Press Release: August 31, 2004
AuRx, Inc. announces tentative approval by the Mexican Ministry
of Health to conduct Phase 3 Trials for Theraherp
AuRx, Inc. announced the tentative approval by the Mexican Ministry
of Health to conduct a confirmatory Phase 3 trial Theraherp. Theraherp,
also known as ICP10?PK, is a recombinant used to cause the body
to suppress lesions, as well as all other symptoms in those who
are infected with genital herpes.
The trial will be a placebo-controlled, double-blinded multi-center
trial in Mexico with a 6 month follow-up. The primary endpoint will
be prevention of lesions. This trial is designed to confirm the
efficacy found in the initial Phase I/II clinical trial carried
out in Mexico City. In that trial, Theraherp was very well tolerated
and recurrences of lesions were eliminated in 84% of the vaccinated
patients for a full year, while all signs and symptoms were prevented
in 44% of the patients for a full year. In patients having episodes
there was a statistically significant reduction in the number of
episodes relative to the previous year in the vaccinated group.
These results are far superior to those obtained with currently
available drugs.
AuRx expects the results from this Phase III trial to show efficacy
comparable to the earlier data and will lead to approval of Theraherp
for sale in Mexico.
AuRx, Inc. is a privately held company based in Maryland.
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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