Sound Pharmaceuticals Files Second IND with the FDA
Editor: Sound Pharmaceuticals is developing drugs that are intended to
prevent or reverse hearing loss, and they have recently been seeking FDA
approval for uses of some of these drugs. Here's their press release
regarding one of these requests.
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August 2008
Request Approval for the Prevention of Chemotherapy Induced Hearing
Loss in Advanced Stage Cancer
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. For more information please contact Jonathan Kil, MD, President
and CEO, 206- 634-2559 or http://www.soundpharma.com.
