SCV-07: Development discontinued

SciClone discontinued development of SCV-07 to prevent OM after a pre-planned interim analysis of 85 evaluable patients with head and neck cancer receiving concurrent chemoradiation in a double-blind, U.S. Phase IIb trial showed that the compound would not meet the pre-specified efficacy endpoints vs. placebo. The primary endpoint of the trial was the change from baseline in the proportion of patients with clinically assessed ulcerative OM, defined as WHO grade >=2 at the time the patient has received a cumulative radiation dose of 45 Gy. No safety concerns were identified. The trial was evaluating once-daily 0.1, 0.3 and 1 mg/kg doses of subcutaneous SCV-07 for 7 weeks. SciClone said it is not actively pursuing SCV-07 in other indications, but has conducted preclinical studies of the compound in cancer and could pursue oncology indications in the future. SciClone has exclusive rights to SCV-07 outside of Russia from Verta. ...