Combining HDAC Inhibitors with N-Hydroxyurea for Polycythemia Vera

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Solution Overview

Problem

Current therapies for Philadelphia-negative myeloproliferative syndromes, such as N-hydroxyurea, often result in poor tolerance and unsatisfactory therapeutic responses, with high doses required to manage side effects and a risk of thrombo-embolic events and disease progression.

Innovation Solution

Combining diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphthalen-2-yl methyl]-ammonium chloride with N-hydroxyurea, preferably in the monohydrate crystal form, to enhance treatment efficacy and reduce side effects in patients refractory to or poorly responding to N-hydroxyurea monotherapy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If N-hydroxyurea is used at high doses to treat Philadelphia-negative myeloproliferative syndromes, then therapeutic response is improved, but side effects and patient tolerance worsen

Engineering Contradiction:
Improvetherapeutic responseVSAvoidside effects
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent combines N-hydroxyurea with a histone deacetylase inhibitor (such as entinostat, panobinostat, or romidepsin) to create a synergistic therapeutic effect. This combination allows for reduced dosing of N-hydroxyurea while maintaining or improving therapeutic response, thereby reducing side effects and improving patient tolerance.

Inventive Principle:
Principle #5Merging (Combining)

2Ease of operation

If N-hydroxyurea monotherapy is used to treat Philadelphia-negative myeloproliferative syndromes, then treatment simplicity is maintained, but therapeutic efficacy is insufficient for refractory patients

Engineering Contradiction:
Improvetreatment simplicityVSAvoidtherapeutic efficacy
Core Design Contradiction:
Ease of operationVSProductivity

Solution Approach 1:

The patent introduces a combination therapy approach by merging N-hydroxyurea with histone deacetylase inhibitors. This combination specifically addresses refractory cases where monotherapy fails, improving therapeutic efficacy while maintaining a relatively simple treatment protocol through the use of established drugs with a reasonable safety profile.

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If continuous N-hydroxyurea therapy is administered to prevent disease progression, then long-term disease control is achieved, but cumulative toxicity and patient quality of life worsen

Engineering Contradiction:
Improvedisease controlVSAvoidcumulative toxicity
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the therapeutic parameter by introducing histone deacetylase inhibitors with different mechanisms of action. This allows for effective disease control through synergistic action, enabling the use of lower doses of N-hydroxyurea and reducing cumulative toxicity while maintaining reliable long-term disease control.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS8217079B2Method for treating Philadelphia-negative myeloproliferative syndromes
Publication Date: 2012.07.10 ITALFARMACO SPA

AI summary

Method for treating Philadelphia-negative myeloproliferative syndromes in a patient in need of such treatment, by administering to the patient diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphthalen-2-yl-methyl]-ammonium chloride or other pharmaceutically acceptable salts and/or solvates thereof, in combination with N-hydroxyurea.