SAN DIEGO, CA, Dec. 2 /PRNewswire-FirstCall/ -- Stressgen Biotechnologies (TSX:SSB) announces that it has completed enrollment of 30 patients in the Phase II clinical trial of its lead product candidate, HspE7, to treat internal genital warts, a human papillomavirus (HPV)-related disease. Surgery remains the principal means of treatment for internal genital warts today.
The study is a single arm pilot study in 30 patients conducted by Dr. Goldstone, a specialist in the field of HPV-related diseases. The primary endpoint of the trial will be complete response measured by complete clearance of baseline internal warts. The study is on schedule and twelve-month data are estimated to be available at the end of 2005.
"HspE7 could provide a much needed therapeutic option for patients with internal genital warts," commented Stephen E. Goldstone, M.D., a Fellow of the American College of Surgeons and clinical assistant professor at The Mount Sinai School of Medicine in New York City and lead investigator in this trial. "Surgical procedures can be serious, painful and debilitating."
Stressgen is finalizing a protocol with the U.S. Food and Drug Administration to begin a Phase III pivotal clinical trial in its first indication for HspE7, recurrent respiratory papillomatosis, (RRP), a serious disease caused primarily by the same HPV types that cause genital warts.
"We are aggressively pursing our first indication for HspE7 in RRP, and advancing the utilization of HspE7 across a broad range of serious HPV-related diseases," said John R. Neefe, M.D., Senior Vice President of Clinical Development at Stressgen.
About Stressgen Biotechnologies Corporation:
Stressgen, a biopharmaceutical company, focuses on the discovery, development and commercialization of innovative therapeutic vaccines for the treatment of infectious diseases and cancer. The corporation is publicly traded on the Toronto Stock Exchange under the symbol SSB.
About HspE7, Lead Product Candidate:
HspE7 is a novel CoVal(TM) fusion therapeutic vaccine for the treatment of diseases caused by the human papillomavirus (HPV), one of the most common causes of sexually transmitted diseases in the world. An estimated 80 percent of sexually active men and women are infected by genital HPV at some point in their lives. Approximately 5.5 million new sexually transmitted HPV infections are reported in the U.S. each year. At least 20 million people in the U.S. are already infected. HPV infection can result in diseases including internal and external genital warts and precancerous conditions, such as cervical and anal dysplasia. Precancerous HPV-related conditions can progress into life- threatening diseases, including cervical, anal, and head and neck cancers.
About CoVal(TM) Fusion Proteins:
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 CoVal(TM) fusion technology, or Stressgen, please visit the website located at http://www.stressgen.com/.
This press release contains forward-looking statements including statements about the expected availability of data from the genital warts trial and plans for a Phase III trial in RRP. Actual results could differ materially from those implied by our forward-looking statements due to risks including our dependence on collaborators, uncertainties in the regulatory approval process and our need for additional capital. Please refer to our most recent Quarterly Report on Form 10-Q, filed with the U.S. Securities Exchange Commission and Canadian securities regulators, for more information on these and other risks.
Donna Slade Jennifer Matterson
Director, Investor Relations Communications Coordinator
6055 Lusk Boulevard 350-4243 Glanford Avenue
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Stressgen Biotechnologies Corp.
CONTACT: Stressgen Contacts: Donna Slade, Director, Investor Relations,6055 Lusk Boulevard, San Diego, CA USA 92121, Tel: (858) 202-4900,Dir: (858) 202-4945, Fax: (858) 450-6849, firstname.lastname@example.org;Jennifer Matterson, Communications Coordinator, 350-4243 Glanford Avenue,Victoria, BC CANADA V8Z 4B9, Tel: (250) 744-2811, Fax: (250) 744-3331,email@example.com