Stressgen Receives FDA Fast Track Designation for HspE7
Thursday December 4, 7:59 am ET
-- Lead Product Receives Designation for Patients with Recurrent Respiratory Papillomatosis --
VICTORIA, BC and SAN DIEGO, CA, Dec. 4 /CNW/ - Stressgen Biotechnologies Corporation (TSX:SSB - News) announced today that the U.S. Food and Drug Administration (FDA) has designated HspE7, the Company's lead immunotherapeutic for human papillomavirus (HPV)-related diseases, as a Fast Track Product development program for the treatment of patients suffering from recurrent respiratory papillomatosis (RRP). The Fast Track Product development programs of the FDA facilitate the development and expedite 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.
"The designation of HspE7 as a Fast Track Product development program for RRP could expedite our timelines in getting HspE7 into the market as quickly as possible," said Daniel L. Korpolinski, President and Chief Executive Officer of Stressgen.
With the Fast Track Development program, Stressgen can take advantage of a number of programs at FDA to facilitate an efficient regulatory review. In addition, HspE7 may now be considered for priority review and accelerated approval. Sponsors of Fast Track Development program products are also eligible to submit "rolling BLAs" enabling the FDA to commence review of portions of the application before the Sponsor submits a complete application.
The FDA designated HspE7 for a Fast Track Development program after review of the interim results of the Phase II study in which pediatric patients with RRP demonstrated a significant (p less than 0.01) increase of 79 percent in the first post-treatment inter-surgical interval (compared to the median pre-treatment inter-surgical interval) after they were treated with three injections of HspE7. There was also a significant increase in the median of all post-treatment inter-surgical intervals, resulting in fewer surgeries (currently the most prevalent therapeutic intervention) for these children during the first year post-treatment.
About Recurrent Respiratory Papillomatosis:
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Recurrent respiratory papillomatosis is a seriously debilitating disease 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:
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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, 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. |
