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news Thursday August 8, 7:59 am Eastern Time Press Release SOURCE: StressGen Biotechnologies Corp. Stressgen announces completion of enrollment in Phase II clinical trial of HspE7 for recurrent respiratory papillomatosis in children Orphan Drug Status for RRP May Provide Fastest Route to Market VICTORIA, BC and SAN DIEGO, CA, Aug. 8 /PRNewswire-FirstCall/ - Stressgen Biotechnologies Corporation (TSX:SSB - News) announced today that it has completed enrollment in its Phase II clinical trial of HspE7 for pediatric patients suffering from a human papillomavirus (HPV)-related disease called recurrent respiratory papillomatosis (RRP), essentially warts of the upper airways. According to a survey published in 1995, there were approximately 6,000 active cases and 2,300 new cases of RRP diagnosed annually. ADVERTISEMENT Conducted at multiple clinical sites in the U.S., the trial involves 27 pediatric patients that currently require frequent surgery to manage their disease. Patients are receiving 500 mcg doses of HspE7 administered three times at monthly intervals. The endpoint for this trial is to achieve an increased interval between clinically required surgeries. Data from this study could be available as early as this year. The Company was granted orphan drug status for HspE7 for the RRP indication from the U.S. Food and Drug Administration (FDA) in March of 2001. HspE7, a novel immunotherapeutic, developed with Stressgen`s proprietary heat shock protein fusion technology, CoVal(TM) fusions, was developed to invoke a potent immune response to HPV. Stressgen, in collaboration with Roche, is developing HspE7 for a broad range of HPV-related diseases. "The papillomas in RRP almost always recur," said John R. Neefe, M.D., Senior Vice President of Clinical Research for Stressgen Biotechnologies. "Frequent recurrence leads to repeated painful surgical procedures, sometimes hundreds of procedures over a lifetime. This pattern of disease is deeply frustrating to affected children, their families, and to the medical professionals who treated them." "HspE7 could become effective medical therapy for RRP," added Dr. Neefe. "By reducing or preventing recurrence, HspE7 could break the unhappy cycle of repeated surgeries. Genital warts, caused by the same types of HPV as RRP, also have a pattern of frequent recurrences, which fail to respond to available therapies. Stressgen`s clinical data have already suggested that HspE7 can break the recurrence pattern in genital warts." "This is yet another significant clinical milestone for Stressgen, and marks important, ongoing progress for our lead compound, HspE7, for the potential treatment of a broad range of HPV-related conditions," said Daniel L. Korpolinski, President and Chief Executive Officer of Stressgen. "Physicians need a new treatment option that can address the recurrence associated with HPV-related diseases. We are hopeful that HspE7, with its orphan drug designation for RRP, could be the first drug available to treat the symptoms associated with this tragic disease and potentially manage or even prevent recurrence. Ultimately, HspE7 may be demonstrated to improve the quality of life for children suffering from this dreadful condition. We remain on track with our timelines for filing a biologics license application (BLA) for marketing approval for RRP with the FDA." About Stressgen Biotechnologies Corporation Stressgen, a biopharmaceutical company, focuses on the discovery, development and commercialization of innovative CoVal(TM) (see below) fusion immunotherapeutics. The Company is developing a broad range of products for the treatment of viral infections and related cancers. In addition to developing HspE7 for diseases caused by human papillomavirus ("HPV"), 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 is also 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. HPV is one of the most common 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 a variety of precancerous conditions, including anal and cervical dysplasia. The Company is a member of the S&P/TSX Composite Index and is publicly traded on the TSX Toronto Stock Exchange under the symbol SSB. About CoVal(TM) Fusions 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 our CoVal(TM) fusion technology, or Stressgen, please visit us at our website located at www.stressgen.com. This news release contains forward-looking statements that involve risks and uncertainties, including statements regarding the release of data from clinical trials and expected uses of immunotherapeutics. Factors that may cause the ultimate results to be materially different from those implied by such statements include risks of delays in conducting clinical trials and differences between the results of preliminary research and clinical trials. Please refer to our periodic reports filed with Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission for a more comprehensive discussion of these and other risks. Stressgen Contacts: Donna Slade Jennifer Matterson Director, Investor Relations Communications Coordinator 10241 Wateridge Circle, Ste. C200 350-4243 Glanford Avenue San Diego, CA USA 92121 Victoria, BC CANADA V8Z 4B9 Tel: 858/202-4900 Tel: 250/744-2811 Dir: 858/202-4945 Fax: 250/744-3331 Fax: 858/450-6849 jmatterson@stressgen.com dslade@stressgen.com SOURCE: StressGen Biotechnologies Corp. |
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