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BIO TECHNOLOGY

The RELEEV range of Products is based on the proprietary botanical formulation Viracea 1 and Viracea 2 which contain the OTC antimicrobial antiseptic Benzalkonium chloride.

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One of the traditional approaches to stopping viral infections is vaccination. This has proved successful against smallpox, polio, mumps and measles, to name a few, but vaccination only works prior to infection and in some cases, it is not effective at all.
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HIV and herpes are retro-viruses. Retroviridae is a family of enveloped viruses that replicate in a host cell through the process of reverse transcription. A retrovirus is a single-stranded positive-sense RNA virus with a DNA intermediate and, as an obligate parasite, targets a host cell. Once inside the host cell cytoplasm, the virus uses its own reverse transcriptase enzyme to produce DNA from its RNA genome, the reverse of the usual pattern, thus retro (backwards). This new DNA is then incorporated into the host cell genome by an integrase enzyme, at which point the retroviral DNA is referred to as a provirus. The host cell then treats the viral DNA as part of its own genome, translating and transcribing the viral genes along with the cell’s own genes, producing the proteins required to assemble new copies of the virus. It is difficult to detect the virus until it has infected the host. At that point, the infection will persist indefinitely. To the lay person, they infect the host and then hide waiting to break out into full blown infection. In the case of HIV the result is AIDS which is potentially fatal. In the case of herpes, the outbreak produces very painful lesions called cold sores or fever blisters on the lips and mouth or genital herpes in the intimate regions, or herpes infection of fingers called whitlow, or herpes keratitis of the eye. Clinical trials prove that RELEEV (Viracea) is effective at arresting an outbreak of the herpes virus when the virus becomes active.
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It is believed that Viracea denatures the lipid protein shell surrounding the viral RNA. Without the lipid shell the virus cannot attach to the healthy host cell to invade and replicate. Although it is not possible to eliminate a retro-virus from the host once acquired, RELEEV Treatments can heal an outbreak once activated and after the infection becomes full blown.

VIRACEA

Tracy L Hartman, Karen M Watcon, Lu Yang, Meryl J Squires, Robert W Buckheit Jr. ImQuest BioSciences, Inc. Frederick, MD

Echinacea is a well studied herb noted for stimulating the human immune system. There is evidence that Echinacea has the potential to treat a broad range of infectious diseases. Viracea, a proprietary extraction and formulation of Echinacea is presently marketed as RELEEV™, a commercial OTC product for the treatment of cold sores. Preclinical data indicates this product is active against HSV-1 and HSV-2. We have evaluated the broad based anti-infective properties of these products, including RELEEV and Viracea 2.4 an unfractionated product compromised of the aerial parts of Echinacea pupurea and Commiphoro myrrha. RELEEV and Viracea 2.4 were highly active against HIV-1, HIV-2, HSV-2, BVDV and the HCV replicon 122106. Actively against laboratory-derived strains of HIV was detected at greater than 1:30,000 dilutions though lesser levels of activity were found against clinical strains of HIV-1 and HIV-2, suggesting a mode of action involving entry inhibition. MAGI cell-based assays confirmed the ability of the natural product to inhibit HIV entry. Similar levels of activity were detected against HSV-1HF and HSV-2MS in VERO cells, HBV in HepG2.2.15 cells BVDVNADL in MDBK cells, and against the HCV replicon in Huh-7 cells.

In the case of herpes, the virus can be transmitted even though individuals have no idea they are infected (viral shedding). In clinical studies and in-vitro research, Viracea® demonstrated a highly effective safe and fast-acting treatment to speed the healing of herpes lesions with no reported toxicity.

In laboratory tests, respiratory syncytial virus (RSV) was also inhibited, though antiviral activity was not observed against Influenza A or B . Although the mechanism of action of the product against HIV and herpesviruses seems to involve cell surface effect, activity of the product against HBV and in the HCV replicon assay suggests an intracellular mode of action. The range of action of the material also extends to bacteria, where both products were inhibitory in MIC assays to Gram positive and Gram negative bacteria (S.aureus and E.coli) Thus, the anti-infective attributes render Echinacea-derived products interesting for continued researchas a treatment for infectious disease. The potent activity against HIV, HSV, and HCV suggest the potential for the development of an effective topical microbicide. A product is being developed for that use. Currently, bioassay-guided fractionation is being performed to define the active molecules responsible for the the observed anti-infective activity.