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Biotech / Medical : Stressgen (VSE: SSB) -- Ignore unavailable to you. Want to Upgrade?

To: Heat Shock who wrote (198)	10/10/2002 6:00:15 PM
From: Heat Shock	Read Replies (1) \| Respond to of 236

To all, Stressgen announces presentation of new Phase II HspE7 data on genital warts and anal dysplasia at HPV 2002 The Company's Novel Immunotherapeutic, HspE7, Demonstrates Efficacy and Durable Response Over 24-Months PARIS, FRANCE, Oct. 7 /CNW/ - Stressgen Biotechnologies Corporation (TSX:SSB) will present data that the Company's lead product, HspE7, achieved complete responses of genital warts among a clinically significant percentage of patients for up to twenty-four months. New data were presented at the 20th International Papillomavirus Conference from three data sets of patients treated with HspE7, the Company's novel human papillomavirus (HPV)-specific immunotherapeutic. These data include new analysis of previously reported Phase II trial in genital warts; 24-month data from a retrospective study of genital warts patients enrolled in an anal dysplasia trial; and long-term follow-up of a Phase II anal dysplasia trial. "We are very pleased that the clinical experience with HspE7 in more than 350 patients continues to support its potential in the treatment of several diseases caused by human papillomavirus (HPV) infections," said Daniel L. Korpolinski, President and Chief Executive Officer of Stressgen. "Given the positive and long-term durable response that some patients with genital warts in these trials are experiencing, we believe that our novel immunotherapeutic represents an exciting step forward in treating serious HPV-related conditions. We look forward to the continued clinical success of HspE7, which has the potential to be the first immunotherapeutic available to treat chronic infectious diseases." New Secondary Endpoint Analysis of Phase II Placebo-Controlled Study in Genital Warts: Subgroup analysis showed that women treated with HspE7 at six months achieved a 62 percent complete response (CR) rate compared to 20 percent from the placebo group. It is estimated that 67 percent of the one million new genital warts patients per year in the U.S. who seek treatment are women. In this same study, men with anal and perianal warts treated with HspE7 achieved a 42 percent CR rate versus 25 percent for the placebo group. Consistent with data reported with imiquimod, women appeared to respond better than men and men with penile warts responded less well than men with warts in other areas. Previously announced data in November 2001 evaluating wart area demonstrated a 53 percent median reduction of wart area versus 16 percent with placebo, an important clinical achievement. 24-Month Data From Retrospective Study in Genital Warts: New follow-up data from the Company's retrospective evaluation of anal dysplasia patients with concomitant anorectal warts show complete responses in 8 out of 10 patients who had been followed up for 24 months. Complete response is defined as the absence of all warts. In contrast, data from clinical trials of topical treatments report clearance of treated warts only. "We are extremely pleased with these results," said John R. Neefe, M.D., Senior Vice President of Clinical Development of Stressgen. "This level of complete response rate at 24 months is a clinically important outcome. All patients in the retrospective data set had internal anorectal warts, and the only available treatment for these patients is a painful surgical intervention. Of the complete responses seen at the 24-month observation point, 75 percent had persisted for at least a year. A major problem with genital warts is recurrence, and a therapeutic that could help these patients avoid multiple therapeutic and/or surgical interventions would be extremely beneficial to the patient and healthcare system." Long-term Follow-up of Patients in Open-Label Anal Dysplasia Phase II Trial Data at 15 months show that 95 percent of the patients who participated in the long-term follow-up achieved complete responses (44 percent) or partial responses (51 percent), meaning that virtually all of these patients potentially avoided the need for surgical intervention. The median time to first reduction in disease state was approximately 36 days after completion of the HspE7 regimen. Most patients in both the genital warts and anal dysplasia Phase II clinical studies carried multiple human papillomavirus types. The data from these trials are compatible with the proposition that treatment with HspE7 induces cross reactivity to multiple HPV types, suggesting that HspE7 will have broad activity in several HPV sexually transmitted diseases. About Stressgen Biotechnologies Corporation Stressgen, a biopharmaceutical company, focuses on the discovery, development and commercialization of innovative, proprietary CoVal(TM) fusion therapeutics for the treatment of infectious disease and cancer. In its current clinical trials, the Company is testing 500 mcg of HspE7 given subcutaneously three times, within a 60-day regimen, to treat several indications. The Company also has a program to evaluate CoVal(TM) fusions in hepatitis B and has initiated research studies to evaluate its CoVal(TM) fusion technology in the treatment of hepatitis C, herpes simplex and HIV. Stressgen, through its bioreagent business, is an internationally recognized supplier of research products used by scientists worldwide for the study of cellular stress, apoptosis, oxidative stress and neurobiology. In June 2002, Stressgen announced a Collaboration Agreement with Roche for the co-development and global commercialization of HspE7, Stressgen's lead product candidate for HPV-related diseases. HPV is one of the most common sexually transmitted diseases, estimated to infect over 50 percent of the sexually active population. There are 5.5 million new cases of genital HPV infection diagnosed per year in the U.S. alone, including over one million cases of genital warts. In addition to genital warts and recurrent respiratory papillomatosis, HPV infection can cause cervical cancer and a variety of precancerous conditions, including anal and cervical dysplasia. The Company is a member of the S&P/TSX Composite Index and is publicly traded on the TSX Toronto Stock Exchange under the symbol SSB. About CoVal(TM) Fusions Stressgen capitalizes upon the immunostimulatory powers of heat shock proteins utilizing recombinant technology to fuse, or covalently link, a stress protein with a protein antigen to create a single hybrid protein designed to trigger the immune system to recognize that antigen. For more information about our CoVal(TM) fusion technology, or Stressgen, please visit us at our website located at www.stressgen.com. newswire.ca Conference call 24 Oct. Heat.