Negative Efficacy Results from the recently completed Phase 3 study 104-201506

This is a multicenter, Phase 2 study to assess the feasibility, safety and efficacy of OTO-104 given by intratympanic administration in subjects at risk for ototoxicity from cisplatin chemotherapy regimens in the treatment of cancer.

Inclusion Criteria:

• Subject is aged 6 months to 21 years inclusive.
• Subject is diagnosed with neuroblastoma, hepatoblastoma, osteosarcoma or extracranial germ cell tumors and has not been previously treated with cisplatin or carboplatin.
• Subject is scheduled to receive a chemotherapy regimen that includes a cumulative cisplatin dose of ≥ 200 mg/m2.
• Subject has normal baseline auditory function, defined as ≤ 20 dB from 2000 to 8000 Hz, in both ears and does not have a history of sensorineural hearing loss.

Exclusion Criteria:

• Subject has middle ear effusion upon clinical examination.
• Subject has a history of central nervous system radiotherapy that encompasses all or part of the cochlea or will receive such radiation therapy during the course of the study.
• Subject is receiving sodium-thiosulfate or amifostine therapy with chemotherapy.
• Subject is currently participating on a separate otoprotection clinical study.