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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.
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