SAN DIEGO -- PURE Bioscience announces 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 Food and Drug Administration (FDA) over the next 24 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.
The companies anticipate IND filings for bacterial vaginosis, a lead dermatophytoses indication (athlete's foot/nail fungus) and acne in 2007.
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 12 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. 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.
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.
Source: PURE Bioscience