NovaBay's Aganocides Show Penetration and Efficacy in a Pre-Clinical Infected Human Nail Model of Onychomycosis
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NovaBay's Aganocides Show Penetration and Efficacy in a Pre-Clinical Infected
Human Nail Model of Onychomycosis
Data to be presented at Infectious Diseases Society of America Conference
EMERYVILLE, Calif., Oct. 30 /PRNewswire-FirstCall/ -- NovaBay Pharmaceuticals,
Inc. (NYSE-Amex: NBY) today announced that its Aganocide® compounds
demonstrate potent antifungal activity in an established pre-clinical infected
nail model of onychomycosis. The study data will be presented tomorrow at the
47th Annual Meeting of the Infectious Diseases Society of America (IDSA) in
Philadelphia.
"This model tests both the penetration of the nail as well as the
effectiveness of the compounds against the targeted fungus. What is remarkable
is that, after treatment, the Aganocide formulations were able to eradicate
the fungi grown on the other side of the nail, hence indicating not only good
penetration but a good antifungal activity against T. rubrum, the fungus
responsible for onychomycosis commonly known as nail infection," said Dr.
Behzad Khosrovi, senior vice president of product development at NovaBay.
"Nail fungus is notoriously difficult to treat predominantly due to the
inability of many topical antifungal drugs to penetrate the nail, a hurdle we
were able to overcome due to the proprietary characteristics of our
compounds."
The study "In Vitro Evaluation of Stable Derivatives of the Chlorotaurines(
)on Infected Human Nail Model as Potent Antifungal Agents for the Treatment of
Onychomycosis" tested formulations of both N,N-dichloro-2,2-dimethyltaurine
(NVC-422) and N-chloro-2,2-dimethyltaurine (NVC-612), both proprietary NovaBay
compounds, which are stable derivatives of endogenous chlorotaurines that
possess potent and rapid antimicrobial activity against a wide range of
pathogens. The endogenous chlorotaurines play an important role in mammalian
innate immunity to invading pathogens.
"Onychomycosis represents a significant market opportunity for any topical
agent," said Ron Najafi, Ph.D., chairman and chief executive officer of
NovaBay. "We are encouraged by these preclinical results, especially given the
rigor of the MedPharm model and its established and predictive value."
In this model, developed and conducted by MedPharm LTD, Surrey, United
Kingdom, formulations of both NVC-422 and NVC-612 were highly effective
against Trichophyton rubrum, the fungus commonly found in nail infections and
normally very difficult to eradicate. A laboratory-cultured clinical isolate
of T. rubrum was used to infect full thickness sterile human nails in
specially constructed cells. After 14-days of incubation, single applications
of the Aganocide formulations were applied to the nail surface opposite from
the infected side. After seven more days of incubation, the nails were
analyzed for the presence of adenosine triphosphate (ATP) as a measure of
fungal viability. Uninfected nails, infected untreated nails and placebo
treated nails were used as controls.
Conference Call and Webcast Information
NovaBay will host an investor webcast and conference call to discuss the
onychomycosis data.
Date/time of live call: Friday October 30, 2009, 10:00 AM eastern time
US/Canada dial-in: (877) 862-4241 / international dial-in: (281) 312-0948
US/Canada replay: (800) 642-1687 / international replay: (706) 645-9291
Passcode for live and archived conference call is 37797881
For the live and archived webcast, please visit the Investor Events page on
the NovaBay website at www.novabaypharma.com. The webcast will be archived for
90 days and the telephone replay for seven days.
About Onychomycosis
Onychomycosis is the infection of the nail plate/bed by a fungus. Although
onychomycosis is considered a cosmetic condition, it can cause acute pain
while the physical manifestations of the infection often have adverse social
and occupational ramifications for affected patients. As such, onychomycosis
is an infection that warrants an effective medical treatment. According to
Podiatry Today, over 35 million people in the United States have
onychomycosis. Estimates indicate that up to 50% of those affected by the
disease do not receive treatment. Systemic treatments represent well over 80%
of the market today, but have potential severe liver toxicity issues, and have
shown to have relapse rates of 40% or higher.
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,
first-in-class, small molecule, patented new chemical entities 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, including its multi-drug resistant strains (such as MRSA),
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 and
tolerability as well as dosing versatility and flexibility.
About NovaBay
NovaBay Pharmaceuticals is a clinical 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(TM) and Aganocide® are trademarks of NovaBay
Pharmaceuticals, Inc. For more information on NovaBay, visit:
www.novabaypharma.com.
Cautionary Information Regarding Forward-Looking Statements
The statements in this press release regarding NovaBay's expectations of the
potential for its product candidates to address onychomycosis, the market
opportunity for onychomycosis, and the potential benefits of NovaBay's
Aganocide products, are forward-looking statements subject to risks and
uncertainties. Actual results may be different than those NovaBay expects due
to a number of factors, including the risk that results in pre-clinical trials
will not be replicated in clinical trials, and other risks relating to NovaBay
and its Aganocide compounds, detailed in NovaBay's Quarterly Report on Form
10-Q, under the caption "Risk Factors" in Item 1A of Part II of that report,
which was filed with the Securities and Exchange Commission on August 14,
2009.
SOURCE NovaBay Pharmaceuticals, Inc.
Tom Paulson, Chief Financial Officer of NovaBay Pharmaceuticals, Inc.,
+1-510-899-8809, tpaulson@novabaypharma.com; or media, Aimee Corso,
+1-503-855-4502, acorso@wcpglobal.com, for NovaBay Pharmaceuticals, Inc.
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