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Treatment of bone disorders

A disease, bone loss technology, applied in the field of antagonists, can solve the unknown problems of efficacy, long-term tolerability and toxicity

Inactive Publication Date: 2008-04-23
GENENTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although bisphosphonates are considered a potential therapy for slowing structural changes in rheumatoid arthritis, efficacy, long-term tolerability, and toxicity are unknown and more trials are needed

Method used

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  • Treatment of bone disorders
  • Treatment of bone disorders
  • Treatment of bone disorders

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0392] Example 1: Serum biochemical markers are associated with response to rituximab treatment in rheumatoid arthritis Background:

[0393] It has been found that using rituximab (RTX; ) targeting B cells provides a new approach for the treatment of rheumatoid arthritis (RA). A randomized controlled trial in patients with active rheumatoid arthritis despite methotrexate showed that a single course of two rituximab infusions, alone or in combination with cyclophosphamide or continued methotrexate Amhotrexate at week 24 (Edwards et al., N.Engl.J.Med. (2004), supra; Pavelka et al., supra) and week 48 (Edwards et al., N.Eng.J Med. (2004), supra) all provided significant improvements in disease activity, which persisted for two years in some patients (Emery et al., (2004), supra). However, little is known about its mechanism of action in treating RA or its effects on various biomarkers in RA patients. Specifically, it is not known whether B-cell depleting therapies, such as ri...

Embodiment 2

[0423] Example 2: Bone Remodeling in Animals

[0424] The activity of rituximab can be demonstrated in animal models of bone remodeling. In this way, the Sprague-Dawley rats were matched according to body weight and divided into 7 groups with 10 animals in each group. Includes a baseline control group in which rats were sacrificed at the beginning of the study; a vehicle-only control group; a PBS-treated control group; and a positive control group administered a compound known to promote bone growth. The remaining three groups were administered rituximab at three dose levels.

[0425] Rituximab, positive control compound, PBS, or vehicle alone were administered subcutaneously once daily for 35 days. All animals were injected with calcein 9 and 2 days before sacrifice (two calcein injections on each indicated day). Body weights were determined weekly. At the end of the 35-day cycle, animals were weighed and bled by orbital or cardiac puncture. Serum calcium, phosphate, ost...

Embodiment 3

[0427] Embodiment 3: Clinical research of rituximab in osteoporosis

[0428] Patients diagnosed with osteoporosis can be treated with rituximab. Treated patients will be selected not to suffer from B-cell malignancies.

[0429] The patient is administered rituximab intravenously (IV) according to any of the following dosage regimens:

[0430] (A) 50mg / m 2 IV Day 1; 150mg / m 2 IV Days 8, 15 and 22

[0431] (B) 150mg / m 2 IV Day 1; 375mg / m 2 IV Days 8, 15 and 22

[0432] (C)375mg / m 2 IV on days 1, 8, 15 and 22

[0433] (D) 1 g IV on days 1 and 15

[0434] The rituximab therapy may be combined with other adjuvant therapies, such as agents for osteoclast-related disorders, as described above, but it is preferred to treat the patient with rituximab as a single agent throughout the course of treatment. Another group of patients was administered a control with placebo (rituximab formulation solution without rituximab).

[0435] Overall response rates were determined based on...

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Abstract

Methods of treatment of various bone indications, such as osteoporosis, in a mammal are provided wherein an effective amount of an antagonist that binds to a B-cell surface marker, such as a CD20 antibody, is administered, optionally also with another medicament such as an agent that treats such disorders in an effective amount. Articles of manufacture are also provided. Further, a method of inhibiting osteolysis in a mammal is provided comprising introducing into said mammal an isolated odontoprogenitor or osteoprogenitor cell comprising a nucleic acid encoding an antibody that binds to a B-cell surface marker.

Description

[0001] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 60 / 656,943, filed February 28, 2005, which application is hereby incorporated in its entirety. field of invention [0002] The present invention relates to the treatment of bone disorders with antagonists that bind B cell surface markers such as CD20 or CD22, eg antibodies that bind CD20. Background of the invention [0003] bone disease [0004] Bone remodeling is a dynamic process that maintains tissue mass and bone architecture. This process is a balance between bone resorption and bone formation, and two cell types, osteoclasts and osteoblasts, are thought to play a major role. Osteoblasts synthesize new bone and deposit it into the holes dug by osteoclasts. The activity of osteoblasts and osteoclasts is regulated by many systemic and local factors, including growth factors. [0005] Bone is a specialized dynamic connective tissue that performs the following func...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/28A61K39/395A61K35/32
CPCA61K47/48561A61K31/59A61K35/32A61K31/66A61K38/2026A61K39/39541A61K31/716A61K2039/505C07K16/2887C07K2316/96C07K2317/24A61K45/06A61K38/19A61K47/6849A61P1/02A61P19/00A61P19/02A61P19/08A61P19/10A61P35/00A61P43/00A61K2300/00A61K39/395
Inventor K·L·休厄尔乔安妮·匡
Owner GENENTECH INC
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