PURE Bioscience and Therapeutics, Inc. Expand Silver Dihydrogen Citrate Pharmaceutical Product Development Initiative to Includ
02 Maio 2006 - 9:30AM
PR Newswire (US)
First IND Filing With the US FDA Expected in Approximately Six
Months SAN DIEGO, May 2 /PRNewswire-FirstCall/ -- PURE Bioscience
(OTC:PURE) (BULLETIN BOARD: PURE) announced today the expansion of
its joint development initiative with Therapeutics, Inc. to include
development of PURE's silver dihydrogen citrate (SDC)
broad-spectrum antimicrobial as an active pharmaceutical ingredient
in products for treatment of dermatophytoses such as Tinea pedis
(athlete's foot), onychomycosis (nail fungus), among others, as
well as development of antimicrobial skin wash products, beginning
with a hand sanitizer. PURE and Therapeutics anticipate filing five
formal submissions for Investigational New Drug Applications (INDs)
with the US FDA over the next twenty-four months, beginning with an
IND for the hand sanitizer in the fourth calendar quarter this
year. In addition to the hand sanitizer, athlete's foot and nail
fungus programs, Therapeutics is already pursuing SDC-based
anti-acne and vaginal anti-infective pharmaceutical development
programs. (Logo:
http://www.newscom.com/cgi-bin/prnh/20060119/LATH060LOGO ) The
companies anticipate IND filings for bacterial vaginosis, a lead
dermatophytoses indication (athlete's foot/nail fungus) and acne in
2007. In addition, to optimize development of these products, the
companies may also consider Ex-US development strategies. Daniel
Piacquadio, MD, CEO of Therapeutics stated, "The chemical
characterization work for the SDC-based active pharmaceutical
ingredient has been substantially completed, a wide variety of
prototype product formulations have been developed, and in-vitro
and in vivo toxicology, including genotoxicity testing, has begun.
We remain very encouraged by the progress to date. Given the
increasing concern over global infection control, we believe the
new hand sanitizer may provide a timely and valuable tool to help
in the fight against the transmission of infectious agents and
disease." Michael L. Krall, President and CEO of PURE Bioscience
added, "During the last twelve months, Therapeutics has made
important progress demonstrating SDC's potential as a novel
therapeutic treatment for several human diseases and conditions,
and we are eager to move forward with the FDA submissions to
advance our longer term strategy of marketing SDC as an active
pharmaceutical ingredient," stated Michael L. Krall, President and
CEO of PURE Bioscience. We are beginning to capitalize on our SDC
technology with our EPA registered SDC hard surface disinfectant,
while also expanding sales of SDC concentrate for integration as a
preservative or active antimicrobial ingredient in third party
products." Therapeutics has elected to focus on development of
SDC-based products for the treatment and prevention of
dermatological and women's health related bacterial, viral and
fungal mediated diseases and conditions and has assumed
responsibility for funding and managing the testing and regulatory
processes for selected potential FDA-regulated SDC-based products.
PURE's SDC technology also shows promise as a broad-spectrum
antimicrobial for multiple other medical indications, including
wound and burn care, as well as for dental and veterinary
indications, and PURE is currently seeking additional partners to
investigate further healthcare product development. Silver
Dihydrogen Citrate: Remarkable Platform Technology PURE's flagship
bioscience technology is an aqueous antimicrobial, silver
dihydrogen citrate (SDC). A patented new molecule, SDC is an
electrolytically generated source of stabilized ionic silver that
can serve as the basis for a broad range of products in diverse
markets. SDC liquid is colorless, odorless, tasteless, non-caustic
and formulates well with other compounds. As a platform technology,
SDC is distinguished from competitors in the marketplace because of
its superior efficacy combined with reduced toxicity. PURE's first
commercialized product, an SDC-based hard surface disinfectant, is
marketed to commercial, industrial and consumer markets including
restaurants, homes and medical facilities. The hard surface
disinfectant EPA registration includes a 30 second kill time on
standard indicator bacteria, a 24 hour residual kill on standard
indicator bacteria, a 2 minute kill time on some resistant strains
of bacteria, 10 minute kill time on fungi, 30 second kill time on
HIV Type I, and 10 minute kill time on other pathogenic viruses.
