Sound Pharmaceuticals (SPI) 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. Last year, 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.
Currently there are no FDA approved drugs for the prevention and
treatment of drug induced hearing loss or ototoxicity. SPI hopes to address
this unmet medical need with its first in class first in indication drug.
Several different research groups have shown that chemotherapy treatment
reduces glutathione peroxidase (GPx) activity in the mammalian inner ear
resulting in hearing loss, tinnitus, vertigo and dizziness. GPx is the
dominant catalytic antioxidant enzyme within the inner ear, and a loss of
its activity results in irreparable damage to hair cells, neurons and
non-sensory tissues that are critical for hearing and balance. "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," said VP Eric Lynch, PhD.
"Otoprotectants such as SPI-3005 have the potential to reduce and/or
alleviate chemotherapy-induced ototoxicity, and clinical studies should be
pursued," said Stephen Fausti, PhD, and Director of the National Center for
Rehabilitative Auditory Research (NCRAR) at the Portland VA, Professor of
Otolaryngology and Neurology at Oregon Health Sciences University.
Sound Pharmaceuticals, Inc., is a privately held biopharmaceutical
company with a focus on developing the first drugs for hearing loss and
brain injury.
Sound Pharmaceuticals
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