SAN DIEGO, CA, Nov. 17 /PRNewswire-FirstCall/ -- Stressgen Biotechnologies (TSX:SSB) announced today a 40 percent response rate in a 21-patient trial of its lead drug product candidate, HspE7, in high grade cervical dysplasia. Patients in the study were scheduled to undergo Loop Electrocautery Excision Procedure (LEEP), a standard surgical procedure for patients with high grade dysplasia, to remove the affected area and to evaluate the effect of HspE7. This result is an early response rate for HspE7 as the LEEP was performed only two months following the last dose of drug. The trial was sponsored by the Norris Comprehensive Cancer Center of the University of Southern California (USC) in Los Angeles, California.
"The HspE7 construct appears to be active in high grade cervical dysplasia," said the Principal Investigator of the trial, Dr. Lynda Roman, Associate Professor of Obstetrics and Gynecology of the Keck School of Medicine at the University of Southern California (USC). "Further investigation of this novel method of treatment is clearly warranted in this important disease."
Immunological responses were measured in most of the patients. "After vaccination 64 percent (nine of fourteen patients tested) developed a specific immune response to viral antigens related to the cause of the disease," said Dr. Jeffrey Weber, Associate Professor of Medicine and Molecular Microbiology and Immunology, Keck School of Medicine at USC.
"This is the earliest time point at which we have seen major responses of HspE7 in any of our dysplasia studies," stated Dr. John
, Senior Vice President of Clinical Research for Stressgen. "Data from several cervical dysplasia studies are expected to be available by mid-2005. We will use these data to guide our Phase III development plans for the indication of recurrent or residual high-grade dysplasia in women who have failed to achieve an adequate response with LEEP." Such trials will use our commercial grade material that is expected to be available mid-2005.
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 news release contains forward-looking statements that are subject to risks and uncertainties, including those about plans to develop HspE7 for cervical dysplasia and timelines for commercial grade material. The actual results may differ materially from the implications of our forward-looking statements due to factors including the possibility that future clinical results will not be consistent with early responses, the need for regulatory approval for HspE7, our dependence on collaborators and our need for additional capital. For more details regarding these and other risks, see our most recent quarterly report on Form 10-Q, filed with the U.S. Securities and Exchange Commission and Canadian regulatory authorities.
Donna Slade Jennifer Matterson
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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; JenniferMatterson, Communications Coordinator, 350-4243 Glanford Avenue, Victoria, BCCANADA V8Z 4B9, Tel: (250) 744-2811, Fax: (250) 744-3331,email@example.com