You are here
Positive Results Presented for Phase II Trial of Recurrent Respiratory Papillomatosis in Children
CHICAGO, IL, Sept. 16 /PRNewswire-FirstCall/ -- Stressgen Biotechnologies Corporation (TSX:SSB) today presented interim data from its Phase II trial with HspE7 in recurrent respiratory papillomatosis (RRP), a seriously debilitating and sometimes life-threatening condition for children, at the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy in Chicago, Illinois. These data will be available on the Company's website at http://www.stressgen.com/.
The primary endpoint of the Phase II trial evaluated the interval between surgeries following treatment with HspE7 compared to the pretreatment surgical interval. The increase in the first post-treatment intersurgical interval is statistically significant (p less than 0.01); likewise, the increase in the median of all post-treatment intervals is statistically significant (p less than 0.05). For the overall population, the first post-treatment interval increased 78.6 percent over the pretreatment interval, resulting in fewer surgeries for these patients. Almost half of these children were rated "severe" by a laryngeal scale score or by having papillomas in their lungs (lung involvement is the most serious manifestation of RRP).
The annualized surgical rate was calculated, along with the change in the patient's surgical rate after treatment with HspE7. These data indicated that the annual number of surgeries RRP patients would require is reduced by 37% with HspE7 therapy. This reduction in the number of surgeries after treatment is highly statistically significant (p less than .0001). It is projected that more than 50 surgeries will have been avoided during the year after treatment with HspE7 among the patients who experienced at least one surgery reduction compared with the pretreatment period.
Additional results from this Phase II trial, including follow-up data on approximately 50 percent of the patients who have completed the 60-week study, will be presented at the Society for Ear, Nose and Throat Advances in Children (SENTAC) meeting in New Orleans on October 30-November 1, 2003.
"We're very excited about the positive effect of HspE7 in treating these seriously ill children," said John R. Neefe, M.D., Senior Vice President of Clinical Development. "Treatment with HspE7 reduced the number of times these children undergo a surgical excision under anesthesia, an emotionally draining ordeal. Remarkably, surgery has not been required in some patients since treatment with HspE7, and in most children with improvement, their improvement is being sustained."
Whereas spontaneous doubling of the intersurgical intervals is unexpected in pediatric RRP, 30 percent of these patients achieved a doubling of the first intersurgical interval after therapy. Additional patients, who did not have an immediate improvement in surgical interval, have doubled their interval with continued follow up. To date, 41 percent of patients have achieved doubled intervals after treatment. The expansion of the list of improved patients with the passage of additional months is consistent with data seen in previous HspE7 clinical trials in patients with genital warts and anal dysplasia.
HspE7 was well tolerated in this pediatric population. The most common side effect was mild to moderate reaction at the site of injection.
About Recurrent Respiratory Papillomatosis:
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:
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.