BioCentury
ARTICLE | Clinical News

SciClone discontinues oral mucositis therapy

March 3, 2012 12:39 AM UTC

SciClone Pharmaceuticals Inc. (NASDAQ:SCLN) discontinued development of SCV-07 to prevent oral mucositis (OM) after an interim analysis showed the compound would not meet the pre-specified efficacy endpoints vs. placebo in a Phase IIb trial. The interim analysis included 85 evaluable patients with head and neck cancer receiving concurrent chemoradiation. The primary endpoint of the trial was the change from baseline in the proportion of patients with clinically assessed ulcerative OM. No safety concerns were identified. The product is a synthetic peptide immune stimulant that acts via inhibition of signal transducer and activator of transcription 3 (STAT3) signaling.

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 cancer indications in the future. SciClone has exclusive rights to SCV-07 outside of Russia from Verta Ltd. (St. Petersburg, Russia). ...