Auris Medical Initiating Clinical Trial with Tinnitus
Drug
We've been following Auris Medical's drugs for the prevention and
reversal of noise-induced hearing loss. It turns out that they also have
a drug that is intended to treat inner ear tinnitus. Here's the story!
~~~~~~~~~~~~~~~~~
February 2007
Auris Medical initiated its first clinical trial with AM-101, its
investigational drug for the treatment of inner ear tinnitus. The
primary objective of the double blind, randomised, placebo-controlled
trial with dose esca-lation is to evaluate the safety of
intratympanically delivered AM-101 in patients suffering from tinnitus
following acute noise trauma. The secondary objective of the study is a
preliminary evaluation of the poten-tial therapeutic benefit of AM-101.
Patients whose tinnitus set in less than three months ago and proved to
be refractory to a first-line treatment with glucocorticoids will be
enrolled in a maximum of 4 dose cohorts. The clinical trial with AM-101
will be performed at the ENT departments of four clinics of the German
Bundeswehr (Ulm, Berlin, Hamburg, Koblenz) with Professor Heinz Maier,
MD, acting as lead investigator.
About Tinnitus
Tinnitus, the perception of sound without external acoustic
stimulation, is a very common ear disorder. European population studies
estimate 7% to 14% of the population have talked with their physician
about tinnitus, while potentially disabling tinnitus occurs in
approximately 1% to 2.4% of people (Vesterarger, 1997). Tinnitus may be
short and transitory; however, it may also become permanent and
seriously impact the ability to sleep, relax, or to concentrate, or lead
to tiredness, irritation, nervousness, despair, frustration, or
depression. Until now, there exists neither a universal standard of care
for tinnitus, nor a truly proven, effective treatment method.
In most cases, tinnitus is associated with hearing loss and
originates within the inner ear. Inner ear tinnitus may be provoked by
exposure to excessive noise such as in the case of acute or repeated
acoustic trauma, sudden deafness, anoxia / ischemia, the administration
of certain ototoxic drugs or various other inner ear injuries.
About AM-101
AM-101 is a small molecule that selectively blocks NMDA receptors in
the cochlea. Based on research con-ducted at the INSERM Institute for
Neurosciences of Montpellier, France, NMDA receptors can provoke ab-errant
activity of the auditory nerve which is perceived as tinnitus. NMDA
receptors do not seem to be in-volved in fast excitatory
neurotransmission which is essential for hearing, but may be activated
due to some excitotoxic incident such as noise trauma or sudden
deafness. It could be shown in behavioural and electro-physiological
models that local administration of the NMDA antagonist AM-101 to
animals suffering from tinnitus effectively suppressed the perception of
the "phantom sound". The development of AM-101 was supported
by Oséo ANVAR, the French agency for the financing and support of small
and mid-sized busi-ness enterprises.
Auris Medical AG, Hauptstrasse 16, CH-3186 Düdingen,
www.aurismedical.com Laboratoires Auris SAS, CEEI Cap Alpha, Avenue de
l'Europe, FR-34940 Montpellier Cedex 09 Auris Medical Inc., 211 East
Ontario Street, Chicago, IL 60611, USA
About Auris Medical
Auris Medical is a Swiss-French biotechnology company developing
specific pharmaceutical compounds for the prevention or treatment of
inner ear disorders, an area of great unmet medical need. Around the
world, many million people are suffering permanently from severe hearing
loss and / or tinnitus, still lacking truly effective and safe
treatments for their disorders. Auris Medical is currently focusing on
the development of treatments for inner ear tinnitus (AM-101) and for
acute sensorineural hearing loss (AM-111).
