PURE Bioscience Announces First FDA Investigational New Drug Application for Silver Dihydrogen Citrate
2007年2月1日 - 10:00PM
PRニュース・ワイアー (英語)
Therapeutics, Incorporated to Commence Pilot Studies on Hand
Sanitizer SAN DIEGO, Feb. 1 /PRNewswire-FirstCall/ -- PURE
Bioscience (OTC:PURE) (BULLETIN BOARD: PURE) , a technology based
bioscience company, and Therapeutics, Inc., a privately held
research and development corporation, today announced the filing of
an Investigational New Drug (IND) application with the U.S. Food
and Drug Administration (FDA) by Therapeutics for a hand sanitizer
based upon PURE's patented silver dihydrogen citrate (SDC) broad-
spectrum antimicrobial. Therapeutics, Inc. submitted the IND in
late December 2006 on behalf of the PURE Bioscience/Therapeutics,
Inc. collaboration to enable initiation of the first clinical trial
of a product containing SDC as an active pharmaceutical ingredient.
After reviewing the submission the FDA has determined the product
testing in man may begin as proposed. (Logo:
http://www.newscom.com/cgi-bin/prnh/20060119/LATH060LOGO) "We are
pleased to start 2007 with such an important development," stated
Michael L. Krall, CEO of PURE Bioscience. The filing of an IND
marks a major milestone in our growth plan as we expand beyond our
EPA registered hard surface disinfectants to pharmaceutical
applications of SDC. After months of development and formulation
work with Therapeutics, Inc., we are very gratified to clear this
hurdle with the FDA in our efforts to develop and commercialize the
first human application for SDC." "Therapeutics looks forward to
initiating clinic trials of the hand sanitizer containing SDC. We
recognize the potential of this type of product and the benefit it
may hold for health care providers and patients," stated Daniel
Piacquadio, M.D., CEO of Therapeutics, Inc. PURE and Therapeutics'
joint development initiative is intended to capitalize on the
pharmaceutical potential of PURE's flagship bioscience technology,
an aqueous antimicrobial, silver dihydrogen citrate (SDC). A
patented new molecular entity, 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, non-caustic and formulates well with other
compounds. PURE granted Therapeutics a license to develop five
SDC-based products for the treatment and prevention of
dermatological and women's health related bacterial, viral and
fungal mediated diseases and conditions. Therapeutics has assumed
responsibility for funding and directing the testing and regulatory
processes for these selected potential FDA-regulated SDC-based
products and anticipates filing four additional product INDs over
the next 23 months. About PURE Bioscience PURE Bioscience (PURE)
develops and markets technology-based bioscience products that
provide solutions to numerous global health challenges. PURE's
proprietary high efficacy/low toxicity bioscience technologies,
including its silver dihydrogen citrate-based antimicrobials
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/. 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. 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 Sparks, 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, ; or media, Karen Sparks of Mentus,
+1-858-455-5500, ext. 275, , both for PURE Bioscience Web site:
http://www.purebio.com/ http://www.therapeuticsinc.com/
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