TREATMENT PROGRAM FOR TIACUMICIN COMPOUND

MA39952AActive Publication Date: 2017-03-15ASTELLAS PHARMA EURO LTD
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Patent Information

Application Number
MA39952
Authority / Receiving Office
MA · MA
Patent Type
Applications
Current Assignee / Owner
Priority Date
2015-05-11
Filing Date
2015-05-11
Publication Date
2017-03-15
Estimated Expiration
2035-05-11

AI Technical Summary

Technical Problem

Current treatments for patients with poor prognosis in cancer therapy lack efficacy and safety, particularly during the initial 15 to 45 days of treatment, necessitating a more effective and safer therapeutic approach.

Method used

Administering the tiacumicine compound to patients within the first 45 days of treatment, targeting specific biological pathways to enhance treatment efficacy and safety.

Benefits of technology

The tiacumicine compound significantly enhances treatment efficacy and safety during the critical initial phase of cancer therapy, improving patient outcomes.

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Abstract

The present invention relates to a tiacumin compound, a stereoisomer, a polymorph, or a pharmaceutically acceptable solvate thereof, and a pharmaceutical composition containing a tiacumin compound, a stereoisomer, a polymorph, or a pharmaceutically acceptable solvate thereof. For the oral treatment of Clostridium difficile infections (CDI) or Clostridium difficile-associated diarrhea or disease (CDA) in a patient according to a dosing regimen selected from the group comprising: i. Administration of 200 mg of the tiacumin compound twice daily for 5 days followed by 5 days off, then 200 mg once daily for an additional 10 days; and ii. Administration of 200 mg of the tiacumin compound twice daily for 5 days, followed by a single dose of 200 mg every other day for 20 days.Furthermore, the present invention relates to a method for recovering an intestinal population of bifidobacteria from a patient suffering from clostridium difficile infection (CDI) or clostridium difficile-associated diarrhea or disease (CDAD) and receiving oral treatment with a tiacumin compound in up to 50 to 90% of cases. The intestinal population of bifidobacteria is recovered before administration of the tiacumin compound during days 15 to 45 after the start of treatment, by administering the tiacumin compound orally to the patient according to a dosage regimen selected from the aforementioned group.
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Description

15 to 45 days after the start of treatment, by orally administering the tiacumin compound to the patient according to a dosage regimen chosen from the aforementioned group.

Claims

DEMANDS 1. Compound of tiacumin, stereoisomer thereof, cell polymorph, or pharmaceutically acceptable solvated form thereof, intended for use in the oral treatment of Clostridium difficile infections (CDI) or Clostridium difficile-associated diarrhea or disease (CDAD) in a patient according to a dosing regimen selected from the group consisting of:

10. Administration of 200 mg of the tiacumin compound twice daily for 5 days followed by 5 days of rest, then 200 mg once daily for another 10 days and 11. Administration of 200 mg of the tiacumin compound BID; for 5 days followed by a single dose of 200 mg every 2 days for 20 days.

2. A tiacumin compound intended for use according to claim 1, characterized in that the tiacumin compound is selected from the group consisting of tiacumin A, tiacumin B and its analogues (dialkyltiacumicins and bromotiacumicins), tiacumin c, tiacumin D, tiacumin E, tiacumin F and lipiarmycin.

3. A tiacumin compound intended for use according to each of claims 1 and 2, characterized in that the tiacumin compound is lipiarmycin or tiacumin B or a stereoisomer thereof.

4. A tiacumin compound intended for use according to each of claims 1 to 3, characterized in that the tiacumin compound is tiacumin B or a polymorph thereof.

5. Tiacumicin compound intended for use according to each of claims 1 to 4, characterized in that the tiacumin compound is R-tiacumicin B (fidaxomicin).

6. A tiacumin compound intended for use according to each of claims 1 to 5, characterized in that a tablet, a suspension, a dry powder for aqueous suspension, a dry granule for aqueous suspension, a film-coated tablet or a dispersible tablet is used.

7. A tiacumin compound intended for use according to each of claims 1 to 6, characterized in that a film-coated tablet is used.

8. Pharmaceutical composition, comprising a tiacumin compound, a stereoisomer thereof, a polymorph thereof or a pharmaceutically acceptable solvated form thereof, intended for use in the oral treatment of Clostridium difficile infections (CDI) or Clostridium difficile-associated diarrhea or disease (CDAD) in a patient according to a dosing regimen selected from the group consisting of: i. administration of 200 mg of the tiacumin compound twice daily for 5 days followed by 5 days of rest, then 200 mg once daily for another 10 days and 11. Administration of 200 mg of the tiacumin compound BID; for 5 days followed by a single dose of 200 mg every 2 days for 20 days.

9. Pharmaceutical composition, comprising the tiacumin compound, intended for use according to claim 8, characterized in that the tiacumin compound is selected from the group consisting of tiacumin A, tiacumin B and its analogues ؛dialkyltiacumicins and bromotiacumicins), tiacumicin C, tiacumicin D, tiacumlclne E, tiacumicin F and lipiarmycin.

10. Pharmaceutical composition, comprising the tiacumin compound, intended for use according to each of the claims 8 and 9, characterized in that the tiacumin compound is lipiarmycin or tiacumin B or a stereoisomer thereof.

11. Pharmaceutical composition. comprising the tiacumin compound, intended for use according to each of claims 8 to 10, characterized in that the compound of tiacumin is tiacumin B or a polymorph thereof.

12. Pharmaceutical composition, comprising the tiacumicin compound, intended for use according to each of claims 8 to 11, characterized in that the tiacumicin compound is R““tiacumicin B (fidaxomicin).

13. Pharmaceutical composition, comprising the tiacumin compound, intended for use according to each of claims 8 to 12, characterized in that the composition is a tablet, a suspension, a dry powder for aqueous suspension, a dry granule for aqueous suspension, a film-coated tablet or a dispersible tablet.

14. Pharmaceutical composition, comprising the tiacumin compound, intended for use according to each of claims 8 to 13, characterized in that the composition is a film-coated tablet.