Stressgen presents new data indicating the majority of anal dysplasia patients improve with HspE7

Data Confirm Earlier Findings: 73% of Patients Downgrade from High Grade

to Low Grade Dysplasia



Apr 24, 2001, 01:00 ET from Stressgen Biotechnologies Corp.

    BETHESDA, MD, April 24 /PRNewswire/ - Stressgen Biotechnologies
 Corporation (TSE:SSB) announced today that additional preliminary Phase II
 data confirm previously reported activity of HspE7, a novel immunotherapeutic,
 for the treatment of a precancerous condition caused by human papillomavirus
 (HPV) called anal dysplasia (AIN). At the 5th International AIDS Malignancy
 conference, Joel M. Palefsky, M.D., one of the foremost international experts
 in AIN, reported updated results of an open-label Phase II trial in high grade
 anal dysplasia. Data from the first 22 consecutive patients were reported at
 the primary six-month evaluation point where 16 of 22 patients (73%)
 downgraded to low grade dysplasia. These data are consistent with the initial
 reports of this ongoing trial.
     "These data continue to support Stressgen's belief that HspE7 could
 become an important therapeutic option for HPV-related diseases such as anal
 dysplasia. Many patients now require some form of surgery - a potentially
 painful and debilitating procedure. HspE7 could potentially eliminate the need
 for surgery," said John R. Neefe, M.D., Vice President, Clinical Research and
 Regulatory Affairs of Stressgen. To date, no serious adverse events related to
 HspE7 treatment have been observed in the patients reported. Stressgen plans
 to analyze the final data from the completed Phase II AIN trial during the
 third quarter of 2001. The data will then be submitted for initial public
 presentation at an appropriate scientific forum. Stressgen's phase III trial
 in anal dysplasia is actively enrolling patients and is progressing according
 to schedule.
     "At the 5th International AIDS Malignancy Conference, it has become
 increasingly apparent that anal dysplasia is an important public health
 problem, especially among HIV-infected gay men," said Dr. Palefsky, Director
 of the General Clinical Research Center and Professor of the Departments of
 Laboratory Medicine and Stomatology at the University of California, San
 Francisco. "Anal dysplasia is more common than anyone had previously known,
 and it can have serious medical implications if left untreated. We now
 recognize that anal dysplasia affects many men with HIV infection. Worse, the
 incidence of anal cancer, which may be a consequence of anal dysplasia,
 appears to be increasing rapidly in this group. New approaches to the
 treatment of anal dysplasia are badly needed."
     The Company is evaluating the potential of HspE7 as a broad based
 therapeutic for diseases caused by human papillomavirus (HPV). The Company
 currently has a number of clinical trials ongoing, including one Phase III
 trial, and several Phase II trials, and will soon initiate a clinical trial to
 evaluate HspE7 for the treatment of a serious HPV-related disease, recurrent
 respiratory papillomatosis (RRP), for which the FDA recently granted orphan
 drug status. RRP is caused by the same HPV types that cause genital warts.
     HspE7, a recombinant fusion product created with Stressgen's proprietary
 Hsp fusion technology, 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 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 infected cells.
 
     Conference Call
     ---------------
     Stressgen will hold its First Quarter 2001 financial conference call on
 May 3, 2001 at 4:00 p.m. Eastern Time (1:00 p.m. Pacific Time). The call in
 number to access the call is 800/326-6186 in North America. A replay of this
 call will be available from May 3 at 3:00 Pacific Time through May 10, 2001.
 The playback number is: 800/558-5253, reservation number 18670407. To access
 information about the call, please log on to our website, www.stressgen.com.
 
     About Stressgen
     ---------------
     Stressgen is a public 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. In addition to
 targeting HspE7 in HPV-related diseases, the Company has also initiated
 research studies to evaluate its Hsp technology in the treatment of asthma,
 allergy and hepatitis. Stressgen is also an internationally recognized
 supplier of research products for the study of cellular stress, apoptosis,
 oxidative stress and neurobiology, which are used by scientists worldwide.
 
     This press release contains certain "forward-looking" statements within
 the meaning of the Private Securities Litigation Reform Act of 1995. These
 statements are based on the current expectations of our researchers, are
 subject to uncertainty and will require confirmation through additional
 studies. Forward-looking statements contained herein include statements about
 potential side-effects of HspE7, a potential treatment for anal dysplasia, and
 plans to initiate clinical trials which are subject to the ability to
 manufacture HspE7, successfully collaborate with third-parties and obtain
 regulatory approvals. More detailed information about these factors is set
 forth in our Annual Report on Form 10-K as filed with the Securities and
 Exchange Commission. We are not under any obligation to (and expressly
 disclaim any such obligation to) update or alter our forward-looking
 statements, whether as a result of new information, future events or
 otherwise.
 
