SciClone
Provides Promising Results from Its Phase 2A Clinical Trial Using SCV-07 as a
Monotherapy in Patients with Genotype 1 Chronic Hepatitis C Infection Foster
City, CA -- September 22, 2008 -- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN)
today 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, PhD, President and Chief Executive Officer of SciClone.
"This is particularly exciting as patients were treated with only seven 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 seven 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, MD,
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.
About SciClone
SciClone
Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics
to treat life-threatening diseases. SciClone's lead product Zadaxin 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 Bead. 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
Pharmaceuticals, visit www.sciclone.com.
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