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AuRx, Inc. For Release February 10, 2004

AuRx is pleased to announce the completion of collection of the one year data in its Phase I/II clinical trial carried out in Mexico City. Results of the low dose were reported earlier by the clinical group with lead author, Dr. Gerado Casanova in Cutis (Oct , 2003). In the new study of a higher dose regimen , the AuRx recombinant therapy was used at a dose of 2x106 pfu, with injections at 10 and 28 days after the initiation of the presenting lesions. The therapy was well tolerated with no side effects other than those also seen in the placebo. Recurrences were completely eliminated in 44% of the vaccinated patients for a full year. This compares to 13% without recurrences in the placebo group (p = 0.024) at one year. There was also a significant reduction in the number of episodes relative to the previous year (p<0.001) and in the number of recurrent episodes in the vaccinated relative to the placebo group (p=0.04).

Dr. Casanova said that the patients were thrilled to be in the trial. The patients had between 5 and 24 lesional episodes in the previous year. In addition, all patients experienced other symptoms such as burning, itching, fever, pain, and problems in urination. Prevention of these secondary symptoms is not normally considered in trials of drugs for herpes, rather lesions are the only symptom scored because they are easily visible to both the physician and the patient. In this trial, a much more difficult to achieve goal was sought - the complete cessation of all symptoms as reported by the patient. Many persons who are afflicted with genital herpes begin to associate unrelated symptoms with their genital herpes and also feel that these symptoms are worse than the lesions. As one patient said, "every twinge brings on the fear of another outbreak."

A group of dermatologists at 5 leading hospitals in Mexico City, with Dr. Gerado Casanova as the lead author of the study on the low dose arm, published in Cutis, found that the number of recurrent episodes per month for the vaccinated patients was significantly reduced when compared to that documented for the previous year (p<0.001) and similar protection was still seen at 12 months after treatment in the lower dose of the trial.

Genital herpes is present in epidemic proportions in the US and has been estimated to have a cost of over $60 billion in the next 25 years. These losses are in addition to the nearly $1 billion spent in the US by patients now treating the disease with nucleoside analogs (acyclovir, valacyclovir, famcyclovir and penciclovir) . Nucleoside analogs have limited efficacy as they only reduce the number of days patients have lesions by 10-20% and must be taken rigorously for suppression of genital herpes. It has been estimated that screening for HSV and treatment for suppression would cost $363,000 for every case of neonatal herpes prevented.


AuRx, Inc., is a privately held company based near Baltimore, Maryland.