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, itching, irritation or burning during urination.
Ideal Treatment Approach:
Neutralize free virus particles to stop and prevent further virus multiplication, remove bacteria & other contaminants, normalize vaginal pH.
Currently Available Treatments:
• Topical Anti-Virals: none
• Symptomatic: local antiseptics, pH regulators → recovery takes a very long time
VITROBIO‘s Completely NEW Therapeutic Approach: Protein Hypothesis as Topical Anti-Viral, Anti-bacterial & pH-regulating.
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 or natural tannins (Ref: Hypothesis – Shrivastava et al: Int. J. Virology, 2011). Similarly, bacterial infection can also be stopped by neutralizing bacterial polysaccharides with polymers capable of binding with macromolecules. After 17 years of R&D, Vitrobio identified specific polymers which can bind with selected targets & neutralize the infection (Patent PCT/EP2010/050236). These polymers were then incorporated into a patented glycerol-based filmogen viscous solution, glycerol being commonly used as pharmaceutical excipient & 18 times more osmotically active than Sea Water yet NON-IRRITANT (International patents: PCT/FR99/01340) capable of instantly attracting hypotonic fluid from the inner surface, dislodging and flushing all the contaminants from the vaginal cavity. HG-VB is the 1st, topical Anti-Infectious & pH Regulating for the treatment of Genital Herpes and Vaginal Infections.
Product Presentation: 3x10mL tubes
Directions: Topical application, deep into the vagina, of the contents of 1 tube per day for 3 days. Repeat if required. For outer lesions: a few drops on the lesion, 3 to 4 times a day until complete recovery.
Regulatory Status: Due to the mechanical topical filmogen activity without any pharmacological, biological, metabolic or immunological interaction with the cellular structure: Class IIa Medical Device in Europe.
Contraindications: Not to be used in pre-pubertal pediatric population (under 13 years of age).
Side Effects: None. Can be used during pregnancy or lactation.
Clinical Efficacy: Full trial published in J Pharmaceutical & Scientific Innovation 2(1), Jan-Feb 2013, 47-51; e-ISSN: 2277-4572.