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news.SciClone Pharmaceuticals has enrolled the first patient in its Phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of SCV-07 for prevention of oral mucositis in patients receiving radio-chemotherapy for the treatment of head and neck cancer.
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The first patient was enrolled at the University of Alabama at Birmingham. The study will be conducted at approximately 15 to 20 centers in the US, and will include three treatment cohorts of 20 patients each. Each cohort will receive either placebo, SCV-07 at a dose of 0.02mg/kg, or SCV-07 at a dose of 0.10mg/kg.
The treatment period will be 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. The primary efficacy endpoint is delay of onset of severe oral mucositis.
Cynthia Tuthill, chief scientific officer of SciClone, said: “In preclinical studies, SCV-07 has demonstrated its effectiveness in inhibiting the expression of STAT3, a signaling molecule closely connected with macrophage activation and other immune system parameters.
“Additionally, STAT transcription factors play significant roles in a series of biological processes that are particularly relevant to oral mucositis. We are therefore excited to continue exploring SCV-07’s potential in preventing oral mucositis in addition to carrying out our ongoing clinical investigation of SCV-07 in the treatment of patients with chronic hepatitis C infection.”