Results From Phase 2A Clinical Trial Using SCV-07 As Monotherapy In Patients With Chronic Hepatitis C Infection

Main Category: Liver Disease / Hepatitis
Also Included In: Clinical Trials / Drug Trials
Article Date: 23 Sep 2008 - 5:00 PDT

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SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) announced promising results from its proof-of-concept phase 2 clinical trial using its proprietary, immunomodulatory compound SCV-07 as a sole agent administered to patients chronically infected with the hepatitis C virus (HCV). The trial was designed to evaluate the effect of SCV-07 on hepatitis C viral load, as well as on other measures of immune response. SCV-07 demonstrated activity in some treated patients in the higher dosage groups, and the decrease in viral load in these patients was accompanied by an increase in an immunological biomarker which is usually correlated with response against HCV. Additionally, SCV-07 was shown to be generally safe and well-tolerated with no dose limiting toxicities or serious adverse events reported.

"In this study, SCV-07 demonstrated encouraging antiviral activity in patients who were previous relapsers to treatment," said Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone. "This is particularly exciting as patients were treated with only 7 days of monotherapy. Based on the promising outcome of this trial, SciClone plans to investigate further SCV-07's potential to prime the human immune system against HCV and plans to discuss with the FDA the initiation of a follow-up phase 2B trial. The follow-up trial may also be used to determine whether SCV-07 is capable of replacing or improving the response to current standard of care treatment. We are also pleased by the lack of side effects seen during treatment with SCV-07."

This randomized, placebo-controlled trial enrolled 34 patients infected with the difficult to treat genotype 1 strain of HCV, who had previously responded to treatment with interferon alpha and ribavirin but subsequently relapsed. Patients were randomized into three cohorts of escalating doses, and received daily subcutaneous injections of SCV-07 or placebo. After completing seven days of therapy, all patients were monitored for a further 7 days and patients in the highest dosage group were monitored for 30 days following end of treatment.

The primary objective of the trial was to assess the antiviral effect of SCV-07 on hepatitis C viral load and the pharmacodynamic effect as assessed by various biomarkers. In chronically infected patients, without treatment, variations in the amount of circulating HCV typically do not vary by more than 0.3 log. In this trial, reductions of greater than 0.6 log were seen in more than 10% of treated patients.

"SCV-07 has been shown to bind to macrophages and inhibit STAT-3 dependent responses, leading to stimulation of the Th1 immune response," said Israel Rios, M.D., Senior Vice President and Chief Medical Officer of SciClone. "A Th1 immune response is typically correlated with improved response in HCV patients. Additionally, neopterin levels are usually increased in connection with the stimulation of the Th1 immune response. In this trial, we have seen increased neopterin levels accompanying reduction in viral loads."

About SCV-07

SciClone's proprietary drug candidate SCV-07 (gamma-D-glutamyl-L-tryptophan) is a synthetic peptide with proven immune stimulating effects. SCV-07 has shown efficacy in treating various viral and bacterial infections. SCV-07 specifically stimulates the immune system through its effects on T-helper 1 cells, which are essential for clearance of viral infections. In June 2007, SciClone reported that SCV-07 also inhibits melanoma tumor growth, a cancer know to be sensitive to immune modulation, in an animal model study. Additional preclinical studies with SCV-07 are ongoing. For more information about SCV-07, please refer to the SciClone press release dated June 27, 2007.

About Hepatitis C Virus

HCV is a viral disease which attacks the liver and can lead to cirrhosis of the liver, liver cancer, and death. According to the Centers for Disease Control and Prevention, approximately 3.2 million individuals in the United States are chronically infected with HCV. Approximately 75% of these chronically infected carriers are infected with the difficult to treat genotype 1 strain of the virus. Unfortunately, currently approved therapy, including the immunotherapy interferon alpha with or without the antiviral drug ribavirin, has significant side effects and is ineffective in treating most patients infected with HCV genotype 1.

About SciClone

SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN(R) is currently being evaluated in a late-stage clinical trial for the treatment of hepatitis C, and successfully completed a phase 2 clinical trial in malignant melanoma. ZADAXIN is approved for sale in select markets internationally, most notably in China where SciClone has an established sales and marketing operation. A key part of SciClone's strategy is to leverage its advantage and broaden its portfolio in the rapidly growing Chinese market by in-licensing or acquiring the marketing rights to other products, such as DC BeadTM. SciClone's other clinical-stage drug development candidates are RP101 for the treatment of pancreatic cancer and SCV-07 for the treatment of hepatitis C. For more information about SciClone, visit http://www.sciclone.com.

This press release contains forward-looking statements including our statement regarding timing and expectations for an SCV-07 Phase 2B clinical trial. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These risks and uncertainties include our forward-looking statements because of the inherent uncertainties, including in the timing of clinical trial events such as including patient enrollment, requirements of, and future actions of, the U.S. Food and Drug Administration, the fact that experimental data, and clinical results derived from studies with animals or a limited group of patients, and as well as comparisons with other clinical trials may not be predictive of the results of larger studies and, therefore, such experimental or clinical data are not necessarily predictive indicative of the efficacy or safety or the results of larger studies and clinical trials. Please also refer to the other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission. All forward-looking statements are based on information currently available to SciClone, and SciClone assumes no obligation to update any such forward-looking statements.

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