Otonomy Initiates Patient Enrollment in Phase 2 Clinical Trial of OTO-104 as Protectant Against Cisplatin-Induced Hearing Los...
January 19 2017 - 7:30AM
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 enrollment of the first patients in a Phase 2 clinical trial
evaluating OTO-104 for the prevention of hearing loss in cancer
patients undergoing chemotherapy with platinum-based agents. This
multicenter trial is designed to assess the feasibility, safety and
exploratory efficacy of OTO-104 given by intratympanic
administration in subjects at risk for ototoxicity from cisplatin
chemotherapy.
“The clinical evaluation of OTO-104 for the prevention of
cisplatin-induced hearing loss is a priority for us based on the
high unmet medical need, especially in the pediatric and young
adult patient populations where hearing is essential to speech
development, learning and socialization,” said David A. Weber,
Ph.D., president and CEO of Otonomy. “The preclinical
proof-of-concept study we published last year provides support for
the protective effects of OTO-104 when administered prior to both
acute and repeat administration of cisplatin.”
The Phase 2 trial is expected to enroll up to 60 subjects at
8-10 leading oncology centers in the United States. Patients will
receive an administration of OTO-104 in one ear prior to each of
the first three cisplatin treatment cycles, with the contralateral
ear as an untreated control. Safety and hearing will be assessed
throughout the trial. Additional information about the clinical
trial can be found at www.clinicaltrials.gov.
This study is part of a broader development program for OTO-104
as a treatment of various severe balance and hearing disorders.
Otonomy is also conducting two Phase 3 clinical trials for OTO-104
in Ménière's disease patients, with results expected in the second
half of 2017.
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 the 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 is conducting two Phase 3 trials, AVERTS-1 in the
United States and AVERTS-2 in Europe. 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 has also initiated a Phase 2 clinical trial for OTO-104 in
a second indication, the prevention of hearing loss associated with
cisplatin chemotherapy.
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 in pediatric patients, and has
achieved positive pivotal trial results in patients with acute
otitis externa. OTO-104 is a steroid in development for the
treatment of Ménière's disease and other severe balance and hearing
disorders. Two Phase 3 trials in Ménière's disease patients are
underway with results expected during the second half of 2017, and
a Phase 2 trial has been initiated in patients at risk for
cisplatin-induced hearing loss. 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 the future financial or operating performance of Otonomy.
Forward-looking statements in this press release include, but are
not limited to, the number of patients expected to participate in
the Phase 2 clinical trial for OTO-104 in cisplatin-induced hearing
loss, and the timing of results for the two OTO-104 Phase 3
clinical trials 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 additional financing; Otonomy's dependence on the commercial
success of OTIPRIO and the regulatory success and advancement of
additional product candidates, such as OTO-104 and OTO-311, and
label expansion indications for OTIPRIO; 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, 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; the timing and
outcome of hospital pharmacy and therapeutics reviews and other
facility reviews; the impact of coverage and reimbursement
decisions by third-party payors on the pricing and market
acceptance of OTIPRIO; Otonomy's dependence on third parties for
the manufacture of OTIPRIO and product candidates; Otonomy's
dependence on a small number of suppliers for raw materials;
Otonomy's ability to protect its intellectual property related to
OTIPRIO and its 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 10-Q filed with the Securities and Exchange
Commission (the "SEC") on November 3, 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 Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Senior Vice President
619.849.5377
heidi@canalecomm.com
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com
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