PRESS RELEASE October 11, 2002 - AuRx, Inc., ANNOUNCES PUBLICATION
OF THE SUCCESSFUL RESULTS OF THE CLINICAL EVALUATION OF ITS THERAPEUTIC
VACCINE FOR GENITAL HERPES.
FOR RELEASE October 11, 2002
BALTIMORE, MD - 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<.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 49% of women and 39% 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.
For Additional Information Contact:
Gary J. Calton, President AuRx, Inc.
500 J McCormick Drive
Glen Burnie, MD 21061
410.590.7610
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