An Open Letter

Many of you who are infected with HSV-2 wonder why AuRx has had so much difficulty in raising funds. You are not alone, we wonder too. We have approached every company in the world who might remotely be interested in our technology and they have all decided not to move forward in collaboration on the program for technical reasons. They cannot doubt the accuracy of the data produced because it has been published in peer reviewed journals by scientists who are respected in their fields. Some have given reasons for their lack of interest. These include in the order of highest usage first:

1. �________ is not interested in the area of herpes�;
2. �_________ is not interested in a live recombinant program�;
3. �It is outside our area of expertise�.
4. �The price will not be sufficient because patients will pay for little pills every day but not for two or three shots�;
5. �There are not enough patients who will take this treatment�;

AuRx believes that reasons 1 and 3 represent a way to avoid an evaluation on the part of major pharmaceutical companies � �No one ever gets fired for saying no to a new idea.� (The New Yorker Feb 16, 23, 2004, �The Pipeline Problem�) Reasons 2, 4 and 5 are answered below.

The cost of suppressive therapy with Valtrex, 500 mg per day, for one year at an online pharmacy is $1,956 (Feb, 2004). There are 60 million people in the US with HSV-2. The rate of infection is 1.6 million persons per year and the 1994 estimate for persons currently infected was 45 million. However, only 10% of those infected know they have genital herpes so that means that only 6 million people in the US know they are infected with genital herpes. Now you know why a continuing treatment with the current drugs is a desirable business for a pharmaceutical company.

The Wall Street Journal (Feb 9, 2004, p A26) ran an opinion piece entitled �When Judges Play Doctor� in which the history of lawsuits against pharmaceutical companies was recounted. Dr. Offit included thimerosal, polio vaccine, Bendectin, Nonoxynol-9 and silicone for breast implants in the piece, detailing the lack of scientific rationale in the lawsuits for each. In spite of this lack of evidence, juries awarded billions of dollars to the plaintiffs. As a result of this, pharmaceutical companies believe that they must go far beyond what the FDA , CDC and EPA may presently know looking into the future for two generations or more. What does this have to do with the AuRx therapy? A live recombinant may theoretically recombine to form the original virus. If the AuRx therapy were used as a vaccine � to prevent someone from getting genital herpes � and there was a mistake in the manufacture or the recombinant came into contact with the herpes virus, there would be a possibility that such a person could get genital herpes from the vaccine. But AuRx, by research and therapy, has moved past that point. AuRx is not going to commercialize a preventive vaccine but rather a therapy. The AuRx therapy is intended to be used in only those persons who already have the disease � to prevent further symptoms and recurrences. Anyone who is infected with HSV-2 will never be completely rid of the virus. HSV-2 will continue to remain latent (not growing) in the neurons.

A patient receiving a shot of a weakened HSV-2 virus would only add that virus to their already existing strain of HSV virus present � not another disease. A fair number of cases of people being infected with multiple HSV-2 strains have already been reported in the medical literature. Many of you are aware of this. People who meet others at Herpes Social Groups do not have worse herpes when they are exposed to a different strain. We also know from our research that the AuRx weakened HSV-2 strain does not grow in mice, guinea pigs, or immunodeficient mice. As a result, we conclude that the AuRx recombinant does not grow in animals!

The acquisition of herpes would not be a problem if the AuRx therapy, when approved, was used only for the intended purpose of preventing recurrences. But can that be assured? There might be persons who are infected with HSV-1 who want to try the therapy � for instance in cases where herpes may lead to blindness. And there might be people who wanted to try to get rid of severe cases of facial HSV-1. The animal data indicate that this might be possible, however, many trials would have to be run before this would be allowed. Unfortunately, once something leaves the Company�s hands, it cannot be controlled to the degree that these companies are willing to take the risk of spending the large amount of money necessary to gain approval for sale. Especially if there is any possibility they might be sued.

The reason AuRx went to Mexico to run its initial clinical trial was purely monetary. It cost far less to run the trial in Mexico than it would have in the US. The science had met incredible resistance at each step of the way. The reviewers of Dr. Aurelian�s first paper on the use of the AuRx recombinant in mice said that it shouldn�t be published because it wouldn�t work in guinea pigs. The reviewers of the paper on the use of the recombinant in guinea pigs said it wouldn�t work in man. At each step there have been a majority who said it wouldn�t work but it has. That�s the reason that we at AuRx have persevered. At every step the science has been successful. And at this point it has worked in man (in a trial for safety and dose studies in Mexico) with a complete cessation of all symptoms for 44% of the people tested and with only 12% having lesions in over one year.

When are the large companies going to believe? Apparently, only when you show them there is a reason to do so.

Our thoughts on their reasons. We think they are wrong. We think you deserve better and we�re trying to find a way to fund the trials necessary to gain approval. To that end we would like to be able to tell them that we have a registry of persons for clinical trials that is so large that it shows their scepticism is unwarranted. We believe that people with genital herpes want a cure!

� GJC

P.S. Please sign up on the confidential registry if you are afflicted with genital herpes.