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
sciclone.
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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