SciClone completes enrollment in Phase II oral mucositis trial
SCLN | Quote | Chart | News | PowerRating -- SciClone Pharmaceuticals has reported that patient enrollment is complete ahead of schedule for its Phase II trial of SCV-07, a small molecule synthetic peptide with immunomodulating properties, for the treatment of severe oral mucositis in patients with head and neck cancer.
SciClone's multicenter, randomized, double-blind, placebo-controlled, dose-ranging study is designed to assess the safety and efficacy of SCV-07 for the delay to onset and severity of oral mucositis in patients receiving standard chemoradiation therapy for treatment of cancers of the head and neck. SciClone said that it is encouraged by the rate of enrollment, which began 11 months ago.
The study is being conducted at 21 centers in the US, and includes 20 patients in each of the three treatment cohorts. Each cohort receives placebo, SCV-07 at a dose of 0.02mg/kg, or SCV-07 at a dose of 0.10mg/kg. The treatment period is 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.
All the patients have been treated with a standard cisplatin regimen in addition to radiation therapy. The primary efficacy endpoint is delay of onset and severity of severe oral mucositis. Topline results of the oral mucositis trial are expected to be announced in the first half of 2010.
Cynthia Tuthill, chief scientific officer of SciClone, said: "SCV-07 appears to work through inhibition of the STAT3 signaling pathway. Studies have shown that over-expression of STAT3 can dampen natural immune responses, and increases in STAT3 have been correlated with epithelial cell damage after radiation. SCV-07's safety profile and its ability to stimulate the immune system make it a promising treatment, particularly for patients undergoing complicated chemotherapy or radiation treatments due to their malignancies."
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