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.
CONTACT: 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.
Web Site: http://www.novabaypharma.com/
Posted: November 2009
