4-Hydroxytestosterone Breast Cancer Treatment

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Solution Overview

Problem

Current therapeutic approaches for breast cancer, particularly estrogen receptor-negative (ER-negative) tumors, are ineffective due to limitations in aromatase inhibitors and hormonal treatments, with a need for alternative compounds that can target androgen receptors (AR) without aromatization, to inhibit tumor growth and metastasis.

Innovation Solution

The use of 4,17β-dihydroxyandrost-4-ene-3-one (4-hydroxytestosterone) and its esters, which specifically bind to the androgen receptor (AR) with high affinity, are not metabolized by aromatase or 5-alpha reductase, allowing for effective therapeutic and prophylactic treatment of breast cancer, including ER-negative cases, through topical administration to directly target cancer cells.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If aromatase inhibitors are used to block estrogen production, then ER-positive breast cancer growth is inhibited, but ER-negative tumors remain untreated and aromatizable androgens may be converted to estrogens promoting cancer growth

Engineering Contradiction:
Improveeffectiveness against ER-positive breast cancerVSAvoidefficacy against ER-negative breast cancer
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent changes the chemical parameter of the steroid compound by introducing a 4-hydroxy group modification to testosterone, creating 4-hydroxytestosterone. This structural modification prevents aromatization while maintaining androgen receptor binding affinity, transforming the compound's metabolic fate and biological activity profile to achieve efficacy against both ER-positive and ER-negative breast cancers

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent converts the harmful aromatization pathway (which produces estrogen that promotes cancer growth) into a beneficial outcome by designing a compound that cannot be aromatized. The blocked aromatization pathway prevents harmful estrogen production while the compound's androgenic activity promotes apoptosis in breast cancer cells, including ER-negative cells

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

2Ease of operation

If testosterone is administered to target androgen receptors, then AR-positive breast cancer cells are affected, but rapid metabolization to estradiol or DHT promotes cancer growth

Engineering Contradiction:
Improvesimplicity of androgen therapyVSAvoidcancer-promoting metabolites
Core Design Contradiction:
Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The patent extracts or removes the problematic aromatizable A-ring structure from testosterone by introducing a 4-hydroxy group that blocks aromatization. This extraction of the harmful metabolic pathway allows the compound to maintain androgenic activity without generating harmful estrogen metabolites

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The 4-hydroxytestosterone compound acts as an intermediary substance that delivers androgenic therapeutic effects without undergoing the harmful metabolic transformation to estradiol. It serves as a bridge between androgen therapy and cancer treatment, providing the desired biological effect while avoiding the harmful metabolic byproducts

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If Tamoxifen is used as an estrogen receptor antagonist, then breast cancer growth is inhibited, but tachyphylaxy and estrogen-like side effects limit long-term use

Engineering Contradiction:
Improveinhibitory effect on tumor proliferationVSAvoidduration of therapy
Core Design Contradiction:
ReliabilityVSDuration of action of moving object

Solution Approach 1:

Instead of using an estrogen receptor antagonist like Tamoxifen that blocks estrogen signaling, the patent inverts the approach by using an androgen receptor agonist (4-hydroxytestosterone) that activates AR signaling to induce apoptosis. This inverted mechanism avoids Tamoxifen's side effects and tachyphylaxy while achieving anti-proliferative effects

Inventive Principle:
Principle #13The other way round (Inversion)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

These compounds induce anabolic effects in AR-positive cells and apoptotic effects in breast cancer cells, providing a significant therapeutic advantage by effectively treating both ER-positive and ER-negative tumors, reducing tumor volume, and preventing recurrence with minimal systemic side effects.

Implementation Method 1

specifically bind to the androgen receptor (AR) with high affinity

Methodology Applied
Scientific EffectReceptor binding:

Implementation Method 2

not metabolized by aromatase or 5-alpha reductase

Methodology Applied
Scientific EffectEnzyme resistance:

Data Source

PatentEP2018170B1Medication against breast cancer
Publication Date: 2012.07.25 MABEL GMBH
  • EP2018170B1 patent drawingFigure 1A
  • EP2018170B1 patent drawingFigure 1B
  • EP2018170B1 patent drawingFigure 1C

AI summary

The present invention relates to novel uses of a steroid compound, which specifically binds to the androgen receptor (AR) but which is not metabolized by aromatase to a process for their preparation, to pharmaceutical compositions containing them, and to the use of said compounds for the prophylaxis and/or treatment of hormone-dependent or hormone receptor regulated cancers in mammals.