SciClone Initiates Phase 2b Study of SCV-O7 for Treatment of Oral Mucositis

FOSTER CITY, CA, Jan 11 (MARKET WIRE) --
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced the
enrollment of the first patient in the company's phase 2b clinical trial
of SCV-07 for the prevention of oral mucositis (OM) -- a painful,
debilitating, and costly toxicity caused by chemoradiotherapy regimens
used to treat head and neck cancer. The study will examine three doses of
SCV-07, including two higher doses than those used in the company's
recent phase 2a study, to assess the drug's impact on modifying the
course of OM in patients with head and neck cancer. In addition, the
trial will further evaluate SCV-07's safety and tolerability in this
patient population, as well as the role played by specific genetic
profiles on patient response to the treatment.

"We are very pleased with how quickly we have been able to advance the
SCV-07 OM program from completion of our phase 2a trial to the initiation
of this important phase 2b study. This is particularly impressive
considering the fact that our scientific team uniquely designed this
study protocol to leverage those findings which emerged from our phase 2a
trial, including important information related to dosing and efficacy
endpoints," stated Friedhelm Blobel, Ph.D., SciClone's President and
Chief Executive Officer. "We expect that this upcoming study will provide
additional information regarding the potential therapeutic role of SCV-07
in the treatment of OM and, in turn, inform SciClone on the best path for
designing a possible pivotal phase 3 trial."

The multicenter, randomized, double-blind, placebo-controlled study will
enroll approximately 160 subjects who are receiving standard
chemoradiation therapy for treatment of cancers of the head and neck.
Subjects will be randomly assigned to one of the trial's four treatment
arms: placebo and SCV-07 at doses or 0.1 mg/kg, 0.3 mg/kg and 1 mg/kg.
The study's primary efficacy endpoint is the reduction in proportion of
subjects with clinically assessed ulcerative OM (WHO Grade greater than
or equal to 2) at the time that they have received a cumulative radiation
dose of 45 Gy.

The study's secondary endpoints include, among others, incidence and
duration of ulcerative and severe (WHO Grade greater than or equal to 3)
OM; analgesic use and pain assessments, breaks in radiation or
chemotherapy treatment, and unscheduled office or hospital visits.

About Oral Mucositis
OM is a common, painful, debilitating complication
of cancer treatment, and SciClone estimates that total medical costs may
reach around $4.2 billion in the U.S. and $10 billion worldwide in 2010.
OM is a condition in which the sensitive cells lining the mouth and
throat are damaged by cancer treatments such as chemotherapy (with or
without radiation) and become painful mouth sores. Severe OM has been
reported to occur in about 50% of patients who receive chemoradiation for
the prevention of cancers of head and neck (Sonis, Core Evidence, 2009).
Importantly, radiation to the head and neck, especially when it includes
the tissues of the mouth, pharynx and hypopharynx, results in significant
ulcerative OM in greater than 90% of patients (Manas et al, Clinical
Translational Oncology, 2009) and can compromise the patient's ability or
willingness to accept a complete course of therapy. Symptoms can include
painful ulcers in the mouth and throat, redness and swelling of the gums,
dryness and overall soreness in the mouth, and difficulty eating,
swallowing, talking and drinking. In addition to the symptoms of OM and
its impact on quality of life and continued therapy, mucositis can cause
adverse effects on a variety of other health and economic outcomes, such
as a risk of serious infection, the need for parenteral nutrition and
narcotic analgesia, and increased hospitalization and feeding-tube
placement. The National Cancer Institute estimates that 450,000 patients
per year in the U.S. suffer from OM during cancer therapy.

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 and viral
infections, and enhancement of response to vaccines.

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 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. SciClone is evaluating
SCV-07 in a phase 2b trial to modify the course of oral mucositis in
patients with head and neck cancer. 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 or 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
investorrelations@sciclone.com

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