Method of treating osteoarthritis

Inactive Publication Date: 2020-06-04
ORTHOTROPHIX INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0045]MRI commonly is used to diagnose features of osteoarthritis such as articular cartilage thinning or meniscal pathology. Bone shape before and after treatment can be analyzed using imag

Problems solved by technology

Corticosteroid injections have been implicated in further cartilage degeneration in the knees (McAlindon 2017) limiting the willingness of clinicians to use this treatment modality.
While joint pain reduction may persist for weeks to months in some patients (Cohen 1998), multiple clinical trials have failed to demonstrate a clinically meaningful treatment effect.
Unfortunately, articular cartilage does not regenerate naturally, neither after trauma nor in the setting of chronic “wear and tear” of aging (Buckwalter 2002).
However, fibrocartilage has much less structural strength and stability than normal articular cartilage and degenerates more quickly.
Treatment failures are common, as is the need for additional surgery to manage complications.
Common complications include delamination, graft failure, and disturbed graft fusion (Niemeyer 2008).
The final option for patients with disabling knee OA is joint replacement surgery, an invasive and expensive option with potential for serious morbid complications.
However, average age of the patients who receive TKR has been falling.
While numerous drugs believed to inhibit cartilage degeneration in knee OA have been tested in controlled clinical trials, thus far none has been successful in slowing or stopping cartilage loss.
However, clinical observations have led some researchers to question whether cartilage degeneration may follow changes in other parts of the joint.
On the other hand, many OA pa

Method used

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  • Method of treating osteoarthritis
  • Method of treating osteoarthritis
  • Method of treating osteoarthritis

Examples

Experimental program
Comparison scheme
Effect test

Example

Example 1

A Randomized Double-Blind Placebo Control Study of TPX-100 in the Patients with Osteoarthritis of the Knees

[0129]Clinical Study Methodology

[0130]Outline of the Study

[0131]A multicenter, randomized double-blind, placebo-controlled study was designed to investigate the safety, tolerability, pharmacokinetics, and efficacy of TPX-100 administered in four weekly doses in subjects with bilateral patello-femoral knee osteoarthritis. The study was conducted under an open IND (investigational new drug application) at CDER (Center for Drug Evaluation and Research) of the U.S. FDA (The United States Food and Drug Administration) in compliance with GCP (Good Clinical Practice) and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidelines. Eighteen (18) orthopedic, rheumatologic and family practice centers in the U.S. participated in the study.

[0132]The study was divided into Part A and Part B. The Part A was d...

Example

Example 2

A Randomized Double-Blind Placebo Control Study of TPX-100 in the Patients with Osteoarthritis of the Knees—Data Analysis with Stricter Qualification Standard Applied to the MRI Image Quality

[0225]Objectives

[0226]After the data analyses in EXAMPLE 1, a few more MRI images were questioned with regard to their technical quality to enable assessment of periarticular bone shape change over time. In order to assure the quality of the overall analysis results, a stricter qualification standard was applied to the MRI images used in EXAMPLE 1, and requalification was performed. Seventy-nine (79) subjects were requalified. The MRI knee images of these subjects were re-analyzed for their periarticular bone shape changes, as well as their correlations with the changes of tibiofemoral cartilage thickness and pain, respectively, in the same manner as described in EXAMPLE 1.

Results

[0227]The requalified 79 subjects were included in the efficacy analysis per the Statistical Analysis Plan.

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Abstract

A method of treating osteoarthritis by modifying the shape change of bone(s) underlying articular cartilage, comprising evaluating the bone shape of the patient's joint, injecting the patient with a peptide of SEQ ID No. 1 or applying other therapeutic interventions that can reduce the shape change of the bone(s) underlying articular cartilage, and thereafter evaluating the bone shape of the patient's joint is disclosed.

Description

FIELD OF THE INVENTION[0001]The invention relates generally to methods of treating osteoarthritis by modifying joint bone shape change, which is a pathology underlying onset and progression of osteoarthritis.BACKGROUNDOsteoarthritis[0002]Osteoarthritis is the most common disease of the joints, and one of the most widespread of all chronic diseases. In the US, osteoarthritis (OA) is second only to heart disease as a cause of work disability in men over 50 years of age. Globally, osteoarthritis is the 6th leading cause of years living with disability (Woolf 2003).[0003]Approximately 80% of OA patients need treatment in the knee. Within the knee joint of symptomatic individuals, the most common radiographic pattern is loss of articular (hyaline) cartilage and remodeling of adjacent bone, often with osteophyte formation at the joint margins. Both the tibiofemoral and patello-femoral compartments are commonly affected by degenerative changes. Patello-femoral arthritis due to loss of cart...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61B5/00A61K38/16
CPCA61B5/4585A61B5/4824A61K9/0019A61K38/16C07K14/47A61K38/1709A61P19/02A61B17/562A61B5/4528A61B5/055A61B2017/561A61B2017/564
Inventor KUMAGAI, YOSHINARIMCGUIRE, DAWNMILLER, MEGHANROSEN, DAVID
Owner ORTHOTROPHIX INC
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