Today's Press release:
Stressgen Announces End-of-Phase II Meeting with FDA
- Company Reaffirms HspE7 Development Timeline for RRP -
SAN DIEGO, CA, USA, June 30 /CNW/ - Stressgen Biotechnologies (TSX:SSB) announced that it has achieved another development milestone and held an End-of-Phase II meeting today with the U.S. Food and Drug Administration (FDA) for its lead compound, HspE7. As a result of these discussions, a path forward for the clinical development of HspE7 for recurrent respiratory papillomatosis (RRP) has been identified. Following FDA's recommendation, Stressgen will be submitting a final pivotal clinical trial protocol for a Special Protocol Assessment (SPA). Under a SPA, the sponsor and the FDA formally agree to the details of the study protocol. Following these discussions, Stressgen has reaffirmed its previously announced development and commercialization timeline for the program.
"We are extremely excited about the opportunity to move ahead with the development plans for our lead compound HspE7 in the RRP indication," commented Daniel L. Korpolinski, President and Chief Executive Officer of Stressgen Biotechnologies Corporation. "We look forward to working diligently with the FDA toward expediting the development of the protocols for this compound, which we hope will someday address the unmet medical needs of patients suffering from RRP."
RRP Clinical Trial Results:
Earlier this year, the Company reported that its Phase II clinical trial testing HspE7 in the treatment of patients with RRP met its targeted primary endpoint of lengthening the time between surgeries following treatment with HspE7. These results were highly statistically significant and support Stressgen's plans to begin a pivotal trial and submit a Biologics License Application for RRP as the first indication for the Company's lead product, HspE7, in mid-2007.
The RRP study was a 27 patient single arm, open label trial evaluating the length of time between surgeries following treatment with HspE7; the comparison for each patient was the baseline inter-surgical interval established during the months preceding treatment. In the overall population, the first post-treatment interval increased 93 percent over baseline (p less than 0.02). The median of all post-treatment inter-surgical intervals compared to pretreatment increased to 107.6 days, as compared to 55.3 days at baseline, representing a mean increase of 95 percent. This increase is statistically significant (p less than 0.02). In addition, the median interval of all surgeries reported following treatment suggests that the 27 child patient population experienced 87 fewer surgeries during the first year post treatment. A standard clinical assessment tool, the Derkay-Coltrera Scale Score adjusted for interval between surgeries, is a measure of the growth rate of RRP. The children in this study showed a statistically significant decreased Derkay-Coltera Score by the end of the study (p less than 0.04).
Final data from the Company's Phase II clinical trial with HspE7 to treat RRP was presented as a "late breaker" oral presentation in the plenary session on February 26, 2004 at the 21st International Conference on Papillomavirus held in Mexico City, Mexico.
HspE7 has been granted Orphan and Fast Track status for the lead indication, RRP.
About Fast Track Product Development Program for RRP:
The FDA previously designated HspE7 as a Fast Track Product development program for the treatment of patients suffering from RRP. The Fast Track Product development program of the FDA facilitates the development and expedites the review of designated new drugs and biological products. RRP is a seriously debilitating and sometime life-threatening condition associated with lesions in the larynx and vocal cords caused by infection with HPV. The Fast Track programs are applied to products intended to treat serious or life- threatening conditions that demonstrate the potential to address unmet medical needs.
About Recurrent Respiratory Papillomatosis:
Recurrent respiratory papillomatosis is a seriously debilitating disease predominately caused by the same types of human papillomavirus (HPV) that cause genital warts - types 6 and 11. The papillomas in RRP are found mainly in the larynx and on the vocal chords, but they can spread into the trachea and lungs. Papillomas can be deadly in pediatric RRP due to the small size of the upper airway in children. Death can occur from airway obstruction, cancerous transformation, the overwhelming spread of the disease, or complications of surgical treatments. Currently, the only treatment available for RRP is surgery. There are no approved drugs or immunotherapies. Pediatric patients have on average 4-5 surgeries per year and some children have hundreds of surgeries during their lifetimes.
About Human Papillomavirus:
HPV is one of the most common causes of sexually transmitted diseases in the world. Fifty to 75 percent of sexually active men and women acquire genital HPV infection at some point in their lives. 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 a variety of precancerous conditions, including anal and cervical dysplasia, cervical cancer, anal cancer and can be associated with a number of head and neck cancers.
About Stressgen Biotechnologies Corporation:
Stressgen, a biopharmaceutical company, focuses on the discovery, development and commercialization of innovative immunotherapeutics for the treatment of infectious diseases and cancer. In addition to developing HspE7 for diseases caused by HPV, the Company has also initiated research studies to evaluate stress protein fusions made through its CoVal(TM) technology for the treatment of hepatitis B and herpes simplex and is targeting hepatitis C. 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.
The Company is publicly traded on the TSX Toronto Stock Exchange under the symbol SSB.
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. For more information about CoVal(TM) fusion technology, or Stressgen, please visit the Company at its website located at www.stressgen.com.
This press release contains forward-looking statements, including discussions of developmental and regulatory timelines and applications for CoVal(TM) fusion products. Actual results could differ materially from the implications of these statements due to risks including uncertainties in the regulatory approval process and unfavorable results of clinical trials. Please refer to the detailed discussion of risks included in the Company's Annual Report on Form 10-K for the year ended December 31, 2003 for information about these and other risks.
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For further information: Stressgen Contacts: Donna Slade, Director, Investor Relations, 6055 Lusk Boulevard, 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, jmatterson@stressgen.com
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