Sodium thiosulphate

38828006

New Medicines

Pedmark · Hearing loss due to cisplatin chemotherapy in children - prevention

Information

Pedmark
Licence extension / variation
Fennec
Fennec

Development and Regulatory status

Phase III Clinical Trials
None
Phase III Clinical Trials
Yes

Category

Sodium thiosulfate is a chemoprotectant/antioxidant. It inactivates platinum complexes by binding electrophilic platinum with with thiol, thus forming a covalent complex that is not cytotoxic and can be excreted rapidly.
Platinum compounds, such as cisplatin, have significant adverse effects including ototoxicity and associated permanent hearing loss. The effect of hearing loss in young children is significant and can influence speech and language development, educational achievement, and social-emotional development. Approximately 60% of children treated with cisplatin develop permanent bilateral hearing loss.
Hearing loss due to cisplatin chemotherapy in children - prevention
Intravenous

Hearing loss due to chemotherapy

Information

Licence extension / variation
Hope Pharmaceuticals
Hope Pharmaceuticals

Development and Regulatory status

None
None
Pre-registration (Filed)

Jun 18: Hope Pharmaceuticals files sNDA for treatment of patients with chemotherapy induced damage in USA [1].

Category

Sodium thiosulfate is a chemoprotectant/antioxidant. It inactivates platinum complexes by binding electrophilic platinum with with thiol, thus forming a covalent complex that is not cytotoxic and can be excreted rapidly.
Platinum compounds, such as cisplatin, have significant adverse effects including ototoxicity and associated permanent hearing loss. The effect of hearing loss in young children is significant and can influence speech and language development, educational achievement, and social-emotional development. Approximately 60% of children treated with cisplatin develop permanent bilateral hearing loss.
Hearing loss due to chemotherapy
Intravenous

Calciphylaxis - treatment of associated pain in chronic haemodialysis patients

Information

Licence extension / variation
Hope Pharmaceuticals
Hope Pharmaceuticals

Development and Regulatory status

None
None
Phase III Clinical Trials
Yes
Yes

Category

The mechanism by which sodium thiosulfate treats calciphylaxis is not clear. Sodium thiosulfate induces calcium removal through chemical chelation, and thus reduces the risk factor of dysregulation of the calcium and phosphorous metabolism.
Prevalence of calciphylaxis is estimated to be 5.0 per 100,000 population; using the latest midyear population estimates for England Wales this would equate to 2,919 persons. The UK Calciphylaxis Study states that calciphylaxis occurs in about one case per year for every 600 dialysis patients in the UK; there are estimated to be around 30,000 people on dialysis in the UK, which equates to 50 cases per year [3].
Calciphylaxis - treatment of associated pain in chronic haemodialysis patients
Intravenous