SAN DIEGO, May 2 /PRNewswire-FirstCall/ -- PURE Bioscience 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.
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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 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: 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 terrimac@bibicoff.com Media Contact: Karen Kristofferson, Mentus 858-455-5500 x 275 karen@mentus.com
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CONTACT: Investors, Terri MacInnis of Bibicoff & Associates, Inc.+1-818-379-8500, terrimac@bibicoff.com, for PURE Bioscience; or Media,Karen Kristofferson of Mentus, +1-858-455-5500 ext. 275, karen@mentus.com,for PURE Bioscience
