AEGiS-PRn: StressGen initiates HspE7 Phase III trial in HPV-related anal dysplasia: CDC reports HPV second only to HIV in US STD related healthcare costs PRNewswireImportant note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
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StressGen initiates HspE7 Phase III trial in HPV-related anal dysplasia: CDC reports HPV second only to HIV in US STD related healthcare costs

PRNewswire - November 6, 2000


VICTORIA, BC, Nov. 6 /PRNewswire/ - StressGen Biotechnologies Corp. (TSE: SSB) announced today that it has initiated patient treatment in a Phase III clinical trial to investigate HspE7 as a novel immunotherapeutic for anal dysplasia (AIN) caused by the human papilloma virus (HPV). HPV is one of the most common sexually-transmitted diseases (STDs) in the world. StressGen also has active Phase II HspE7 studies in women with HPV-related cervical dysplasia and cervical cancer, and plans to initiate a Phase II study in genital warts.

The Company previously reported preliminary data from the first patients in its open label Phase II trial in anal dysplasia at two scientific conferences, HPV 2000 in Barcelona in July, 2000, and at Cancer Vaccines 2000 in New York City in October, 2000.

"More than 60 patients have now been treated in the Phase II trial, and the positive results observed serve as the basis of the new Phase III trial," said Dr. John Neefe, VP Clinical and Regulatory Affairs of StressGen Biotechnologies. "In addition, observation of responses in patients with various HPV types, including the types most commonly associated with genital warts, reinforce the potential of HspE7 as a broad-based therapeutic for HPV- related diseases."

This is the first trial in StressGen's Phase III program for the development of HspE7. This double-blind placebo-controlled study will involve 128 patients at multiple centers in the United States. Clinical efficacy will be determined by regression of AIN using standard pathological criteria. "The initiation of this Phase III trial represents a significant milestone for StressGen. It is a clear indication of the Company's confidence in the HspE7 clinical program and in our Hsp fusion technology as a platform for developing novel immunotherapeutics," said Daniel Korpolinski, President and CEO of StressGen Biotechnologies. "Public awareness of the link between HPV infection and certain cancers, such as cervical cancer which is screened for in pap tests, has increased significantly. This is important because HPV infection is extremely common and can result in significant morbidity. It is well recognized that existing approaches to treatment do not address the underlying pathology and it is inevitable that demand will grow to look at new approaches to treatment. We believe that HspE7 is well positioned to be seen as a potential solution to this major public health issue."

There are 5.5 million new cases of genital HPV infection diagnosed per year in the US alone, and according to a report published by the Division of STD Prevention, Centers for Disease Control and Prevention, HPV is second only to HIV in STD-related US healthcare costs (http://http://www.cdc.gov/nchstp/dstd/Reports_Publications /99HPVReport.htm). Genital HPV infection can cause a variety of precancerous conditions, including anal and cervical dysplasia. Left undiagnosed, or untreated, dysplastic cells can become cancerous. HPV is also responsible for genital warts and laryngeal warts as well as some head and neck cancers.

HspE7 is based on StressGen's proprietary Hsp fusion technology. HspE7, a recombinant fusion product, 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 the 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 abnormal cells.

StressGen Biotechnologies is a biopharmaceutical company focused on the development and commercialization of innovative stress protein-based immunotherapeutics. The Company is developing a broad range of products for the treatment of viral infections and related cancers. StressGen's lead product HspE7 targets a variety of HPV-related diseases. StressGen has also initiated research studies to evaluate the technology in the treatment of asthma and allergy as well as Hepatitis. Through its Biochemical Division, StressGen is also an internationally recognized supplier of research products for the study of cellular stress, apoptosis, oxidative stress and neurobiology. These products are used by scientists worldwide.

This foregoing press release may contain statements that are not based on historical fact, including, without limitation, statements containing the words "believes", "may", "will", "intends", "plans", "expects" and words of similar import. Such statements may constitute "forward-looking" statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. A number of factors could cause actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements implied by such statements. Such factors include, but are not limited to, those with respect to the timing of regulatory submissions and approvals, the ability of the Company to continue to develop its products (including HspE7), the Company's ability to maintain or expand its intellectual property position, the timing and success of planned or existing clinical trials and anticipated levels of revenues and expenses and others, all as described Company's Registration Statement on Form F-10 and other filings with the U.S. Securities and Exchange Commission.

SOURCE StressGen Biotechnologies Corp.


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