Otonomy Announces Publication Supporting Development of OTO-104 as Protectant Against Cisplatin-Induced Hearing Loss
January 26 2016 - 7:05AM
Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company
focused on the development and commercialization of innovative
therapeutics for diseases and disorders of the ear, today announced
the publication in Audiology & Neurotology of a preclinical
study titled, “The Sustained-Exposure Dexamethasone Formulation
OTO-104 Offers Effective Protection against Cisplatin-Induced
Hearing Loss”. This study demonstrated that intratympanic
administration of 6% OTO-104 protected against ototoxicity observed
following both acute and repeat administration of the
chemotherapeutic agent cisplatin.
“Our recent financing enables us to expand the scope of our
development efforts, and the clinical evaluation of OTO-104 for the
prevention of cisplatin-induced hearing loss is a priority based on
the high unmet medical need, attractive market potential, and
preclinical proof-of-concept presented in this publication,” said
David A. Weber, Ph.D., president and CEO of Otonomy. “We have
completed a pre-IND review by the FDA and expect to initiate a
Phase 2 feasibility trial at multiple leading oncology centers in
the second half of 2016.”
“Hearing loss caused by cancer treatment with platinum-based
chemotherapy agents is well documented, and the negative impact on
the quality of life of cancer survivors, especially children and
adolescents, is highly significant,” said Dr. David Freyer,
Professor of Clinical Pediatrics and Medicine at the Keck School of
Medicine, University of Southern California, and Director,
Survivorship and Supportive Care Program of the Children’s Center
for Cancer and Blood Diseases at Children’s Hospital of Los
Angeles. “There is great interest among pediatric oncologists,
hearing specialists, and parents in having a therapeutic agent that
can protect against hearing loss without concern for interfering
with the effectiveness of the chemotherapy. Otic delivery of
OTO-104 has this potential based on the preclinical profile in this
study.”
About Cisplatin-Induced Hearing Loss
Cisplatin and other platinum-based chemotherapeutic agents are
routinely used in treating numerous tumor types with approximately
500,000 patients including 2,000 children treated each year in the
United States. While use of platinum agents has contributed to
improved patient survival, ototoxicity and associated permanent
hearing loss is well documented in the clinical literature. In
particular, hearing loss has been reported in up to 90% of children
and young adults treated with platinum-based agents1. This
adversely affects speech and language development and has been
associated with academic and social difficulties. At this time,
there is no FDA-approved drug treatment to protect against
platinum-based ototoxicity.
1Landier et al., Journal of Clinical Oncology, 2014.
About OTO-104
OTO-104 is a sustained-exposure formulation of the steroid
dexamethasone in development for the treatment of various severe
balance and hearing disorders. The first indication being pursued
is Ménière's disease which is a chronic condition characterized by
acute vertigo attacks, tinnitus, fluctuating hearing loss and a
feeling of aural fullness. Based on supportive results from a Phase
2b trial, Otonomy has initiated a Phase 3 program. The first Phase
3 trial is underway in the United States and a second trial is
expected to be initiated in the EU during the first quarter of
2016. Results of both Phase 3 trials are expected in the second
half of 2017. OTO-104 has been granted Fast Track designation for
this indication by the FDA. Otonomy also intends to initiate
clinical development for OTO-104 in a second indication, the
prevention of hearing loss associated with cisplatin chemotherapy.
Otonomy expects to initiate a Phase 2 feasibility clinical trial
for OTO-104 in this indication in the second half of 2016.
About Otonomy
Otonomy is a biopharmaceutical company focused on the
development and commercialization of innovative therapeutics for
diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic
suspension) is approved in the United States for use during
tympanostomy tube placement surgery and commercial launch is
expected in the first quarter of 2016. OTO-104 is a steroid in
development for the treatment of Ménière's disease and other severe
balance and hearing disorders. A Phase 3 trial in Ménière's disease
patients is underway in the United States with a second trial
expected to be initiated in the EU during the first quarter of
2016. OTO-311 is an NMDA receptor antagonist for the treatment of
tinnitus that is in a Phase 1 clinical safety trial. Otonomy’s
proprietary formulation technology utilizes a thermosensitive gel
and drug microparticles to enable single dose treatment by a
physician. For additional information please visit
www.otonomy.com.
Cautionary Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements generally relate to future events
or future financial or operating performance of Otonomy.
Forward-looking statements in this press release include, but are
not limited to, Otonomy's expectations regarding the timing of
commercial launch of OTIPRIO, the timing of the OTO-104 Phase 2
feasibility clinical trial for cisplatin-induced hearing loss, the
timing of the OTO-104 Phase 3 clinical trial for Ménière's disease
in the EU, and the timing of Phase 3 clinical trial results for
OTO-104 in Ménière's disease. Otonomy's expectations regarding
these matters may not materialize, and actual results in future
periods are subject to risks and uncertainties. Actual results may
differ materially from those indicated by these forward-looking
statements as a result of these risks and uncertainties, including
but not limited to: Otonomy's limited operating history and its
expectation that it will incur significant losses for the
foreseeable future; Otonomy's ability to obtain substantial
additional financing; Otonomy's dependence on the regulatory and
commercial success of OTIPRIO and OTO-104 and advancing additional
product candidates, such as OTO-311; the uncertainties inherent in
the clinical drug development process, including, without
limitation, Otonomy's ability to adequately demonstrate the safety
and efficacy of its product candidates, the preclinical and
clinical results for its product candidates, which may not support
further development of product candidates, and challenges related
to patient enrollment in clinical trials; Otonomy's ability to
obtain regulatory approval for its product candidates; side effects
or adverse events associated with Otonomy's product candidates;
competition in the biopharmaceutical industry; Otonomy's dependence
on third parties to conduct preclinical studies and clinical
trials; Otonomy's dependence on third parties for the manufacture
of products; Otonomy's dependence on a small number of suppliers
for raw materials; Otonomy's ability to protect its intellectual
property related to product candidates in the United States and
throughout the world; expectations regarding potential market size,
opportunity and growth; Otonomy's ability to manage operating
expenses; implementation of Otonomy's business model and strategic
plans for its business, products and technology; and other risks.
Information regarding the foregoing and additional risks may be
found in the section entitled "Risk Factors" in Otonomy's Quarterly
Report on Form 8-K filed with the Securities and Exchange
Commission (the "SEC") on January 5, 2016, and Otonomy's future
reports to be filed with the SEC. The forward-looking statements in
this press release are based on information available to Otonomy as
of the date hereof. Otonomy disclaims any obligation to update any
forward-looking statements, except as required by law.
Contacts:
Media InquiriesCanale CommunicationsHeidi Chokeir, Ph.D.Senior
Vice President619.849.5377heidi@canalecomm.com
Investor InquiriesWestwicke PartnersRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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