Methotrexate Simvastatin Combination for Osteosarcoma Treatment

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Solution Overview

Problem

High doses of methotrexate used in osteosarcoma treatment often result in severe adverse side effects, including myelosuppression, mucositis, and neurotoxicity, which can lead to premature interruption of chemotherapy and long-term neurological damage, particularly in children.

Innovation Solution

Combining methotrexate with simvastatin produces a synergistic effect, allowing for reduced methotrexate doses while maintaining treatment efficacy, thereby minimizing side effects and preventing recurrence in osteosarcoma patients.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If high doses of methotrexate are administered to treat osteosarcoma, then treatment efficacy is improved, but severe adverse side effects occur

Engineering Contradiction:
Improvetreatment efficacyVSAvoidadverse side effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the dosage parameter of methotrexate from high doses to reduced doses, and introduces a new parameter (simvastatin) to maintain treatment efficacy at lower methotrexate levels. This resolves the contradiction by finding optimal dosage parameters that balance efficacy and toxicity

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates a composite chemotherapy regimen combining methotrexate with simvastatin. This composite approach allows the two drugs to work synergistically, maintaining anti-tumor efficacy while reducing the toxic burden compared to high-dose methotrexate alone

Inventive Principle:
Principle #40Composite materials

2Productivity

If high doses of methotrexate are used, then anti-tumour effect is strengthened, but neurotoxicity and other severe side effects increase

Engineering Contradiction:
Improveanti-tumour effectVSAvoidneurotoxicity
Core Design Contradiction:
ProductivityVSObject-generated harmful factors

Solution Approach 1:

The patent modifies the dosage parameters by reducing methotrexate to 1-3 g/m² (from typical high doses of 3-12 g/m²) and adding simvastatin at 20-80 mg/m². This parameter optimization maintains anti-tumor productivity while minimizing neurotoxicity and other severe side effects

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

Simvastatin acts as an intermediary agent that enhances the anti-tumor effect of methotrexate, allowing lower methotrexate doses to achieve the same therapeutic effect. This intermediary role of simvastatin reduces the direct toxic burden on neurological systems

Inventive Principle:
Principle #24Intermediary (Mediator)

3Object-affected harmful factors

If methotrexate dose is reduced, then side effects decrease, but treatment efficacy may be compromised

Engineering Contradiction:
Improveside effectsVSAvoidtreatment efficacy
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent merges methotrexate with simvastatin in a combination regimen. This combination allows the reduced-dose methotrexate to maintain efficacy through synergistic interaction with simvastatin, preventing the compromise of treatment reliability that would normally occur with dose reduction

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent optimizes the dosage parameters of both drugs: methotrexate at 1-3 g/m² and simvastatin at 20-80 mg/m². This parameter optimization ensures that side effects are reduced while treatment efficacy is maintained or improved through the synergistic combination

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP3028704B1Combinations of methotrexate and simvastatin for use in the treatment of osteosarcoma
Publication Date: 2021.03.31 DALANA3
  • EP3028704B1 patent drawingFigure 1A~1B
  • EP3028704B1 patent drawingFigure 2
  • EP3028704B1 patent drawingFigure 3A~3B

AI summary

The invention relates to the use of an inhibitor of the dihydrofolate reductase enzyme selected from the group that consists of methotrexate, trimetrexate and pemetrexed; or a pharmaceutically acceptable salt thereof, for the preparation of a drug for the treatment or prevention of recurrences of a disease selected from the group that consists of cancer, psoriasis, psoriatic arthritis, juvenile polyarticular arthritis, rheumatoid arthritis, Crohn's disease, polymyositis, dermatomyositis and sarcoidosis, wherein said treatment or prevention includes administering to a patient, simultaneously, separately or sequentially, a lipophilic statin and the inhibitor of the dihydrofolate reductase enzyme. The invention also relates to a pharmaceutical composition which includes the inhibitor of the dihydrofolate reductase enzyme and the lipophilic statin together with pharmaceutically acceptable carriers and/or vehicles.