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SciClone to Inform Development of Oral Mucositis Drug with Response Gene Clusters

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Originally published Oct. 5.

SciClone Pharmaceuticals last week announced that it has identified two "unique gene clusters" associated with study subjects who responded to an investigational treatment in the company's pipeline called SCV-07.

"The discovery of these gene clusters may assist in providing the framework for effectively identifying those patients most likely to respond to SCV-07 in future clinical trials based on their individual genomic profile or gene signature," the company said in a statement. The company reported the findings last week during the American Association for Cancer Research's conference on Molecular Diagnostics in Cancer Therapeutic Development in Denver, Colo.

SciClone is developing SCV-07 for the prevention of severe oral mucositis in head and neck cancer patients. As part of a recently completed Phase IIa study, SciClone researchers collected and analyzed RNA samples from patients before and after they received treatment with the drug.

"Results from this gene expression analysis demonstrated the strong association of two specific gene clusters with patient response to SCV-07," the company said. "Consistent with SCV-07's activity as a modulator of the immune system, these clusters included genes associated with G-protein coupled receptors, signal transducers, glycoproteins and membrane proteins."

Previously reported analysis from the Phase IIa study suggests a particularly favorable response in patients receiving a high dose of SCV-07, which, combined with the molecular findings, sheds more light on the subset of patients that is most likely to benefit from the drug, the company said.

SciClone also reported that SCV-07 treatment was linked to significant differences in levels of several immune-related cytokines that may 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, MIP-1 beta, and VEGF were found to be significantly higher compared to placebo, whereas levels of IL-1 alpha were found to be significantly lower compared to placebo," SciClone reported.

However, while the cytokine changes appeared in the high-dose arm, study participants in the low-dose group did not experience similar changes. "The new information regarding cytokine activity may provide additional insight into the fundamental mechanism of action of SCV-07 in the treatment of OM," SciClone stated.

According to SciClone CEO Friedhelm Blobel, these findings will inform the company's ongoing development of SCV-07. SciClone plans to initiate a Phase IIb study in patients with OM in late 2010 or early 2011

After discussing the Phase IIa results with the US Food and Drug Administration, SciClone is planning a Phase IIB study that will feature higher doses of the drug and be powered to show statistical significance. Additionally, the company said it will continue to investigate the role of specific gene profiles on patients' responses to SCV-07, and the link between cytokine activity and the drug's sub-cellular mechanism of action.

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