Rational Vaccines, a biotechnology company at the forefront of herpes research, announced results from a Phase I Clinical Trial of their potentially revolutionary TheravaxHSV-2 vaccine. Although still in the early months following the completion of the Phase I Trial, the human data collected to date positions the live-attenuated TheravaxHSV-2 vaccine to be one of the most effective therapeutic vaccines ever created for individuals suffering with herpes simplex virus 1 and 2 (HSV-1 or HSV-2), and suggests a “functional cure” for both HSV-1 and HSV-2 may be on the horizon.
The study met its primary goal of establishing the safety and tolerability of the live-attenuated TheravaxHSV-2 vaccine in patients who suffer with recurrent genital herpes caused by HSV-1 or HSV-2. This early-phase trial revealed TheravaxHSV-2 elicited stunning reductions in herpes symptoms among trial participants. Specifically, 17 of 17 participants who received the 3-shot vaccination series indicated the live TheravaxHSV-2 vaccine was more effective in reducing their genital herpes symptoms than antiviral drugs. On average, participants reported a 3.2 fold reduction in their number of herpes-symptomatic days per month relative to years of experience taking antiviral drugs. The trial was led by head researcher, inventor and Chief Science Officer of Rational Vaccines William Halford, PhD., who has been performing laboratory research and publishing on the safety and efficacy of the TheravaxHSV-2 vaccine in pre-clinical studies for more than a decade.
“Doctors have been trying to manage genital herpes for 30 years with acyclovir-like antiviral drugs, and the approach has not stopped the spread of herpes,” says Dr. Halford. “Over one million people per week continue to be newly infected with HSV-1 or HSV-2. It is time to offer herpes sufferers a 21st century solution with the potential to not only better treat herpes, but to simply stop the spread of the disease.”
In the United States, one out of six people aged 14 to 49 have genital herpes. Aside from genital herpes, HSV-1 is a major cause of blindness and life threatening encephalitis – or inflammation of the brain. Neonatal herpes, a life-threatening complication that occurs when babies contract HSV-1 or HSV-2 from their mothers during childbirth, is also a major concern. The World Health Organization has called for better herpes prevention strategies, as people with genital herpes are three times more likely to contract HIV/AIDS.
Currently the only FDA-approved treatment for herpes is antiviral drugs, and the results of the Phase I TheravaxHSV-2 vaccine trial suggests that this therapeutic HSV-2 vaccine may offer sufferers with a more effective treatment option. Rational Vaccines has licensed the patents upon which the live TheravaxHSV-2 vaccine is based and has also licensed a superior antibody test called the “HSV ABVIC” test which measures HSV Antibody Binding to Virus-Infected Cells.
“This is a very exciting time when it comes to medical innovations. Dr. Halford has created a safe and effective vaccine. Eradicating the HSV pandemic in our lifetime is within our grasp,” says Agustin Fernandez III, CEO of Rational Vaccines. “Dr. Halford’s research and our company’s recent clinical trial have opened the door to a better world where herpes no longer has to be suffered in silence, but can be treated and prevented.”
Rational Vaccines is continuing to monitor the HSV-2 symptoms in clinical trial participants and is taking further steps to advance its live TheravaxHSV-2 vaccine from the laboratory to the clinics. For more information, please visit www.rationalvaccines.com.
To view the full press release, click here.
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Filed Under: Drug Discovery