Genital Warts

September 11, 2006

Nventa released positive results from a phase II trial of HspE7, a therapeutic vaccine, for the treatment of internal and external anal genital warts. This single-arm trial enrolled 30 HIV-negative men, all of who had internal warts and 10 of who had external warts. Subjects received three monthly injections of HspE7 at 1500 mcg and followed for 48 weeks. Treatment was well tolerated with headache being the most commonly reported adverse event (27%). Efficacy data revealed that at week 24, 11% of the subjects had complete response, defined as absence of warts and 67% had partial response. At 48 weeks 33% had complete response while 48% had partial response and a 71% mean decrease in volume of the genital warts was observed. Of the subjects with external genital warts, 70% had complete response. Based on these results, Nventa plans to move HspE7 into future trials.

April 12, 2004

MediGene reported positive results of their European phase III trial investigating Polyphenon E Ointment for the topical treatment of genital warts. Results showed that the primary endpoint of the study was met, with 53% of subjects treated with the 15% Polyphenon E and 51% of subjects treated with 10% Polyphenon E completely recovering from all existing and newly appearing warts, compared with 37% treated with placebo. The study’s secondary endpoint, recovery from all pre-existing warts, was also met in both formulations, with 55% at 15% and 53% at 10% recovering, compared to 36% for placebo. The trial was designed to investigate two formulations of Polyphenon E (15% and 10%) administered three times daily for up to 16 weeks. The randomized, double-blind, placebo-controlled study enrolled more than 500 subjects at 48 hospitals in seven European countries and South Africa. MediGene is also planning phase II trials of Polyphenon E Ointment for the treatment of actinic keratosis based on these results.

August 19, 2002

Results of two international studies involving over 700 subjects indicated that imiquimod cream 5% is effective in treating women with external genital warts. 75% of subjects treated with imiquimod experienced complete clearance of their warts. Although 15% of subjects had warts return six months after finishing treatment, re-application of the product for an additional 16 weeks cleared the warts in 75% of those subjects. Imiquimod is manufactured by 3M Pharmaceuticals.