The NanoStat™ platform technology enables both topical anti-infective products as well as a broad range of mucosal vaccines. The technology employs high-energy, oil-in-water emulsions that are manufactured at a size of 150-400 nanometers and are stabilized by surfactants.
When applied to the skin, the nanoemulsion nano-size droplets rapidly penetrate through pores and hair shafts to the site of an infection, and physically disrupt the outer membrane of pathogenic organisms by fusing with and killing lipid-containing organisms. The unique aspect of products derived from the company's NanoStat technology is that, unlike currently available therapies, NanoBio’s treatments are selectively toxic to microbes while non-irritating to skin and mucous membranes.
The NanoStat™ technology has shown activity against bacteria (e.g., E. coli, Salmonella), viruses (e.g., HIV, Herpes), fungi (e.g., Candida albicans), and spores (e.g., Anthrax). This spectrum of activity allows for a broad range of anti-infective products. The company's anti-infective products pipeline includes candidates for the treatment of Herpes Labialis (cold sores), Onychomycosis (nail fungus), Tinea capitis, infections resultant from severe burns, methicillin resistant Staphylococcus aureus (MRSA), genital herpes, Molluscum contagiosum, and an inhaled treatment for bacterial infections associated with
. In addition, future research activities at the company will be directed towards potential product candidates for treating vaginitis and other infections.
The principal advantages of NanoStat therapies include:
- A topical application that has shown efficacy equal to, or superior to, systemic therapies;
- Broad spectrum of activity, shown to be effective against bacteria, enveloped viruses, fungi, spores and protozoa;
- Safety proven in Phase I and Phase II clinical trials in over 900 patients, in that NanoStat drugs are non-irritating to the skin and mucous membranes, they are not systemically absorbed;
- NanoStat therapies have a broad therapeutic index as confirmed in multiple animal studies and in NanoBio’s clinical trials;
- Limited potential for drug resistance to develop, given the unique mechanism of action which involves a physical process as opposed to a chemical synthesis.
The NanoStat technology also enables a platform of nanoemulsion based mucosal vaccines. When either whole virus or a recombinant protein antigen is simply mixed with nanoemulsion and placed on the naso-pharynx, the nanoemulsion serves as a potent adjuvant, producing both mucosal immunity and systemic immune response. Virtually any bacterial or viral disease that results in a human immune response is a potential candidate for the development of a NanoStat mucosal vaccine. Active development programs are underway for RSV, Influenza, Hepatitis B, and other indications.