To all: Stressgen's immunotherapy to be used in trials by U.S. National Cancer Institute (NCI) for patients who are HIV-positive.
Stressgen announces the initiation of enrollment of patients for the first of multiple trials planned to evaluate HspE7 in HPV-related dysplasia and cancer
First NCI-Sponsored Trial Tests Stressgen's Proprietary Fusion Technology in HIV-Positive High-Risk Dysplasia Patients
SAN DIEGO, CA, Jan. 15 /CNW/ - Stressgen Biotechnologies Corporation (TSX:SSB) today announced that the AIDS Malignancy Consortium sponsored by the U.S. National Cancer Institute (NCI) has initiated the first of several planned trials with HspE7, the Company's novel immunotherapeutic, in patients with human papillomavirus (HPV)-related diseases including cervical and anal dysplasia, as well as cervical cancer. The study is being performed under a Clinical Trials Agreement between Stressgen and the NCI.
The first Phase I/II trial will evaluate the clinical and immunological response of escalating doses of HspE7 in HIV-positive patients with high-grade anal dysplasia. Other NCI-sponsored trials will involve testing various dose regimens of HspE7 in patients with cervical dysplasia or cervical cancer.
Preclinical data suggest that HspE7's activity is independent of CD4+ T cells, supporting the potential use of this product for the treatment of immunocompromised patients whose CD4+ T cells may be depleted or significantly impaired. HspE7 is an application of Stressgen's proprietary CoVal(TM) fusion technology in which a heat shock protein has been covalently linked to an HPV antigen.
"HPV infection is much more serious in HIV-positive people whose immune systems are compromised," said John R. Neefe, M.D., Senior Vice President of Clinical Development at Stressgen. "Individuals who are HIV-positive are more likely to develop genital warts, as well as high-grade cervical or anal dysplasia, precursors to cervical or anal cancer, as a result of HPV infection. Moreover, dysplasias are more aggressive and more difficult to treat in individuals who are HIV-positive. Because anti-HIV drugs have been so successful in keeping people infected with HIV alive longer, the risk of progression from dysplasia to cancer has become more important."
"We are excited that the NCI has recognized the potential value of HspE7 in treating patients with diseases caused by HPV," said Daniel L. Korpolinski, President and Chief Executive Officer at Stressgen. "Our Phase II clinical trial data to date have demonstrated that 95 percent of patients with high- grade anal dysplasia who are treated with HspE7 improved to low-grade, potentially avoiding surgery; 44 percent of the patients achieved complete remission and are disease-free at 15 months, suggesting that these improvements are durable. We're continuing to follow patients to 24 months. Among these patients, the most common side effect has been mild to moderate reaction at the site of injection. Stressgen's clinical data further suggest that HspE7, unlike other HPV type-specific vaccines, produces responses in patients with different HPV types, which of course would broaden its use as a therapeutic. We are eager to determine whether results are comparable in patients who are HIV-positive, as preclinical data suggest."
About Human Papillomavirus (HPV)
HPV is one of the most common causes of 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 anal cancer and a variety of precancerous conditions, including anal and cervical dysplasia. More than 70% of cervical dysplasia and cancer are caused by HPV types 16 and 18, while the predominant types associated with genital warts are HPV types 6 and 11.
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. HspE7 is a fusion of a heat shock protein and the E7 protein from HPV type 16. For more information about our CoVal(TM) fusion technology, or Stressgen, please visit us at our website located at www.stressgen.com.
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. The Company has an ongoing Phase III clinical trial with HspE7 treating patients with high- grade anal dysplasia, and a Phase II trial with HspE7 treating children with recurrent respiratory papillomatosis, essentially warts of the upper airways.
In addition to developing HspE7 for diseases caused by human papillomavirus, the Company 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.
This news release contains forward-looking statements that involve risks and uncertainties, including statements about additional planned clinical trials and potential findings from such trials. Factors that could cause future results to differ materially from our current expectations include, but are not limited to: reliance on collaborators, uncertainties as to the timing and results of human clinical trials; the heightened volatility in our stock price due to changes in the S&P/TSX Composite Index and the factors discussed in Stressgen's most recent Form 10-Q filed with the U.S. Securities and Exchange Commission and Canadian Securities regulatory authorities. Because our forward-looking statements involve risks and uncertainties, actual results may differ materially from our current expectations. We provide this information as of January 15, 2003, and expressly disclaim any duty to update the information contained in this press release.
For further information: Stressgen Contacts: Donna Slade, Director, Investor Relations, 10241 Wateridge Circle, Ste. C200, San Diego, CA, USA, 92121, Tel: 858-202-4900, Dir: 858-202-4945, Fax: 858-450-6849, dslade@stressgen.com; Jennifer Matterson, Communications Coordinator, 350-4243 Glanford Avenue, Victoria, BC, CANADA, V8Z 4B9, Tel: 250-744-2811, Fax: 250-744-3331, jmatterson@stressgen.com
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