Claims for Patent: 10,596,190

Summary for Patent: 10,596,190

Title:	Method for reducing ototoxicity in pediatric patients receiving platinum-based chemotherapy
Abstract:	Described herein is a method for eliminating or reducing ototoxicity in patients receiving a platinum based chemotherapeutic. In particular, are methods of reducing ototoxicity in a pediatric patient. The methods described herein include administering an effective amount of sodium thiosulfate to a patient in need thereof to reduce ototoxicity.
Inventor(s):	Edward A. Neuwelt
Assignee:	US Department of Veterans Affairs
Application Number:	US16/112,195
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,596,190
Patent Claims:	1. A method of reducing ototoxicity in a pediatric patient of about 5 years of age and under, comprising: administering: (I) cisplatin to treat a localized and non-metastatic tumor at a dose of about 1 mg/kg to about 5 mg/kg or about 10 mg/m2 to about 300 mg/m2 per cycle, administered on between about 1 and 5 days per cycle; and (II) sodium thiosulfate, at a dose of about 5 g/m2 to about 25 g/m2 given after each dose of the cisplatin on between about 1 and 5 days per cycle, about six hours after the administration of the cisplatin, wherein the reduction of ototoxicity is at least 50% better than a patient not receiving an administration of sodium thiosulfate; wherein ototoxicity is determined by one or more criteria selected from: a) a reduction in hearing measured by a 20 dB loss at a single frequency; b) a reduction in hearing measured by a 10 dB loss at two consecutive frequencies; c) loss of response at three consecutive test frequencies where responses were previously obtained; d) a reduction in bilateral high-frequency hearing characterized by the criteria: i) a <40 dB hearing loss at all frequencies, which indicates a grade 0 or minimal hearing loss; ii) a ≥40 dB hearing loss at 8,000 Hz only, which indicates a grade 1 or mild hearing loss; iii) a ≥40 dB hearing loss at 4,000 Hz and above, which indicates a grade 2 or moderate hearing loss; iv) a ≥40 dB hearing loss at 2,000 Hz and above, which indicates a grade 3 or marked hearing loss; v) a ≥40 dB hearing loss at 1,000 Hz and above, which indicates a grade 4 or severe hearing loss; or e) a reduction in hearing characterized by the criteria: i) a ≤20 dB hearing loss at all frequencies, which indicates a grade 0 hearing loss; ii) a >20 dB HL above 4,000 Hz, which indicates a grade 1 hearing loss; iii) a >20 dB HL at 4,000 Hz and above, which indicates a grade 2 hearing loss; iv) a >20 dB HL at 2,000 Hz or 3,000 Hz, which indicates a grade 3 hearing loss; v) a >40 dB HL at 2,000 Hz and above, which indicates a grade 1 hearing loss; wherein a change in hearing is computed relative to baseline measures prior to the patient receiving a platinum based chemotherapeutic or sodium thiosulfate or both; and wherein the administration of sodium thiosulfate does not substantively affect relapse free survival or overall survival compared to a pediatric patient not administered sodium thiosulfate.