NanoBio has developed an antigen free nanoemulsion that is a non-toxic antiviral that inactivates influenza virus by directly fusing with and disrupting the virus membrane. Animal studies have documented that when applied to the nares, the nanoemulsion is able to prevent influenza infection by killing viruses before they can infect.  In these studies 80% of the animals pretreated with saline alone died from influenza pneumonia.  Seventy percent of the antigen free nanoemulsion protected animals survived the challenge (Fig 1).

Extensive human studies have shown safety when applied to the skin daily for 9 months to treat infections of the skin. Recent preliminary studies have indicated the emulsion is safe when placed in the nares of humans. The product could provide a means to prevent infection and reduce transmission of the virus between humans regardless of serotype or resistance to traditional anti-viral drugs.

Potential High Value OTC Product:

The concept of an antigen free safe OTC preventive for influenza has significant potential as a prophylaxis for influenza that would be used to prevent pandemic or seasonal flu infections when there is a high risk of exposure.  High risk events could include air travel, visits to the pediatrician’s office, hospital or any situation where groups of people congregate.  Other examples include trips to a crowded shopping mall, the gym or a sports event.  The product would be applied by the consumer as a nasal spray prior to the time of anticipated exposure. 

Status / Development Plan:

Formulation development is complete.  Much of the product safety, toxicity and stability work is underway and integrated with the active NanoBio influenza vaccine program. Experience with other nanoemulsions indicates that manufacturing scale-up will be a straight forward process. Formulation development is complete.  Much of the product safety, toxicity and stability work is underway and integrated with the active NanoBio influenza vaccine program.  Experience with other nanoemulsions indicates that manufacturing scale-up will be a straight forward process.  

Installation of a product development and commercialization arrangement with an appropriate pharmacutical partner represents the next step in the development program for this product.

Fig. 1:  Murine Antigen-free Influenza Prevention Experiment

Study Design:

• Active arm animals protected with nanoemulsion nebulized into their nares
• Control arm animals pretreated with nasal saline
• 90 minutes later, a 80X lethal dose was nebulized into chamber
• Mice were followed for evidence of influenza pneumonitis
• Repeated on four different groups of animals

Results:

• Eighty percent of animals pretreated with saline alone died from influenza pneumonia (red line).
• Seventy percent of the antigen free emulsion protected animals survived the lethal challenge.

Conclusions: 

• Pretreatment of nares of mice with an antigen free nanoemulsion prevented influenza pneumonitis after aerosolized highly lethal dose virus challenge
• Effect was present at two hours
• No toxicity from emulsion was observed (10-50 fold therapeutic index)

Publications

Donovan B, Reuter J, Cao Z, Myc A, Johnson K, Baker JR Jr (1999) Prevention of murine influenza A virus pneumonitis by surfactant nanoemulsions.

Antiviral Chemistry & Chemotherapy 11:41-49. Download PDF file of this article (2600K)