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

To: Heat Shock who wrote (176)	12/18/2001 5:59:18 PM
From: Heat Shock	Read Replies (1) \| Respond to of 236

To all: after-the-bell PR: High points to me were 1) time dependent response. The longer the time, the greater the efficacy 2) plenty of "complete responders" 3) HspE7 acts against disease conditions caused by multiple sub-types of the Human papillomavirus (HPV) 4) obvious potential use as a first line treatment with no other treatments necessary 5) trivial side effects HspE7 potentially eliminates the need for surgical intervention and improves the quality of life in anal dysplasia patients 15-month Data from Ongoing Registry Indicate Continued Improvement to Complete Responses and Durability CHICAGO, IL, Dec. 18 /CNW/ - Stressgen Biotechnologies Corporation (TSE:SSB) today presented at the 41st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) the final data results from its phase II low dose and high dose HspE7 clinical trials in anal dysplasia. A summary of these results was previously announced on November 29, 2001. "HspE7 has the potential to be an effective, first line approach to treatment for this very serious disease," said Joel M. Palefsky, M.D., one of the foremost international experts in AIN, and Director of the General Clinical Research Center and Professor of the Departments of Laboratory Medicine and Stomatology at the University of California, in San Francisco. "HspE7 could potentially eliminate the need for surgical intervention and improve the quality of life for these patients." The following observations cover all 86 patients from the randomized, placebo-controlled low dose study, all 82 patients who continued into the subsequent open-label high dose study, and data from 66 patients in a long- term registry study as of October 29, 2001. Of the patients who received the high dose of HspE7 at three months, 67% of the patients improved from high grade dysplasia, a precursor to cancer, to low grade dysplasia, requiring no surgery. After six months, 76% of the patients had improved to low grade dysplasia. Based on these final data, the spontaneous complete response rate of anal dysplasia is estimated to be 0% over 12 months. At the end of the study, any patients responding to treatment in the open label study were permitted to enter a registry where no additional treatment was administered. Patients were followed every three months by anoscopy and anal Pap smear. Of these patients, 55% were complete responders at the 15- month time point of the registry. Of the patients achieving a complete response, 86% remained complete responders at 15 months. This study is ongoing and all patients will be followed at quarterly intervals to a maximum of 24 months. Many patients in these studies had concomitant internal and external genital warts. Most of these patients had major improvement of their warts including 73% complete responders in 18 months, as defined by complete warts disappearance, demonstrating HspE7's broad-spectrum activity over multiple HPV subtypes. In the low dose study, there was no difference in the rate of response between patients who received the low dose of HspE7 (100 mcg x 3) and patients who received placebo. Prior treatment at the low dose did not improve the treatment response to the high dose of HspE7 (500 mcg x 3). HspE7 continues to exhibit a favorable side effect profile. The most common adverse event related to HspE7 was mild or moderate injection site reaction. About Stressgen Biotechnologies Stressgen is a public biopharmaceutical company focused on the development and commercialization of innovative stress protein-based 'fusion' immunotherapeutics. The Company is developing a broad range of products for the treatment of viral infections and related cancers. In addition to targeting HspE7 in HPV-related diseases, the Company also has a program to evaluate stress protein fusions in hepatitis B and has initiated research studies to evaluate its heat shock protein 'fusion' technology in the treatment of several other indications. Stressgen is also an internationally recognized commercial supplier of research products used by scientists worldwide for the study of cellular stress, apoptosis, oxidative stress and neurobiology. HspE7 is a novel immunotherapeutic for the treatment of diseases caused by the human papillomavirus ("HPV"), one of the most common sexually transmitted diseases, estimated to infect approximately 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, of which over 1 million represent cases of genital warts. In addition to warts, genital HPV infection can cause cervical cancer and a variety of precancerous conditions, including anal and cervical dysplasia. newswire.ca Heat.