Launched or under launch (2013-2015): Australia, Austria, Canada, Chile, Colombia, Denmark,Egypt, Israel, Jordan, Malaysia, Middle East, Montenegro, New Zealand, Romania, Serbia, South Africa, Spain, Tunisia.
6mL (tube) Class IIa Medical Device for the treatment of open Labial Herpes lesions (Official Indication)
LABIAL HERPES (Herpes Simplex Labialis)
Physiopathology: After initial infection, HSV1 ascends nerve axons & remains latent in the ganglia, until it gets activated by a trigger & migrates to the skin and mucosa surface. A vesicle develops where the virus multiplies. The open lesion then sheds large amounts of free virus particles which infect new host cells, spreading the infection & lesions, resulting in pain & burning sensation.
Most adults have been exposed to HSV1 & 20-40% of them will develop recurrent Cold Sores.
Ideal Treatment Approach: Neutralize free virus particles to stop and prevent further virus multiplication, remove other contaminants, and promote rapid lesion healing.
Currently Available Treatments:
• Topical Anti-Viral: none
• Intracellular Virus inhibitors: Acyclovirs such as Zovirax, etc… → Good as preventive but not effective at all on free virus.
• Symptomatic: topical anesthetics, antiseptics, analgesics.
None of these treatments is capable of neutralizing the virus & stopping further infection, or stimulating instant lesion healing so as to minimize pain & irritation.
VITROBIO‘s Completely NEW Therapeutic Approach: Protein Hypothesis for Anti-Viral Drugs.
HSV1 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 & PCT/EP2013/061835). The hypertonic solution film attracts hypotonic fluids from the lesion surface and dislodges all contaminants, reduces pain & irritation and promotes a clean, favorable environment conducive to accelerated lesion healing. Due to instant the mechanical effects consisting in neutralizing the infection, cleaning & protecting the sore, lesion healing & symptomatic relief are very fast. Herpecilin is the 1st, topical, safe, new generation of cold sore treatment.
Product Presentation: 6mL tube
Posology: Apply 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.
Side Effects: None
Clinical Efficacy: Full trial published in Int J Biological & Pharmaceutical Res. 2013; 4(4): 242-249; e-ISSN: 0976-3651.
Conclusion: 1st topical Anti-Viral & Healing Gel for Cold Sores