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Monday, 05/17/2010 9:14:15 AM

Monday, May 17, 2010 9:14:15 AM

Post# of 122
3:09AM SciClone Pharma provides clinical program update for SCV-07 for prevention of oral mucositis in patients with advanced head and neck cancer (SCLN) 3.90 : Co announces further topline results from the their phase 2 proof of concept study of SCV-07 for the prevention of severe oral mucositis in patients with advanced head and neck cancer. High dose SCV-07 The incidence of severe OM after 5 weeks of chemoradiation was 30% lower in the patients in the high dose treatment arm (0.1 mg/kg; 17 patients) compared to the 20 patients who received placebo (29% vs. 42%). A post hoc data analysis of ulcerative mucositis, a major cause of morbidity associated with OM, was also conducted. The high dose of SCV-07 prevented the onset of any ulcerative mucositis in 24% of patients at doses of radiation up to 50Gy (after approx 5 weeks of treatment) while 100% of patients in the placebo group suffered from ulcerative mucositis at 35Gy (after approx 3.5 weeks of treatment). Supportive of these findings, the high dose SCV-07 group also showed improvement over placebo for exploratory endpoints, including the use of gastric tube feedings, unplanned office or emergency room visits, and breaks in planned course of radiation therapy of one week or longer.


surf's up......crikey