GEL FOR THE TREATMENT OF BACTERIAL VAGINOSIS
1st Topical Anti-Infectious & pH Regulating Medical Device for the treatment of Genital Herpes and Vaginal Infections
HSV-2 & Vaginal Infection
Physiopathology: Nearly 70% of women harbor the HSV-2 herpes virus which remains dormant in the nerve cells until it gets periodically activated, travelling along the nerves and reaching the vaginal mucosa, causing inflammation and the occasional formation of papules. Clinical signs are mostly related to overgrowth or imbalance in the native microflora, secondary bacterial infection, changes in pH (more alkaline), and mild but chronic manifestations consisting in, often foul-smelling, vaginal discharge, & irritation or burning during urination. Secondary infection causes cellular damage, inflammation, & pain & itching.
Ideal Treatment Approach:
Neutralize free virus particles to stop and prevent further virus multiplication, remove bacteria & other contaminants, stop inflammation, & normalize vaginal pH simultaneously. A mono-target treatment will not be effective.
Currently Available Treatments:
- Topical Anti-Virals: none
- Symptomatic: local antiseptics, anti-inflammatory, pH regulators → recovery takes a very long time as they are mono-target.
VITROBIO‘s Completely NEW Therapeutic Approach: Protein Hypothesis to block HSV & inflammation: HSV2 is an enveloped Virus with several Glycoproteins (GPs) on its surface (gB, gA, gC) which allow virus entry into the host cells. Vitrobio postulated that these virus proteins could be blocked & new virus infection could be stopped using specific virus protein antagonist polymers (Ref: Hypothesis – Shrivastava et al: Int. J. Virology, 2011). Secondly, as vaginal mucosa inflammation is maintained due to the presence of inflammatory cytokines (TNF, TGF, Interleukins), these proteins could also be blocked using specific anti-cytokine polymers. Employing this technology, specific polymers were identified to neutralize up to 98% HSV & between 20-90% inflammatory proteins within a few minutes (see figs. below).
These polymers were incorporated into a glycerol-based viscous liquid, 18 times more osmotically active than sea water yet NON-IRRITANT (VB-Gy – International patent 1997: PCT/FR99/01340). Further, VB-Gy was rendered filmogen and long-acting (N° PCT/EP2013/061835). Vb-Gy instantly forms a film on the vaginal mucosa, creates a strong outward flow of hypotonic liquid which helps detaching instantly all the microbial & other contaminants. Being acidic, VB-Gy equally normalizes vaginal pH. These mechanical effects are nearly instant.
Product presentation: 30 mL Spray to be applied 3-4 times a day or more if necessary, until complete recovery.
Regulatory Status: Being a filmogen liquid bandage, Class I Medical Device in Europe.
Product Presentation: 3x10mL or 1x50ml tube. Class IIa medical device for topical application. Totally safe, can be used during pregnancy.
Clinical Efficacy: Full trial published in J Pharmaceutical & Scientific Innovation 2(1), Jan-Feb 2013, 47-51; e-ISSN: 2277-4572.
Marketing Status: Ready to launch (Registered as Medical Device in Europe, Australia)