July 24, 2008
Sound Pharmaceuticals Files Second IND Application for Ototoxicity Drug
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.
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."