SAN DIEGO, CA, April 19 /PRNewswire-FirstCall/ - Stressgen Biotechnologies Corporation today provided a corporate update and details regarding the next phase of clinical development of HspE7, a novel investigational therapeutic vaccine for the treatment of serious human papillomavirus (HPV)-related diseases. The Company had originally planned to begin a Phase III study in the first quarter of this year with the original HspE7 formulation. However, the Company announced that it will now be focusing its resources on the development of a more potent, reformulated version of HspE7.
"Over the past twelve months, we have streamlined our operations, leveraged our non-core assets to fund our operations and re-invigorated the Company with new shareholders, new management and new members of our Board of Directors. In essence, we have strengthened all of the critical areas of the Company," stated Gregory M. McKee, President and Chief Executive Officer of Stressgen. "And now, following the completion of an in-depth product evaluation, we have determined that it is in the best interest of our shareholders to dedicate our resources towards the development of a reformulated HspE7 compound for the treatment of diseases caused by HPV."
"Impressive preclinical data have been generated around several reformulated versions of HspE7 combined with low concentrations of an adjuvant," continued Mr. McKee. "These data indicate dramatically increased potency, which we believe provides us with both a clearer and lower-risk commercialization pathway and may provide expanded marketing opportunities for the compound, factors that we believe outweigh any delay in the clinical development pathway of HspE7."
Reformulated HspE7 Twelve-month Development Strategy
Over the next year, Stressgen intends to focus its resources on the following goals:
- Completion of acute safety, toxicology and pharmacodynamic studies
of the reformulated drug candidate, seeking presentation and/or
publication of these data.
- Completion of preclinical and clinical regulatory packages and
submission to the U.S. Food and Drug Administration (FDA).
- Initiation of a 400+ patient, three-arm, Phase I/II study in
patients with genital warts or high-grade cervical dysplasia that
will include placebo, adjuvant and HspE7.
- Evaluation and design of a Phase II//III study in patients with
Recurrent Respiratory Papillomatosis (RRP), a trial that could
potentially be used as a single registration trial, given the orphan
indication and high unmet medical need.
Peter Emtage, Ph.D., recently appointed as Stressgen's Vice President of Research and Development, commented on the market opportunities for the Stressgen product candidate portfolio: "I believe Stressgen is well positioned for future commercial success as one of the only companies focused on the development of therapeutic treatments for patients with HPV-related diseases. There are nearly 20 million patients currently in North America already infected with HPV - none of whom will benefit from vaccines designed to prevent HPV infection. In addition, there are 5.5 million individuals newly infected each year, and even if prophylactic vaccines are utilized, it will be decades before these products have significant impact on the rate of infection."
Through recent restructurings and careful spending, Stressgen has been able to decrease its core burn rate to approximately C$650,000 per month and expects this base spending rate to continue for the next year. In addition, the Company estimates that the two clinical trials described above would each cost approximately US$5,000,000.
Stressgen will hold a conference call on Thursday, April 20, 2006, at 10:00 am Eastern Time (7:00 am Pacific Time).
Audio Conference Numbers:
Call-in number to access the call: If you are in the U.S. or Canada call: 800 274-4979. The conference code is: 8095549. If you are International call: 706 643-3435.
Replay of Audio Portion:
A replay of this call will be available at 11:00 am Eastern Time from April 20, 2006 through 11:00 pm Eastern Time on April 27, 2006. The playback number: 800 642-1687 (North America) or 706 645-9291 (International), Conference ID: 8095549.
Prior to the live call please register for the event: http://audioevent.mshow.com/296461
If you wish to access the call via the Internet: mms://winaudio.mshow.com/296461.asf
The archive will be available shortly after completion of the live call and last for 30 days:
Show Number: 296461
About Stressgen Biotechnologies Corporation:
Stressgen is developing innovative therapeutics for the treatment of viral infections, with a focus on diseases caused by the human papillomavirus (HPV). The corporation is publicly traded on the Toronto Stock Exchange under the symbol SSB. For more information about Stressgen, please visit the website located at www.stressgen.com.
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 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.
This press release contains forward-looking statements regarding our corporate strategies, and development of therapeutics for the treatment of viral infections. Actual results could be materially different from those implied by these forward-looking statements due to factors over which we have limited control, including but not limited to our ability to continue as a going concern, our ability to enter into corporate partnering relationships (and the effects and terms of those relationships), our ability to raise additional funds, the outcomes from clinical trials, our ability to meet regulatory approval requirements difficulties inherent in the manufacture of commercial-grade drug supplies, and the risk that even if successfully developed, our products may not be commercially successful. Please refer to our filings with Canadian securities regulators for more information on these and other applicable risks. We assume no obligation and expressly disclaim any duty to update any forward-looking statement to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.
Gregory McKee Donna Slade
President and Chief Executive Officer Director, Investor Relations
6055 Lusk Boulevard 6055 Lusk Boulevard
San Diego, CA USA 92121 San Diego, CA USA 92121
Tel: 858/202-4900 Tel: 858/202-4900
Dir: 858/202-4940 Fax: 858/450-6849
Stressgen Biotechnologies Corp.