170.330.60 AI0.610.430.201.170.330.60 SNS-0.74-1.20-1.784.612.331.07 SNS-0.74-1.20-1.784.612.331.07 No. treated relapses (adjusted)58.838.120.318.08.83.7 Median time to 1st treated relapse (mo.)7.013.0NR*15.0NRNR * p<0.05 Placebo vs Mito 12 * *

6 Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-6 Study 901 - Concomitant MS Medications Used by  5 Patients at Baseline Treatment Group Class of DrugPlaceboMito 5Mito 12 Myorelaxants20107 Vitamins1075 Urologic Antispasmodics462 Minerals322

7 Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-7 Study 902 - Gd-Enhancing Scans at Month 6 by 1.0 Point EDSS Deterioration mP Mito + mP ScanScan EDSS deteriorationNegPosNegPos No411173 Yes0610

8 Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-8 Study 902 - Correlation Between Gd+ Lesion and EDSS Score Mean correlation = 0.21 (p  0.05) Mean correlation = 0.21 (p  0.05) Mean of all patients in both groups Mean of all patients in both groups –For each patient, correlation over time of total no. of Gd+ lesions with EDSS score

9 Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-9 Study 902 - Corticosteroid Use for Relapses TreatmentPatientsCourses mP1121 Mito + mP 67 Mito + mP 67

10 Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-10 Study 901 - Disability Change Month 24 to 36 0 1 2 3 EDSSAISNS Change Category Mean Change Mito 12 (n=36) Mito 5 (n=47) Placebo (n=40)

11 Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-11 Study 902 - New Lesions on T2 Weighted Scans by Lesion Size mPMito + mP Lesion size(n=20)(n=20)p-value SmallMean ± SD1.7 ± 2.8 0.6 ± 1.1NS Median (range)1 (0-11)0 (0-4) ModerateMean ± SD 2.3 ± 4.00.5 ± 0.80.036 Median (range)1 (0-17)0 (0-3) LargeMean ± SD1.6 ± 3.2 0.1 ± 0.20.001 Median (range)0.5 (0-14)0 (0-1) AllMean ± SD 5.5 ± 9.01.1 ± 1.40.024 Median (range)3 (0-38)1 (0-5)

12 Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-12 Study 903 - Infections Number of Number (%) infections of patients infections of patients Infection (n=343 infections)(n=454) Urinary tract295151 (33%) Upper respiratory tract77 (2%) Polysinusitis11 (<1%) Unknown4026 (6%)

13 Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-13 Study 901 - Infection and Hemorrhage PlaceboMito 5Mito 12 Event(n=64)(n=65)(n=62) n % n % n % Infections436755855081 Severe infections232312 Hospitalization1 a 23 b 54 c 7 Hemorrhage61058610 Hospitalization00001 d 2 a = tonsillitis b = enteritis, UTI, viral infection c = tonsillitis, UTI (2), endometritis d = hemorrhagic cystitis

14 Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-14 Study 901 - Chemistry Toxicity WHO Grade 3-4 % Patients PlaceboMito 5Mito 12 (n=64)(n=65)(n=62) (n=64)(n=65)(n=62) SGOT3.11.61.6 T. Bilirubin1.600 Alk Phosph.1.61.61.6 Creatinine000

15 Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-15 Study 901: Month 36 Menstruation Data % Patients PlaceboMito 5Mito 12 Parameter(n=24)(n=32)(n=21) Regular menses544129 Irregular menses131619 No menses8929 No data available17165 Other51818

16 Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-16 Study 901 - Hospitalizations for Reasons Other Than Study Drug Administration PlaceboMito 5Mito 12 (n=64)(n=64)(n=60) No. of patients hospitalized433624 All hospitalizations No. of hospitalizations 898550 Mean days per hospitalization31.949.035.2 MS-related hospitalizations No. of hospitalizations 816434 Mean days per hospitalization 15.025.416.2

Download ppt "Novantrone A_Backup_StudyDesignVersion 4.4 - 3/10/2016 A-1 Backup Visuals Presented."

Similar presentations

Study Design 121 Relapsing-remitting MS patients randomized to –Stress Management Therapy MS active treatment* 16 individual sessions conducted over 24.

Study Design 121 Relapsing-remitting MS patients randomized to –Stress Management Therapy MS active treatment* 16 individual sessions conducted over 24.
Tysabri ® (natalizumab) Biogen Idec Inc. BLA 125104 /15 Peripheral and Central Nervous System Drugs Advisory Committee Gaithersburg, Maryland March 7-8,

Tysabri ® (natalizumab) Biogen Idec Inc. BLA /15 Peripheral and Central Nervous System Drugs Advisory Committee Gaithersburg, Maryland March 7-8,
Long-term Safety and Effectiveness of Natalizumab STRATA MS Study.

