AuRx, Inc., Announces Publication Of The Successful Results Of The Clinical Evaluation Of Its Therapeutic Vaccine For Genital Herpes
BALTIMORE, Oct. 11 /PRNewswire/ -- The Mexican clinical team evaluating the AuRx therapeutic vaccine for genital herpes has published the initial results of a safety evaluation for the lowest dose in a Phase I/II trial for treatment of genital herpes in the October issue of Cutis. There were no treatment related adverse events in the trial and the side effects were similar to that of a sugar pill. Dr. Gerardo Casanova, the lead investigator said, "Of most importance, is that we now potentially have available a therapeutic vaccine that will avoid many complications for the patients, and in particular the serious perinatal risks."
In the first finding of its kind in the history of the treatment of genital herpes, the AuRx therapeutic vaccine reduced the number of episodes three fold (P less than .001) versus the previous year. In addition, recurrent HSV-2 episodes were completely prevented in 37.5% of vaccinated patients as opposed to the patients given placebo, all of whom had episodes during the trial period. These patients had previously had 5-24 outbreaks per year. In statistically significant results, vaccinated patients had 50% fewer recurrences and 45% fewer illness days (P=.028) than the placebo. A reduced severity of the herpetic episodes in vaccinated patients was observed as lesions were 4.8 times more prevalent in untreated patients, pain was 2.9 times more prevalent in untreated patients and itching was 3.7 times more prevalent in untreated patients.
The trial continues by tracking for clinical outbreaks over a two-year period. AuRx plans to run additional studies in larger groups with higher dose levels and additional vaccinations. In guinea pigs which were first infected with genital herpes and then given the same dose schedule used in the human clinical trial, 70% of the animals had no recurrences. Higher doses and a different dose schedule in animals resulted in over 90% prevention of recurrences.
Over 50 million Americans are infected with genital herpes. The incidence of genital herpes is rapidly increasing world wide and is projected to affect 39% of women and 49% of men aged 15 to 39 in the US by 2025. At present there is no convenient method to prevent recurrences of these painful lesions which are often transmitted to sexual partners. Treatment of herpes with currently available drugs only slightly reduces the time the patient has lesions. It also requires reliably taking medication on a daily basis since failure to do so usually results in an episode. Over the last three decades, pharmaceutical companies have failed in their attempts to develop a herpes vaccine as none have achieved statistical significance in trials nor have any shown therapeutic effects.
AuRx, Inc., is a privately held company developing methods for treatment of recurrent and long-lasting viral disease.
I also posted this information on other message boards for people with herpes after I talked to Gary Carlton who is the President of AuRx. God bless you all.
Not sure if they would work for HSV-1, but I am assuming so or at the very worse it would only take them some slight adjustments to the existing vaccine.
OK, I just talked to Gary Carlton at AuRx and he was a really nice gentlemen and very happy about the results. He stated that the vaccine really works and out of all the people that were tested with the vaccine only four people had any vesicles / lesions reappear, which were very mild compared to the patients continuos multiple OB's prior to vaccination. This success was with the lowest/minimal dose, which was very encouraging. He went on to state that what they are basically doing now is:
1. Following patients who have been vaccinated to see how long the vaccine works or stays in an individuals body.
-AND-
2. Testing individuals with a different dosage (I am assuming higher dosage) to see if recurrences ever happen again.
He stated that the vaccine was sort of like a Tetanus shot were an individual might have to get it once every 5 or 10 years. The Mexican Ministry of Health wants AuRx to follow people who have been vaccinated for two years and follow their progress.
As I mentioned in my previous post I thought/believed the vaccine would be available in Mexico or some other country way before it would be available here in the US and Mr. Carlton confirmed my belief. He stated that the vaccine should be available in Mexico and South America probably within a couple of years and then Europe, and after that the United States. He stated that it should be available in the US in 4 or 5 years. This was his "guesstimate"
As he stated so aptly to me that this is the reason for them holding there clinical trials in Mexico because the process is much shorter than holding clinical trials in the US.
He stated that the best thing we can do and this is IMPORTANT.. Is to call our local newspapers, magazines, etc. and tell them about the success of the clinical trial so they can get the word out via their publications or whatever. This in turn will interest investors and the rest is history. Once this happens it will all start to roll down hill and the vaccine will be available here in the US!! Like I've stated before.. Once these trials are proven I will not hesitate to go to Mexico. I am not going to wait for the FDA to drag their feet, but this will not stop me from trying to help it getting approved here quicker in the US, since I would like to see as many people helped out as possible with this infection.
With all this being said..... I hope all of us call our local newspapers and do whatever we can do to get the word out.
This is just my personal opinion, but I have a feeling that if AuRx doesn't partner up with a major pharm company the FDA will either
1. Take forever to approve the use of this vaccine
-OR-
2. Not approve it at all no matter how successful it is!! The reason for this is because they are so intertwined with the big pharm companies. They will loose billions of dollars on suppressive therapies and therefore make up some story that the efficacy was not proved here in the US therefore they will not approve it. REMEMBER PEOPLE the bottom line is money.. This is very sad to say, but its the truth.
May God bless all of you and may God bless AuRx and this vaccine. Please contact your local papers and get the word out.
Originally posted by Hwklatino: This is amazing!! I posted this great news and nobody has replied or seems to care!! WOW!! I guess I'm just shocked! OH WELL, God bless you all!!
First of all, there aren't exactly hoards of people who frequent this board. Second, I'm sceptical because I hadn't heard of a study of this nature being done, and have sent a request to a medical site to check out your claim. Third, what you have written comes across like SPAM which I normally don't reply to, no matter where I find it.
First, I know a lot of people probably don't visit this site, but I thought I would at least get a response or something because I know a lot of people including myself suffer from this infection and this was the best news to date unless someone knows of another medication with the same results.
Second, I can understand why you might be skeptical because you haven't heard of this study/clinical trial. I am glad you sent a request to a medical site you trust to check out my claim about the AuRx clinical trials. You will see that I'm telling the truth!
Third, Don't judge a book by its cover!! I have no affiliation whatsoever with AuRx! I was just excited about the news of a therapuetic vaccine. I'm sorry it came across like SPAM, but coming across like SPAM is the exact opposite of what I attended to do. All I did was post the LEGITIMATE press release from AuRx. My second post after I posted the press release was to inform people of what Gary Carlton told me after talking to him. Gary Carlton is the President of AuRx.
One of the head researchers (And I am assuming this is where the company AuRx gets its name from)is Dr. Laure Aurelian. She is Professor of Pharmacology and Experimental Therapeutics and Microbiology and Immunology at the University of Maryland. She received her Ph.D from John Hopkins University. She deals with Molecular biology and immunology of herpesvirus infections; oncogenes and vaccine development; antisense gene regulation. If you don't believe me you can look it up yourself or better yet wait for your reliable medical site you trust to confirm what I am saying!
Like I stated before. I was very excited about the news and just wanted to inform people.