SciClone Pharmaceuticals, Inc. 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 Hospital, Professor of Oral Medicine, Harvard School of Dental Medicine, and a leading expert in oral mucositis. "The finding that extends this signal to ulcerative OM is important, as ulceration is the major cause of the morbidity associated with OM."

Based on these study findings, SciClone intends to initiate discussions with the United States Food and Drug Administration regarding the design of a second phase 2 study of SCV-07 for the prevention of OM, which would involve higher doses. SciClone has also submitted a late-breaking abstract on results of this study for the 2010 American Society of Clinical Oncology Annual Meeting.

"We believe these findings support the concept that SCV-07 could provide a clinically meaningful benefit in the prevention of OM for patients with head and neck cancer being treated with chemoradiotherapy by stimulating the immune system through critical signaling pathways," said Israel Rios, MD., Chief Medical Officer and Senior Vice President of SciClone.

The phase 2 multicenter, randomized, double-blind, placebo-controlled, dose ranging proof of concept study was designed to assess the safety and tolerability of SCV-07 as well as provide an indication of efficacy in delaying the onset of severe OM, as assessed by the WHO scale, in patients receiving standard chemoradiation therapy for treatment of cancers of the head and neck. The study was not designed to demonstrate statistical significance and the results are not statistically significant. The study was conducted at 21 centers in the United States and included 59 patients. Patients received either placebo, SCV-07 at a dose of 0.02 mg/kg, or SCV-07 at the higher dose of 0.10 mg/kg. The treatment period was approximately seven weeks depending on the patient's prescribed radiation plan, with a follow-up visit approximately 30 days following the last day of radiation therapy.

For additional information, please visit www.sciclone.com.

Source: web of pharmoutsourcing