 

SOURCE Stressgen Biotechnologies Corp.
    BETHESDA, MD, April 24 /PRNewswire/ - Stressgen Biotechnologies
 Corporation (TSE:SSB) announced today that additional preliminary Phase II
 data confirm previously reported activity of HspE7, a novel immunotherapeutic,
 for the treatment of a precancerous condition caused by human papillomavirus
 (HPV) called anal dysplasia (AIN). At the 5th International AIDS Malignancy
 conference, Joel M. Palefsky, M.D., one of the foremost international experts
 in AIN, reported updated results of an open-label Phase II trial in high grade
 anal dysplasia. Data from the first 22 consecutive patients were reported at
 the primary six-month evaluation point where 16 of 22 patients (73%)
 downgraded to low grade dysplasia. These data are consistent with the initial
 reports of this ongoing trial.
     "These data continue to support Stressgen's belief that HspE7 could
 become an important therapeutic option for HPV-related diseases such as anal
 dysplasia. Many patients now require some form of surgery - a potentially
 painful and debilitating procedure. HspE7 could potentially eliminate the need
 for surgery," said John R. Neefe, M.D., Vice President, Clinical Research and
 Regulatory Affairs of Stressgen. To date, no serious adverse events related to
 HspE7 treatment have been observed in the patients reported. Stressgen plans
 to analyze the final data from the completed Phase II AIN trial during the
 third quarter of 2001. The data will then be submitted for initial public
 presentation at an appropriate scientific forum. Stressgen's phase III trial
 in anal dysplasia is actively enrolling patients and is progressing according
 to schedule.
     "At the 5th International AIDS Malignancy Conference, it has become
 increasingly apparent that anal dysplasia is an important public health
 problem, especially among HIV-infected gay men," said Dr. Palefsky, Director
 of the General Clinical Research Center and Professor of the Departments of
 Laboratory Medicine and Stomatology at the University of California, San
 Francisco. "Anal dysplasia is more common than anyone had previously known,
 and it can have serious medical implications if left untreated. We now
 recognize that anal dysplasia affects many men with HIV infection. Worse, the
 incidence of anal cancer, which may be a consequence of anal dysplasia,
 appears to be increasing rapidly in this group. New approaches to the
 treatment of anal dysplasia are badly needed."
     The Company is evaluating the potential of HspE7 as a broad based
 therapeutic for diseases caused by human papillomavirus (HPV). The Company
 currently has a number of clinical trials ongoing, including one Phase III
 trial, and several Phase II trials, and will soon initiate a clinical trial to
 evaluate HspE7 for the treatment of a serious HPV-related disease, recurrent
 respiratory papillomatosis (RRP), for which the FDA recently granted orphan
 drug status. RRP is caused by the same HPV types that cause genital warts.
     HspE7, a recombinant fusion product created with Stressgen's proprietary
 Hsp fusion technology, 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 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 infected cells.
 
     Conference Call
     ---------------
     Stressgen will hold its First Quarter 2001 financial conference call on
 May 3, 2001 at 4:00 p.m. Eastern Time (1:00 p.m. Pacific Time). The call in
 number to access the call is 800/326-6186 in North America. A replay of this
 call will be available from May 3 at 3:00 Pacific Time through May 10, 2001.
 The playback number is: 800/558-5253, reservation number 18670407. To access
 information about the call, please log on to our website, www.stressgen.com.
 
     About Stressgen
     ---------------
     Stressgen is a public 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. In addition to
 targeting HspE7 in HPV-related diseases, the Company has also initiated
 research studies to evaluate its Hsp technology in the treatment of asthma,
 allergy and hepatitis. Stressgen is also an internationally recognized
 supplier of research products for the study of cellular stress, apoptosis,
 oxidative stress and neurobiology, which are used by scientists worldwide.
 
     This press release contains certain "forward-looking" statements within
 the meaning of the Private Securities Litigation Reform Act of 1995. These
 statements are based on the current expectations of our researchers, are
 subject to uncertainty and will require confirmation through additional
 studies. Forward-looking statements contained herein include statements about
 potential side-effects of HspE7, a potential treatment for anal dysplasia, and
 plans to initiate clinical trials which are subject to the ability to
 manufacture HspE7, successfully collaborate with third-parties and obtain
 regulatory approvals. More detailed information about these factors is set
 forth in our Annual Report on Form 10-K as filed with the Securities and
 Exchange Commission. We are not under any obligation to (and expressly
 disclaim any such obligation to) update or alter our forward-looking
 statements, whether as a result of new information, future events or
 otherwise.
 
 SOURCE Stressgen Biotechnologies Corp.