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Methods for treating progressive multiple sclerosis

a progressive multiple sclerosis and treatment method technology, applied in the field of progressive multiple sclerosis treatment, can solve the problems of reducing known beneficial treatments, and the treatment approach based on this theory, and not fully preventing the occurrence of exacerbation or accumulation of disability

Inactive Publication Date: 2012-09-06
GENENTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides methods of treating progressive multiple sclerosis in a patient by administering an anti-CD20 antibody. The treatment is based on the patient's age, the presence of gadolinium staining lesions, the increase in EDSS over two years prior to treatment, and the MSSS. The treatment can reduce the time to confirmed disease progression and can be effective even if the patient is not diagnosed with relapsing remitting multiple sclerosis when starting treatment. The anti-CD20 antibody used in the treatment can be ocrelizumab, rituximab, ofatumumab, or other anti-CD20 antibodies. Evidence of inflammation in a sample, such as a cerebrospinal fluid sample, can also be used to determine if the patient is suitable for treatment.

Problems solved by technology

MS is a major cause of neurologic disability in young and middle-aged adults and, until the past decade, has had no known beneficial treatments.
Therapeutic approaches based on this theory such as IFN-beta and glatiramer acetate decrease, but do not fully prevent, occurrence of exacerbations or accumulation of disability.

Method used

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  • Methods for treating progressive multiple sclerosis
  • Methods for treating progressive multiple sclerosis
  • Methods for treating progressive multiple sclerosis

Examples

Experimental program
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Effect test

example 2

A Phase II / III Study of Rituximab in Primary Progressive Multiple Sclerosis (PPMS)

[0400]A randomized, double-blind, parallel group, placebo controlled, multicenter Phase II / III study (U2786g) to evaluate the safety and efficacy of rituximab in adults with Primary Progressive Multiple Sclerosis (PPMS) as defined by McDonald et al (Ann Neurol 50:121-7 (2001)) was performed.

[0401]Subjects were randomized in a 2:1 ratio to receive either rituximab or placebo. Rituximab, commercially available from Genentech, was formulated for i.v. administration as a sterile product in 9.0 mg / ml sodium chloride, 0.7 mg / ml polysorbate 80, 7.35 mg / ml sodium citrate dehydrate, and sterile water for injection (pH 6.5). Each course of study drug consisted of two i.v. infusions (separated by 14 days) of 1000 mg rituximab or placebo. Subjects received the first course of treatment at Days 1 and 15 and received additional courses at Weeks 24, 48, and 72. Subjects received acetaminophen (1 g) and diphenhydramin...

example 3

A Phase III Study of Ocrelizumab in Progressive Multiple Sclerosis

[0415]A Phase III, randomized, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of 600 mg of ocrelizumab as compared with placebo in adults with progressive MS is performed.

[0416]A total of 630 progressive MS patients (315 with progressive onset and 315 with relapsing onset MS) are enrolled and assigned (2:1 randomization) to either ocrelizumab arm or placebo arm stratified by site and type of multiple sclerosis. This study consists of the following three periods that apply to all patients: a screening period, a treatment period and a treatment free follow up period. In the first course of study drug treatment (300 mg ocrelizumab or placebo infusion×2) are administered on Days 1 and 15. In subsequent treatment courses, patients are dosed (600 mg ocrelizumab single infusion) every 24 weeks until the last patient enrolled receives his / her last course of treatment to be administered at ...

example 4

A Phase III Study of Ocrelizumab in Primary Progressive Multiple Sclerosis

[0435]A Phase III, randomized, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of one of two dose regimens of ocrelizumab as compared with placebo in adults with primary progressive MS is performed.

[0436]The two ocrelizumab dose regimens under investigation are as follows: 1) ocrelizumab 1000 mg dose regimen: consisting of a dual infusion of 1000 mg for the first treatment cycle followed by single infusions of 1000 mg for the subsequent treatment cycles and 2) ocrelizumab 600 mg dose regimen: consisting of a dual infusion of 300 mg for the first treatment cycle followed by single infusions of 600 mg for the subsequent treatment cycles.

[0437]A total of 630 primary progressive MS patients are enrolled and assigned (2:1 randomization) to either ocrelizumab arm or placebo arm stratified by site and type of multiple sclerosis. This study consists of the following three periods th...

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Abstract

The present invention concerns methods for treating progressive multiple sclerosis (MS) in a patient, and an article of manufacture with instructions for such use.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a Divisional of U.S. patent application Ser. No. 12 / 561,131, filed Sep. 16, 2009, which claims priority benefit to U.S. Provisional Application Ser. No. 61 / 097,464, filed Sep. 16, 2008, all of which are hereby incorporated by reference in their entirety.[0002]SUBMISSION OF SEQUENCE LISTING AS ASCII TEXT FILE[0003]The content of the following submission on ASCII text file is incorporated herein by reference in its entirety: a computer readable form (CRF) of the Sequence Listing (file name: 146392006110SeqList.txt, date recorded: Mar. 7, 2012, size: 33 KB).FIELD OF THE INVENTION[0004]The present invention concerns methods for treating progressive multiple sclerosis (MS) in a patient, and an article of manufacture with instructions for such use.BACKGROUND OF THE INVENTIONMultiple Sclerosis[0005]Multiple Sclerosis (MS) is an inflammatory and demyelinating degenerative disease of the human central nervous system (CNS). It i...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K39/395A61P25/00
CPCA61K39/00A61K2039/505A61K2039/545G06Q99/00C07K16/2887C07K2317/24C07K2317/76A61K2039/55A61B5/055A61K9/0019A61K39/3955A61K45/06A61K2039/507C07K2317/565G01N33/686G01N2800/52G01N2800/7095A61P25/00A61P25/28A61P29/00A61P37/00A61P37/02A61P37/06
Inventor SMITH, CRAIGCHIN, PETER S.
Owner GENENTECH INC
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