Antiviral Activity Seen With Gilead's Cidofovir

Gilead Sciences Inc says that data from a Canadian placebo-controlled Phase I/II clinical study of single-dose cidofovir topical gel in immunocompetent patients with recurrent genital herpes lesions showed significant evidence of antiviral activity. These data were scheduled to be presented at the Ninth International Conference on Antiviral Research in Urabandai, Japan, by clinical investigator Joseph Sasadeusz of Vancouver, Canada-based Viridae Clinical Sciences.

According to Viridae president Stephen Sacks, a recognized authority in the treatment of viral diseases, "these preliminary data provide clear evidence of an antiviral effect in patients with recurrent genital herpes. They are very promising results that warrant further study." Based on these Canadian data, Gilead will conduct larger Phase II/III studies. The product has also recently entered into clinical testing in Europe (Marketletter April 8).

The Canadian study was designed to determine the safety of a single dose of cidofovir topical gel directly applied to genital lesions and to obtain preliminary evidence of antiviral activity. In the study, 96 patients received one application of either cidofovir at one of three strengths (1%, 3% and 5%) or an inactive placebo gel. Comparable numbers of male and female patients were enrolled and randomized to each of the dose levels. The intent of this Phase I/II study was to assess initial safety and efficacy and to guide future clinical development plans.