To: Heat Shock who wrote (160 ) 4/10/2001 6:44:47 PM From: Heat Shock Read Replies (1) | Respond to of 236 To all: new PR- Stressgen's Genital Warts Program Ahead of Schedule Due to Early Completion of Patient Enrollment in Phase II Trial First Genital Warts Data to be Presented in June 2001VICTORIA, BC, April 10 /CNW/ - Stressgen Biotechnologies Corporation (TSE: SSB) announced today that patient enrollment in its Phase II clinical trial investigating HspE7 as a novel immuno-therapeutic for genital warts caused by human papillomavirus (HPV) has been completed ahead of schedule. There are 5.5 million new cases of genital HPV infection diagnosed per year in the U.S. alone, of which approximately one million represent new cases of genital warts. This randomized double-blind placebo-controlled study initiated in January 2001 saw rapid enrollment of the protocol-required 52 patients at multiple study centers in the United States. Data from this trial will be analyzed in the fourth quarter of 2001. Effectiveness of HspE7 will be assessed as regression of warts by standardized clinical criteria. These data will then be submitted to an appropriate scientific conference for public presentation. "We are pleased with the rapid enrollment for our genital warts clinical trial, and the steady progress made in the HspE7 clinical program," said Daniel L. Korpolinski, President and Chief Executive Officer of Stressgen. "Together with the recent announcement of orphan drug status for HspE7 for the treatment of recurrent respiratory papillomatosis (RRP), a serious HPV-related disease, these developments help us to evaluate the full potential for HspE7 as a crucial therapeutic solution to major public health issues." RRP is caused by the same HPV types that cause genital warts. In June 2001, retrospective data on genital warts will be presented at the American Society of Colon and Rectal Surgeon's Annual Meeting. These clinical observations were made during Stressgen's Phase II trial in anal dysplasia where a number of patients had concomitant genital warts. Stressgen is evaluating the potential of HspE7 as a broad based therapeutic for diseases caused by human papillomavirus (HPV). The Company currently has a number of clinical trials ongoing, including one Phase III trial, and several Phase II trials, and will soon initiate a clinical trial to evaluate HspE7 for recurrent respiratory papillomatosis. HspE7, a recombinant fusion product created with Stressgen's proprietary Hsp fusion technology, is composed of heat shock protein 65 (Hsp65) from Mycobacterium bovis BCG and the protein E7. As a member of the family of stress proteins, Hsp65 is known to elicit a powerful immune response. The E7 protein is derived from HPV and is involved in the malignant transformation of epithelial cells. E7 is a tumor-specific antigen and represents a precise target for the immune system attack on infected cells. newswire.ca Heat.