Unique genetic markers point to patient response to SCV-07 treatment

February 29, 2016

In addition to the gene expression differences, researchers demonstrated that SCV-07 treatment was associated with significant differences in levels of several immune-related cytokines thought to be important in the development of OM. Samples from patients treated with high dose SCV-07 were analyzed, and it was determined that levels of MIF (p <0.049), MIP-1 beta (p < 0.049) and VEGF (p < 0.015) were found to be significantly higher compared to placebo, whereas levels of IL-1 alpha (p < 0.045) were found to be significantly lower compared to placebo. The patients in the low dose group did not demonstrate these same changes, consistent with the dose effects seen in the clinical study in which the lower dose did not show the same positive response seen in the higher dose treatment arm. The Company believes that the new information regarding cytokine activity may provide additional insight into the fundamental mechanism of action of SCV-07 in the treatment of OM. 

???This phase 2a proof of concept study has provided significant clinical data to support the safety and potential efficacy of SCV-07, as well as the increasingly important area of biomarker identification,??? commented Friedhelm Blobel, Ph.D., SciClone??s President and Chief Executive Officer. ???Importantly, each of these findings will inform our ongoing clinical development of SCV-07 and we look forward to initiating our phase 2b study in patients with OM in late 2010 or early 2011.???

On May 17, 2010, SciClone announced topline results from the Company??s phase 2a proof of concept study of SCV-07 for the prevention of severe OM in patients with advanced head and neck cancer.

Based on the findings from the phase 2a study and completed discussions with the U.S. Food and Drug Administration, SciClone is planning to initiate a phase 2b study in late 2010 or early 2011. As compared to the completed phase 2a trial, the phase 2b study design is expected to include higher doses of SCV-07 and be adequately powered to demonstrate statistical significance. Additionally, researchers will continue to investigate the role of specific genetic profiles on patient response to SCV-07, as well as the potential link between cytokine activity and SCV-07??s sub-cellular mechanism of action.