Press Releases:Press Release - Baltimore, MD February 12, 2004

AuRx Therapy Registry

In anticipation of additional clinical trials for its recombinant therapy, AuRx, Inc. is seeking volunteers to participate who are currently infected with HSV-2. Interested persons who have been diagnosed with genital herpes by a physician are asked to fill out the confidential contact form on the AuRx website. Confirmation of this diagnosis by any method would be desirable but is not necessary if the patient has had a minimum of four outbreaks in the previous year or is currently on suppressive therapy with at least one outbreak in the previous year. It is emphasized that the trials for this therapy will involve only persons who currently have genital herpes. Persons who do not have genital herpes will not be considered for inclusion in any trials run.

A minimum of 5,000 volunteers is sought. AuRx intends to close the registry on May 31, 2004. This registry is being compiled to shorten the recruitment phase of clinical trials of the AuRx recombinant therapy. The registry will also aid in the selection of clinical centers for the trial which are near the patient populations.

About Genital Herpes
As many as 60 million persons in the United States are now infected with genital herpes (HSV2) (infection rate of 22.9% in 1994 and 1.6 million new infections each year). This infection usually results in 6 outbreaks per year in which sores occur in the genital area accompanied by pain, fever, itching, burning or problems with urination. Infection also results in a high incidence of failed relationships and damage to self-esteem with a resultant high social cost. At the present time no cure is available and treatment is by nucleoside analog for reduction of lesion days. Data are not available on prevention of symptoms other than lesions by the nucleoside analogs.

About the AuRx Therapy.

One clinical trial has been run in Mexico. In that trial, the side effects of the therapy were no worse than receiving a sugar pill and were equal to placebo. Side effects included headaches, swelling and redness at the site of injection and mild pain (For a full discussion of the trial, please see the full paper published in Cutis). As reported at the Bereston Memorial lecture and the Pan American Society for Clinical Virology, two doses of therapy given 14 days apart completely prevented all signs and symptoms in 43.5% of the persons treated. Only 12% of the treated patients experienced lesion formation. The most common symptom experienced by treated persons was a burning sensation in the genital region (18%). Lower percentages of treated patients experienced pain or problems in urination. In the year prior to the trial, all enrollees had experienced at least 5 lesional outbreaks. In followup of the patients in the trial, in the high dose arm there were no persons who had been successfully treated at six months who experienced any signs or symptoms at 1 year. No correlation in effectiveness in patients also infected with HSV1 (cold sores or fever blisters) or difference in response rate between males and females was seen in this trial.