Alcon, Inc. (NYSE: ACL)
and its partner, NovaBay Pharmaceuticals, Inc. (NYSE-AMEX: NBY),
announced today that Alcon has begun treating patients in a Phase 2
clinical trial of NovaBay’s patented lead Aganocide®
compound, NVC-422, for viral conjunctivitis, a type of "pink eye.”
Conjunctivitis is a pervasive and painful condition that affects both
adults and children, leading to more than four million doctor and
emergency room visits in the United States each year.
NovaBay has a licensing and research collaboration agreement with Alcon,
the world’s leading eye care company, for use of its Aganocide®
compounds in the eye, ear and sinus, and in contact lens solutions.
Developed by NovaBay to mimic the body’s defense against infection,
Aganocides® are proprietary synthetic analogs of the same
molecules used by white blood cells to destroy harmful microbes in the
body, such as viruses and bacteria. Because of their natural mechanism
of action, NovaBay believes that Aganocide® compounds have a
low potential for generating microbial resistance, offering a potential
solution to the problem of rising resistance of microbes to traditional
antibiotics.
The Phase 2 viral conjunctivitis study follows a recently completed
Phase 1 trial in which safety and tolerability were successfully
demonstrated in 120 healthy volunteers with no reported serious adverse
events.
"We are pleased to be entering mid-stage clinical testing for viral
conjunctivitis,” said Ron Najafi, Ph.D., chairman and chief executive
officer of NovaBay. "This is the first step in the ophthalmic clinical
development program for NVC-422, which has the immediate goal of
developing the first effective product to address viral conjunctivitis
for which there are limited treatment options.”
The Phase 2 multi-center, randomized, placebo-controlled trial is
designed to determine the safety and efficacy of NVC-422 in people with
viral conjunctivitis. The study calls for enrolling approximately 250
patients at more than 30 medical centers, mostly in the United States.
"This study is an important step forward with the clinical program for
this potentially dual-acting therapy to address the multiple causes of
conjunctivitis. Dual action against viral and bacterial conjunctivitis
is important because when an infection is diagnosed it is difficult,
time-consuming and expensive to determine the underlying cause of the
infection and treat it properly," said Dr. Sabri Markabi, M.D., Alcon’s
senior vice president of research and development and chief medical
officer.
About Conjunctivitis
Conjunctivitis, which can result from either viral or bacterial
infection, is an inflammation of the thin, clear tissue that covers the
white part of the eye and forms the inside lining of the eyelid. The
viral disease is principally caused by adenoviruses, but also can be
caused by other viruses, such as enterovirus. There is no specific
treatment for adenoviral conjunctivitis, which can take up to three
weeks or longer to clear on its own. Bacterial conjunctivitis is caused
by a variety of bacteria and is largely treated with topically applied
antibiotic eye drops. Regular innovation to develop newer antibiotics is
required because over time antibiotics may encounter increasing
bacterial resistance.
About Aganocide® Compounds
The Aganocide® compounds are novel, proprietary, synthetic
N-chlorinated antimicrobial molecules specifically developed by NovaBay
to mimic the body’s natural defense against infection. The Aganocide®
compounds maintain the biological activities while improving the
stability of naturally occurring N-chlorinated antimicrobial molecules.
These highly differentiated compounds may deliver the same or better
efficacy than currently used antibiotics without contributing to the
growing rise of antibiotic-resistant bacterial strains. In preclinical
testing, the Aganocide® compounds have been shown to be
highly effective against bacteria, viruses and fungi. They also have
been demonstrated to be effective against bacteria in biofilms, which
render most antibiotics ineffective. Aganocides have a broad therapeutic
index while providing a high degree of potency, good tolerability as
well as dosing versatility and flexibility.
About Alcon
Alcon, Inc. is the world's leading eye care company, with sales of
approximately $6.3 billion in 2008. Alcon, which has been dedicated to
the ophthalmic industry for more than 65 years, researches, develops,
manufactures and markets pharmaceutical products, surgical equipment and
devices, contact lens care solutions and other vision care products that
treat diseases, disorders and other conditions of the eye. For more
information on Alcon, Inc., visit the Company's web site at www.alcon.com.
About NovaBay
NovaBay Pharmaceuticals is a mid-stage biopharmaceutical company focused
on developing its proprietary and patented Aganocide®
compounds, which are novel, synthetic anti-infective product candidates
that are bioequivalent to the active antimicrobial molecules generated
within white blood cells to treat and prevent a wide range of infections
without causing bacterial resistance. NovaBay has internal development
programs aimed at addressing hospital and respiratory infections. The
company has a licensing and research collaboration agreement with Alcon,
Inc. for use of its Aganocide® compounds to treat eye, ear
and sinus infections as well as in contact lens care solutions. NovaBay
has also entered into an agreement with Galderma S.A. to develop and
commercialize Aganocides in acne, impetigo and other dermatological
indications. NovaBay® and Aganocide® are
trademarks of NovaBay Pharmaceuticals, Inc. For more information on
NovaBay, visit: www.novabaypharma.com.
Forward-Looking Statements
The statements in this press release regarding NovaBay’s and Alcon’s
expectations regarding the clinical trial and the potential efficacy of
Aganocide® compounds are forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995. The
forward- looking statements reflect the views of the management of
NovaBay and Alcon as of the date of this press release with respect to
future events and are based on assumptions and subject to significant
risks and uncertainties (many of which are outside of NovaBay’s or
Alcon’s control), including the risk that FDA or other regulatory review
may delay or prevent the development of Aganocide® compounds,
and those detailed in the NovaBay’s and Alcon’s filings with the
Securities and Exchange Commission. Given these uncertainties, you
should not place undue reliance on these forward-looking statements.
Except to the extent required under the federal securities laws and the
rules and regulations promulgated by the Securities and Exchange
Commission, we undertake no obligation to publicly update or revise any
of these forward-looking statements, whether to reflect new information
or future events or circumstances or otherwise.
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