Long-term Safety and Effectiveness of Natalizumab STRATA MS Study.
OnabotulinumtoxinA for Urinary Incontinence from Neurogenic Detrusor Overactivity.

OnabotulinumtoxinA for Urinary Incontinence from Neurogenic Detrusor Overactivity.
DWMRI ADC Patient – Rhodes Four Exams. Rhodes 10 Contours 2 Lesions Exclusion Contour – Brain Stem.

DWMRI ADC Patient – Rhodes Four Exams. Rhodes 10 Contours 2 Lesions Exclusion Contour – Brain Stem.
FREEDOMS II TRIAL.

FREEDOMS II TRIAL.
Emerging Therapies for Multiple Sclerosis

Emerging Therapies for Multiple Sclerosis
MS Register Germany International MS Conference Berlin 23.9.2003.

MS Register Germany International MS Conference Berlin
Rapivab™ - peramivir injection

Rapivab™ - peramivir injection
Memantine in Clinical Practice – Results of an Observational Study Calabrese P., Essner U. and Förstl H. Dementia and Geriatric Cognitive Disorders 2007;

Memantine in Clinical Practice – Results of an Observational Study Calabrese P., Essner U. and Förstl H. Dementia and Geriatric Cognitive Disorders 2007;
Novantrone Main Presentation Version 7.0 - 10/3/2015 M-1 Mitoxantrone for Multiple Sclerosis (Novantrone ® ) Mitoxantrone for Multiple Sclerosis (Novantrone.

Novantrone Main Presentation Version /3/2015 M-1 Mitoxantrone for Multiple Sclerosis (Novantrone ® ) Mitoxantrone for Multiple Sclerosis (Novantrone.
Pulmonary and Allergy Drugs Advisory Committee January 17, 2002 Pulmonary and Allergy Drugs Advisory Committee Meeting Gaithersburg, Maryland January 17,

Pulmonary and Allergy Drugs Advisory Committee January 17, 2002 Pulmonary and Allergy Drugs Advisory Committee Meeting Gaithersburg, Maryland January 17,
Design: A randomized, prospective, double-blind cohort followed for 16 weeks RenehaVis Original Study 50 DMW 50 HMW 50 LMW 50 Placebo.

Design: A randomized, prospective, double-blind cohort followed for 16 weeks RenehaVis Original Study 50 DMW 50 HMW 50 LMW 50 Placebo.
Prehospital Fibrinolysis with Double Antiplatelet Therapy in Acute ST-Elevation Myocardial Infarction: The Clarity Ambulance Substudy Prehospital Fibrinolysis.

Prehospital Fibrinolysis with Double Antiplatelet Therapy in Acute ST-Elevation Myocardial Infarction: The Clarity Ambulance Substudy Prehospital Fibrinolysis.
Int J MS Care 7:148-151, 2005/2006. Jan 9 & 10, 2007 1 Clinical Stabilization of a MS Patient after Tonsillectomy presented by Michael C. Levin, MD Department.

Int J MS Care 7: , 2005/2006. Jan 9 & 10, Clinical Stabilization of a MS Patient after Tonsillectomy presented by Michael C. Levin, MD Department.
No prior therapy with PI

No prior therapy with PI
CURRY  Design Open-label CURRY Study: SOF + RBV for HCV with liver cancer before transplantation ≥ 18 years Chronic HCV infection Any genotype HCV RNA.

CURRY  Design Open-label CURRY Study: SOF + RBV for HCV with liver cancer before transplantation ≥ 18 years Chronic HCV infection Any genotype HCV RNA.
Efficacy and Safety of Maraviroc in Treatment- Experienced (TE) Patients Infected with R5 HIV-1: 96-week Combined Analysis of the MOTIVATE 1 & 2 Studies.

Efficacy and Safety of Maraviroc in Treatment- Experienced (TE) Patients Infected with R5 HIV-1: 96-week Combined Analysis of the MOTIVATE 1 & 2 Studies.
CE-1 IRESSA ® Clinical Efficacy Ronald B. Natale, MD Director Cedars Sinai Comprehensive Cancer Center Ronald B. Natale, MD Director Cedars Sinai Comprehensive.

CE-1 IRESSA ® Clinical Efficacy Ronald B. Natale, MD Director Cedars Sinai Comprehensive Cancer Center Ronald B. Natale, MD Director Cedars Sinai Comprehensive.
Pulmonary-Allergy Drugs Advisory Committee May 1, 2007 FDA Presentation Advair Diskus 500/50 Carol Bosken, MD, ScM, MPH Medical Officer Division of Pulmonary.

Pulmonary-Allergy Drugs Advisory Committee May 1, 2007 FDA Presentation Advair Diskus 500/50 Carol Bosken, MD, ScM, MPH Medical Officer Division of Pulmonary.

Similar presentations

Ads by Google