SciClone announces topline results from Phase 2 clinical trial of SCV-07 for prevention of oral mucositis
Source: CNNMoney.com Author: press release SciClone Pharmaceuticals, Inc. today announced topline results from the company's phase 2 clinical trial of SCV-07 for the prevention of severe oral mucositis (OM) (World Health Organization, WHO scale, grades 3 to 4) -- a painful, debilitating, and costly toxicity caused by chemoradiotherapy regimens used to treat head and neck cancer. This proof of concept study was intended to provide an estimate of SCV-07's treatment effect and guide further studies of SCV-07 in addressing this serious unmet medical need. Patients receiving the study's higher dose (0.1 mg/kg) of SCV-07 showed a trend towards delay to onset of severe OM, the study's primary endpoint. Patients in the low dose treatment arm (0.02 mg/kg) appeared to do worse than placebo, suggesting that the treatment effect is sensitive to dose. Additionally, SCV-07 was safe and well tolerated with no drug-related serious adverse events reported, indicating that there is potential to administer higher doses of SCV-07 in future clinical studies. Additional data analysis showed a more pronounced clinical benefit for patients in the high dose treatment arm when evaluating the delay to onset of ulcerative OM (WHO scale, grades 2 to 4), an expanded measure of OM. In this analysis, the low dose treatment arm appeared similar or slightly better than placebo. "We are encouraged that the trial provides an indication of a biological signal, in the high dose arm, for the pre-specified primary endpoint of the study," said Stephen T. Sonis, DMD, DMSc, Senior Physician, Brigham and Women's [...]