These claims distinguish the efficacy of PURE's disinfectant from
many of the leading commercial and consumer products currently on
the market, while maintaining lower toxicity ratings. Based on the
EPA toxicity categorization of antimicrobial products that ranges
from Category I (high toxicity) down to Category IV, PURE's
disinfectant is an EPA Category IV antimicrobial for which
precautionary labeling statements are normally not required. This
compares with Category II warning statements for most leading
brands of disinfectant products. PURE has begun initial sales of
SDC concentrate for integration as a preservative or active
antimicrobial ingredient in existing third party products. PURE
expects to realize revenues not only from raw material sales but
also from licensing and/or royalties. Longer-term revenues are
expected from the inclusion of SDC as a broad-spectrum
antimicrobial for use in pharmaceutical, dental and veterinary
products. PURE is initially pursuing approvals through the U.S.
Food and Drug Administration (FDA) with its partner Therapeutics,
Incorporated, which is funding and managing the testing and
regulatory process for at least five potential FDA regulated
SDC-based products. About Therapeutics, Incorporated Therapeutics,
Incorporated of San Diego, California is a private, internationally
recognized research and development corporation dedicated to
product success through integration of innovative clinical and
regulatory strategies, sound trial design, schedule-driven product
development and competitive marketplace analysis. Focusing on new
technologies, with an emphasis in topical drug development,
Therapeutics, Incorporated manages all aspects of product
development from the "bench top" to the physician's office.
Therapeutics, Incorporated applies the expertise of seasoned
scientists and clinicians to create project specific development
plans executed in a milestone-driven project management style.
Visit http://www.therapeuticsinc.com/ for more information. About
PURE Bioscience PURE Bioscience (PURE) develops and markets
technology-based bioscience products that provide non-toxic
solutions to numerous global health challenges. PURE's proprietary
high efficacy/low toxicity bioscience technologies, including its
silver dihydrogen citrate-based antimicrobials and boric acid-based
pesticides, represent innovative advances in diverse markets and
lead today's global trend toward industry and consumer use of
"green" products while providing competitive advantages in efficacy
and safety. PURE Bioscience, headquartered in El Cajon, California,
(San Diego metropolitan area), was incorporated in 1992. For
additional information on PURE Bioscience, visit the Company's
website: http://www.purebio.com/. This press release includes
statements that may constitute "forward-looking" statements,
usually containing the words "believe", "estimate", "project",
"expect" or similar expressions. These statements are made pursuant
to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements inherently involve
risks and uncertainties that could cause actual results to differ
materially from the forward-looking statements. Factors that would
cause or contribute to such differences include, but are not
limited to, acceptance of the Company's current and future products
and services in the marketplace, the ability of the Company to
develop effective new products and receive regulatory approvals of
such products, competitive factors, dependence upon third-party
vendors, and other risks detailed in the Company's periodic report
filings with the Securities and Exchange Commission. By making
these forward-looking statements, the Company undertakes no
obligation to update these statements for revisions or changes
after the date of this release. Investor Contact: Terri MacInnis,
Bibicoff & Associates, Inc. 818-379-8500 Media Contact: Karen
Kristofferson, Mentus 858-455-5500 x 275
http://www.newscom.com/cgi-bin/prnh/20060119/LATH060LOGO
http://photoarchive.ap.org/ DATASOURCE: PURE Bioscience CONTACT:
Investors, Terri MacInnis of Bibicoff & Associates, Inc.
+1-818-379-8500, , for PURE Bioscience; or Media, Karen
Kristofferson of Mentus, +1-858-455-5500 ext. 275, , for PURE
Bioscience Web site: http://www.therapeuticsinc.com/ Web site:
http://www.purebio.com/
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