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news.Sound Pharmaceuticals has filed an investigational new drug application with the FDA for the clinical testing of a proprietary formulation of ebselen for the prevention of chemotherapy induced hearing loss or ototoxicity.
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The oral capsule containing ebselen, SPI-3005, will be tested in advanced stage lung cancer and head and neck cancer patients receiving platinum based chemotherapy.
This marks the second development program for SPI to enter clinical testing for a hearing loss indication. In 2007, SPI-1005, an oral capsule containing ebselen entered Phase II testing with the US Navy for the prevention and treatment of noise induced hearing loss.
Eric Lynch, vice president of Sound Pharmaceuticals, said: “A dose limiting side effect of platinum based chemotherapies are their devastating ototoxicity and neurotoxicity, and SPI-3005 is designed to attenuate these side effects without inhibiting the therapeutic efficacy of platinum or taxane based chemotherapies.”