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PURE Bioscience to Begin Development of FDA Compliant Operation for Production of Pharmaceutical Grade Silver Dihydrogen Citrate.


SAN DIEGO -- PURE Bioscience (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:PURE) today announced that it will begin conversion of part of its existing manufacturing space to a dedicated FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 compliant current Good Manufacturing Practices (cGMP) facility for the production of pharmaceutical grade silver dihydrogen citrate.

Michael L. Krall, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of PURE Bioscience, stated, "As we move forward with testing and regulatory work on silver dihydrogen citrate for use in prescription and personal care products, we are required to produce silver dihydrogen citrate raw material in compliance with the FDA's Good Manufacturing Practices. Fortunately, the space required to produce silver dihydrogen citrate concentrate is small, so design and construction costs are economical."

Krall continued, "To ensure the integrity of the project, we have engaged former PURE Director, Dr. Eugene Peiser, President of Peiser & Associates, Inc., one of the nation's most respected FDA Regulatory Compliance consulting firms, to guide us through this project. Dr. Peiser will make certain that our plant and processes are in compliance with FDA rules and regulations."

PURE Bioscience's flagship technology is a patented, aqueous antimicrobial called silver dihydrogen citrate (SDC SDC Silver Dollar City
SDC Security Door Controls
SDC Student Development Center
SDC San Diego Chargers
SDC Science Data Center
SDC System Development Charges
SDC Studebaker Drivers Club
SDC San Diego, California (border patrol sector) 
). 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. Colorless, odorless, tasteless and non-caustic, SDC formulates well with other compounds. PURE produces and markets pre-formulated, ready-to-use product, as well as varying strengths of SDC concentrate as an additive or raw material for inclusion in other companies' products.

PURE's silver dihydrogen citrate technology shows promise as a broad-spectrum antimicrobial for use in human and veterinary healthcare products. PURE has chosen to pursue approvals through the U.S. Food and Drug Administration (FDA) by partnering with Therapeutics, Incorporated, which has assumed responsibility for funding and managing the testing and regulatory process for potential FDA regulated silver dihydrogen citrate-based products. Therapeutics, Incorporated is focusing on development of silver dihydrogen citrate-based products for the treatment of bacterial, viral and fungal mediated diseases and conditions, beginning with women's health products and acne treatment products. Therapeutics, Incorporated expects its development work will result in multiple Investigational New Drug (IND) filings with the US FDA.

PURE currently has U.S. Environmental Protection Agency Environmental Protection Agency (EPA), independent agency of the U.S. government, with headquarters in Washington, D.C. It was established in 1970 to reduce and control air and water pollution, noise pollution, and radiation and to ensure the safe handling and  (EPA EPA eicosapentaenoic acid.

EPA
abbr.
eicosapentaenoic acid


EPA,
n.pr See acid, eicosapentaenoic.

EPA,
n.
) registration for its 2400-parts per million (ppm) technical grade SDC concentrate (trade name Axenohl(R)) as well as for its Axen(R) and Axen(R)30 hard surface disinfectant products.

Axen30 is distinguished from many of the leading commercial and consumer products because of its superior efficacy combined with its lower toxicity ratings. For example, leading brand household spray disinfectants declare a 10-minute disinfection disinfection,
n the process of destroying pathogenic organisms or rendering them inert.

disinfection, full oral cavity,
n a procedure used to reduce active periodontal disease, usually completed within a certain short time frame.
 time against three widespread disease-causing bacteria: Staph staph
n.
Staphylococcus.



staph adj.
, Pseudomonas Pseudomonas

A genus of gram-negative, nonsporeforming, rod-shaped bacteria. Motile species possess polar flagella. They are strictly aerobic, but some members do respire anaerobically in the presence of nitrate.
 and Salmonella (Staphylococcus aureus ATCC ATCC American Type Culture Collection, see there  6538, Pseudomonas aeruginosa ATCC 15442 and Salmonella choleraesuis ATCC 10708), whereas Axen30 claims a 30-second disinfection time on these same organisms - 20 times faster than the claims made by the leading competitor. Additional claims for Axen30 include a remarkable 24 hour residual kill on standard indicator bacteria, 2 minute kill time on some resistant strains of bacteria, 10 minute kill time on fungi, 30 second kill time on HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  Type I, and 10 minute kill time on other viruses.

Based on the EPA toxicity categorization of antimicrobial products ranging from Category I (high toxicity) down to Category IV, Axen30 is a Category IV antimicrobial for which precautionary labeling statements are normally not required. This compares with Category II warning statements for most leading brands of antimicrobial products.

About PURE Bioscience

PURE Bioscience (PURE) develops and markets technology-based products in the bioscience and water treatment sectors to provide non-toxic solutions to global health challenges. PURE's proprietary high efficacy/low toxicity bioscience technologies, including its silver dihydrogen citrate antimicrobials and Triglycylboride(TM) pesticides, represent innovative advances in diverse markets. PURE is currently America's leader in pharmaceutical water purification with its Fillmaster(R) equipment, and the Company has expanded into residential water treatment with its Nutripure(R) water filtration systems. PURE Bioscience is headquartered in El Cajon, California
This article is about the California city, for the musical instrument see, Cajon. For the valley, see Cajon Pass.


El Cajon (IPA pronunciation in English: [ɛl kə'hoʊn] 
 (San Diego metropolitan area San Diego, California Metropolitan Area:
  • For the metropolitan area see: San Diego County, California
  • For the transnational conurbation, which extends into Tijuana, see: San Diego-Tijuana Metropolitan Area.
) and its common stock is listed on the OTC Bulletin Board OTC Bulletin Board

An electronic quotation listing of the bid and asked prices of OTC stocks that do not meet the requirements to be listed on the NASDAQ stock-listing system.
 under the symbol "PURE." Incorporated in 1992, PURE Bioscience was formerly named Innovative Medical Services.

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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jan 5, 2005
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