SciClone Announces Topline Results From Phase 2b Clinical Trial of SCV-07 for Treatment of Chronic Hepatitis C
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FOSTER CITY, CA, Dec 15 (MARKET WIRE) --
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced topline
results from the Company's phase 2b clinical trial of SCV-07 for the
treatment of hepatitis C (HCV). The study evaluated the safety and
immunomodulatory effects of SCV-07 as a monotherapy and in combination
with ribavirin in relapsed HCV patients. Study data demonstrated SCV-07
to be safe and well-tolerated at both administered doses. Topline results
showed a clear biological signal from SCV-07 but did not meet the study's
primary efficacy endpoint of a 2 log reduction in viral load from
baseline level. A secondary measure of efficacy, defined as a reduction
in viral load of greater than 0.5 log from baseline level, was seen in
38.5% of the low-dose patients (5/13) and in 44.4% of the high-dose
patients (8/18). Additionally, while no patients in the low-dose group
achieved greater than a 1 log reduction, 3 of the high-dose patients
achieved greater than a 1 log reduction in viral load. This proof of
concept study was designed to provide an estimate of SCV-07's treatment
effect in relapsed HCV patients and guide further studies of SCV-07 in
addressing this chronic infection.
"Although the data showed an interesting biological signal, due to the
rapidly changing landscape of effective treatments which increase the
complexity and risks of developing drugs in chronic HCV, we have decided
not to continue development in this indication. On another front, we
continue to be excited about the potential for SCV-07 in the prevention
of oral mucositis in patients with head and neck cancer and the
initiation of our phase 2b study, which should begin by early 2011,"
stated Friedhelm Blobel, Ph.D., President and Chief Executive Officer of
SciClone. "Our primary focus remains on rapidly growing our commercially
successful specialty pharmaceutical business in China and other key
emerging markets to increase profitability and generate cash for our
shareholders."
Study Design
The phase 2b multicenter, multi-dose, open-label study was
designed to evaluate the safety and immunomodulatory effects of SCV-07 as
a monotherapy or in combination with ribavirin in non-cirrhotic patients
with genotype 1 chronic HCV who have relapsed after at least 44 weeks of
treatment with pegylated interferon and ribavirin. The study, which also
monitored biomarkers of immune activation and HCV viral load dynamics,
included two treatment cohorts of 20 patients each who received SCV-07 at
a dose of either 0.1 mg/kg or 1.0 mg/kg. The eight week treatment period
included four weeks of SCV-07 monotherapy followed by four weeks of
SCV-07 in combination with ribavirin. The trial also included three
follow-up visits within seven weeks after the completion of treatment.
About SCV-07
SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule
which appears to stimulate the immune system through inhibition of STAT3
signaling and the resulting effects on T-helper 1 cells. SCV-07 has been
shown to be efficacious in animal models of immune-sensitive diseases,
including prevention of oral mucositis, treatment of cancer, viral
infections, and enhancement of response to vaccines.
Additionally, SciClone is currently planning to initiate a phase 2b study
of SCV-07 for the prevention of oral mucositis by early 2011. As compared
to the company's recently 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 expect to 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.
SCV-07 is protected by composition of matter patents as well as multiple
method of treatment patents. SciClone has exclusive worldwide rights to
SCV-07 outside of Russia, where the molecule has recently been approved
for stimulation of depressed immune systems.
About SciClone
SciClone Pharmaceuticals (NASDAQ: SCLN) is a
revenue-generating, China-centric, specialty pharmaceutical company with
a substantial international business and a product portfolio of novel
therapies for cancer and infectious diseases. The Company is focused on
continuing sales growth and executing a clinical development strategy
with prudently managed costs. ZADAXIN(R) (thymalfasin) is approved in
over 30 countries for the treatment of hepatitis B (HBV) and hepatitis C
(HCV), certain cancers, and as a vaccine adjuvant. In addition to further
studying thymalfasin's use as a vaccine enhancer, SciClone is planning to
evaluate SCV-07 in a phase 2b trial to modify the course of oral
mucositis in patients with head and neck cancer; and recently completed a
phase 2b trial of SCV-07 for the treatment of HCV. The Company also has
exclusive commercialization and distribution rights in China to a novel
treatment for advanced liver cancer, DC Bead(R), currently under review
by regulatory agencies in that country. Additionally, SciClone owns
exclusive commercialization and distribution rights to the anti-nausea
drug ondansetron RapidFilm(R) in China, including Hong Kong and Macau,
and Vietnam. The Company intends to seek regulatory approval for the
product, commonly used to treat and prevent nausea and vomiting caused by
chemotherapy, radiotherapy, and surgery, in these markets. For additional
information, please visit www.sciclone.com.
Forward-looking statements
The information in this press release
contains forward-looking statements, including our expectations and
beliefs regarding the timing and results of our clinical trials. 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 regarding our commercial and
development objectives because of uncertainties, including future sales,
product pricing, the timing of clinical trial events such as 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,
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.
DC Bead is a registered trademark of Biocompatibles UK Limited.
RapidFilm is a registered trademark of Labtec Gesellschaft fuer
technologische Forschung und Entwicklung mbH.
Corporate Contacts
Gary Titus
Chief Financial Officer
650.358.3456
gtitus@sciclone.com
Ana Kapor
Investors/Media
650.350.4825
akapor@sciclone.com
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