Vical Incorporated (Nasdaq:VICL) announced the completion of enrollment in a Phase 1/2 trial of its vaccine for herpes simplex virus type 2. (1)

ROCHESTER, NEW YORK, UNITED STATES, February 13, 2015 /EINPresswire.com/ --

“Infected with the herpes virus (HSV-1 or HSV-2)? The CBCD recommends taking Novirin.” - Greg Bennett, CBCD

A phase 1/2 trial of Vical Incorporated’s therapeutic vaccine for herpes simplex virus type 2 (HSV-2) recently completed enrollment of study participants. “The randomized, double-blind, placebo-controlled trial will evaluate safety, tolerability and efficacy of two vaccine candidates (one encoding glycoprotein D alone and the other in combination with UL46). The study is powered to show at least a 30% decrease in the viral shedding rate following 3 doses of vaccine. A total of 165 otherwise healthy HSV-2- infected patients aged 18 to 50 years were enrolled across seven U.S. trial sites. The Company expects to release efficacy data by the middle of 2015.” (1) Dr. Larry Smith, Vical's Vice President of Vaccine Research said that “The completion of the enrollment of this trial represents an important milestone for Vical. We are now following these subjects and are pleased with the speed of enrollment at our clinical trial sites. This Phase 1/2 trial is a vital step towards developing a product that is safe, and reduces viral shedding and genital herpes lesions.” Company officials are hopeful that the vaccine candidates will reduce shedding of the herpes virus in infected individuals by up to 30%.

It is important to understand why viral shedding must be reduced. When the herpes virus sheds, it is easier to transmit the virus from one person to another. “Once replication has been completed and the host cell is exhausted of all resources in making viral progeny, the viruses may begin to leave the cell by several methods.” (See ntroduction to Modern Virology, 6th edition, from 2007) (2) Stopping the herpes virus from shedding has proven difficult, however.

Vical officials noted that “High unmet medical needs exist for new treatments because existing treatments of acyclovir-based antivirals can temporarily reduce but not eliminate genital herpes, viral shedding, and transmission; these drugs have not appreciably impacted HSV-2 seroprevalence rates despite over 30 years of usage.” (See StockHouse.com from October 8, 2014) (3) In other words, traditional anti-herpes medications have not lowered the HSV infection rate in over 30 years, and company officials are hopeful that their vaccines will change this reality.

Developing an effective, therapeutic vaccine against the genital herpes virus (HSV-2) and gaining FDA approval takes time, and there is no guarantee of success. Until Vical’s anti-herpes vaccines are proven safe and effective, and gain FDA approval, the CBCD recommends that infected individuals take Novirin, which is an HSV-2 remedy backed by clinical studies.

Click to learn more about herpes symptoms.

The formula of Novirin was tested by Hanan Polansky and Edan Itzkovitz from the CBCD in two clinical studies that followed FDA guidelines. The studies showed that the Novirin formula is effective against the herpes simplex family of viruses, which includes VZV. The clinical studies were published in the peer reviewed, medical journal Pharmacology & Pharmacy, the first, in a special edition on Advances in Antiviral Drugs. Study authors wrote that, “individuals infected with the (HSV-1) … reported a safe decrease in their symptoms following treatment…” (4) The study authors also wrote that, “we observed a statistically significant decrease in the severity, duration, and frequency of symptoms.” (4)

Novirin can be ordered online through the product website, here: http://www.novirin.com

Novirin is a natural antiviral dietary supplement. Its formula contains five natural ingredients: Selenium, Camellia Sinesis Extract, Quercetin, Cinnamomum Extract, and Licorice Extract. The first ingredient is a trace element, and the other four are plant extracts. Each ingredient and its dose was chosen through a scientific approach. Scientists at polyDNA, the company that invented and patented the formula, scanned thousands of scientific and medical papers published in various medical and scientific journals, and identified the safest and most effective natural ingredients against latent viruses. To date, Novirin is the only natural antiviral product on the market with published clinical studies that support its claims.

Dr. Anna Wald said that “a therapeutic vaccine is an important and promising new approach for reducing viral shedding because of its potential ability to bolster the immune system to control HSV-2 … A therapeutic vaccine option has the potential to enhance quality of life by freeing patients from daily, lifelong antiviral drug usage. I look forward to the completion of the trial and reviewing the results in 2015.” (1) Dr. Wald is a Professor of Allergy and Infectious Diseases at the University of Washington and Fred Hutchinson Cancer Research Center and the Principal Investigator of the Phase 1/2 trial.

“Approximately one out of every six individuals aged 15 to 49 years worldwide is chronically infected with HSV-2. HSV-2 infections are persistent and can result in genital lesions, as well as periodic virus shedding placing sexual partners at risk of infection. The presence of HSV-2 genital lesions also significantly increases the risk of acquiring HIV-1 from HIV-infected sexual partners. There is no FDA approved vaccine for HSV-2.” (1)

Vical has a proprietary vaccine delivery system. That is, its methods include using DNA delivery technology “in which the expressed protein is an immunogen” (a substance that the immune system recognizes and attacks). (1)

What treatments are currently available for those infected with the herpes virus?

“Two types of antiviral treatments against HSV are available: topical and oral. The treatments include penciclovir, acyclovir, famciclovir, and valaciclovir. However, their effectiveness is limited. For instance, a meta-analysis of five placebo-controlled and two dose comparison studies evaluated the effect of aciclovir, famciclovir or valaciclovir on symptoms. The meta-analysis showed that oral antiviral therapy decreases the duration and the associated pain of an outbreak by merely one day.” (4) There is also the natural supplement Novirin, which has a formula that was designed to help the immune system target the herpes virus when it is in a latent form.

In light of the fact that there are no vaccines against the herpes virus currently on the market, the CBCD recommends that HSV infected individuals take Novirin.

Click to learn more about Novirin and HSV.

References:

(1) Nasdaq.com - "Vical Completes Enrollment in Its Therapeutic HSV-2 Vaccine Clinical Trial." Published December 11, 2014.
http://www.nasdaq.com/press-release/vical-completes-enrollment-in-its-therapeutic-hsv2-vaccine-clinical-trial-20141211-00157

(2) N.J. Dimmock et al. "Introduction to Modern Virology, 6th edition." Blackwell Publishing, 2007.

(3) stockhouse.com - Vical Granted Six U.S. Patents for HSV-2 Vaccines. Published October 8, 2014
http://www.stockhouse.com/news/press-releases/2014/10/08/vical-granted-six-u-s-patents-for-hsv-2-vaccines

(4) Polansky, H., Itzkovitz, E. Gene-Eden-VIR Is Antiviral: Results of a Post Marketing Clinical Study. Published on August 12, 2013. http://www.scirp.org/journal/PaperInformation.aspx?PaperID=36101#.VH2qQNKUf90

Hanan Polansky
Lilac Corp.
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