SDC antimicrobial effective against T. mentagrophytes in preclinical tests

Pure Bioscience announces that based on encouraging preclinical data it has granted two product-specific licenses to pharmaceutical development partner FTA Bioscience for development of a silver dihydrogen citrate (SDC)-based treatment for tinea unguium, also referred to as onychomycosis (nail fungus), as well as for tinea pedis (athlete’s foot).

In a study directed by Mahmoud A Ghannoum, PhD, EMBA, Pure’s patented SDC was evaluated in the topical treatment of Trichophyton mentagrophytes dermatophytosis using the same guinea pig model previously developed and used in the preclinical evaluation of current FDA-approved antifungal agents for the treatment of onychomycosis.

Two groups of animals were infected with T. mentagrophytes; one group was treated with SDC twice daily for seven days, and the other served as an untreated control.

The treatment group showed significant mycological and clinical improvement when compared with the control. Ghannoum is the chief scientific officer of FTA and professor of dermatology at University Hospital as well as director for the Center for Medical Mycology and co-director of the Skin Diseases Research Center at Case Western Reserve University.

“Dermatophytes and Candida are major causes of superficial fungal infections of the feet which, if left untreated, can lead to progressive deterioration of the infected area that is often painful and can negatively impact the quality of life,” stated Anthony J Balsamo Sr, MD, F.A.C.S., Geisinger Specialty Clinics, Orthopedics and founder and CEO of FTA.

“Current treatments are often ineffective for the approximately 35 million people with nail fungus and the 27 million people suffering from athlete’s foot in the United States. We see a significant market opportunity to develop new SDC-based topical antifungal agents as an alternative to oral antifugals. Oral medicines are not ideal because of their limited effectiveness, side effects and the potential drug interactions presented when used concurrently with other medicines. Therefore, an effective topical treatment would be preferred and, furthermore, its continued use may help prevent recurrence of the infection. We believe SDC could act not only as an effective cure but also as an effective preventative treatment.”

Ghannoum added, “We have observed exciting results from our preclinical work with SDC on various dermatophytes and Candida strains, including the T. mentagrophytes animal study. We look forward to continuing our research to establish SDC as an effective antimicrobial agent for other dermatological conditions as well as for wound care, and we expect to file Investigational New Drug (IND) Applications for multiple products and indications in 2011.”

Pure’s president and CEO, Michael L Krall, said, “The team at FTA has invested significant time and resources into formulation development of SDC into topical fungal products, and we are certainly pleased with the results. In our pharmaceutical partnering model, completion of a pre-defined preclinical proof-of-concept study is the final precursor to the issuance of any product specific license. Therefore, upon review and acceptance of this proof-of-concept study by FTA, we promptly issued the license to FTA to proceed with the IND process. We look forward to providing updates as clinical trials are completed and milestones are achieved.”