Granted Patent
B2
US 12,311,026 · App. 18/606,860 · Granted May 27, 2025
Therapeutic uses for sodium thiosulfate formulations
Assignee:
Fennec Pharmaceuticals, Inc.
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Abstract
Described herein is anhydrous sodium thiosulfate, methods for synthesizing anhydrous sodium thiosulfate, pharmaceutical compositions thereof, and methods of treating ototoxicity. Anhydrous sodium thiosulfate is synthesized from sodium sulfite, sulfur, and cetylpyridinium chloride. The anhydrous sodium thiosulfate is formulated into a pharmaceutical composition comprising a buffer and solvent. These compositions are useful for eliminating or reducing ototoxicity in pediatric patients receiving platinum-based chemotherapeutics.
Claims (26)
1. A method of reducing ototoxicity in a pediatric patient receiving a platinum based chemotherapeutic for the treatment of cancer sensitive to the platinum based chemotherapeutic comprising administering an effective amount of a pharmaceutical composition comprising sodium thiosulfate at a concentration of about 0.5 M and a stabilizer or mixture of stabilizers selected from alanine, arginine, aspartic acid, histidine, lysine, proline, glucose, sucrose, trehalose, glycerol, glycine, mannitol, sorbitol, sodium sulphate, ethylenediaminetetraacetic acid (EDTA), cyclodextrin, dextran, polyethylene glycol, polyvinylpyrrolidone, and tromethamine, wherein the pharmaceutical composition is adjusted if necessary to achieve a pH between 6.5 and 8.9, and wherein the pharmaceutical composition comprises no borate ions.
2. The method of claim 1 , wherein the composition comprises a pH adjusting agent.
3. The method of claim 2 , wherein the pH adjusting agent comprises hydrochloric acid.
4. The method of claim 2 , wherein the pH adjusting agent comprises sodium hydroxide.
5. The method of claim 1 , wherein the pharmaceutical composition has a pH between 8.6 and 8.8.
6. The method of claim 1 , wherein the pediatric patient is five or fewer years of age.
7. The method of claim 1 , wherein the stabilizer is glycine.
8. The method of claim 1 , wherein the stabilizer is tromethamine.
9. The method of claim 1 , wherein the stabilizer is alanine.
10. The method of claim 1 , wherein the stabilizer is arginine.
11. The method of claim 1 , wherein the stabilizer is aspartic acid.
12. The method of claim 1 , wherein the stabilizer is histidine.
13. The method of claim 1 , wherein the stabilizer is lysine.
14. The method of claim 1 , wherein the stabilizer is proline.
15. The method of claim 1 , wherein the stabilizer is glucose.
16. The method of claim 1 , wherein the stabilizer is sucrose.
17. The method of claim 1 , wherein the stabilizer is trehalose.
18. The method of claim 1 , wherein the stabilizer is glycerol.
19. The method of claim 1 , wherein the stabilizer is mannitol.
20. The method of claim 1 , wherein the stabilizer is sorbitol.
21. The method of claim 1 , wherein the stabilizer is sodium sulphate.
22. The method of claim 1 , wherein the stabilizer is EDTA.
23. The method of claim 1 , wherein the stabilizer is cyclodextrin or dextran.
24. The method of claim 1 , wherein the stabilizer is polyethylene glycol or polyvinylpyrrolidone.
25. The method of claim 1 , wherein the platinum based chemotherapeutic is cisplatin.
26. The method of claim 25 , wherein the pharmaceutical composition is administered to the pediatric patient about 6 hours after the completion of the administration of cisplatin.
Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 23, 2025
From: RAYKOV, ROSTISLAV CHRISTOV
To: FENNEC PHARMACEUTICALS, INC.
Reel/Frame 070927/0248 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Aug 22, 2024
From: SMITH, ALEXANDER
To: ADS PHARMA CONSULTING, LLC
Reel/Frame 068374/0764 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Aug 22, 2024
From: ADS PHARMA CONSULTING, LLC
To: FENNEC PHARMACEUTICALS, INC.
Reel/Frame 068374/0804 →
Continuity (8)
Provisional Application
62693503
· Jul 3, 2018
Provisional Application
62693502
· Jul 3, 2018
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