FOSTER CITY, CA, Nov 23 (MARKET WIRE) --
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that
patient enrollment is complete ahead of schedule for its phase 2 trial of
SCV-07 -- a small molecule synthetic peptide with immunomodulating
properties -- for the treatment of severe oral mucositis (OM) in patients
with head and neck cancer. Topline results of the oral mucositis trial
are expected to be announced in the first half of 2010.
"Oral mucositis is a painful, debilitating side effect of radiation
therapy used for the treatment of head and neck cancers," said Stephen T.
Sonis, DMD, DMSc, Brigham and Women's Hospital, Boston, MA. "Despite the
fact that oral mucositis occurs in the vast majority of patients in this
population, there are currently no effective treatment options available.
We are encouraged by previous preclinical data which suggest that SCV-07
may be safe and effective in delaying the onset and reducing the severity
of oral mucositis and we look forward to the results of the current
trial."
SciClone's multicenter, randomized, double-blind, placebo-controlled, dose
ranging study is designed to assess the safety and efficacy of SCV-07 for
the delay to onset and severity of oral mucositis in patients receiving
standard chemoradiation therapy for treatment of cancers of the head and
neck. SciClone is encouraged by the rate of enrollment, which began 11
months ago.
"SCV-07 appears to work through inhibition of the STAT3 signaling pathway.
Studies have shown that over-expression of STAT3 can dampen natural immune
responses, and increases in STAT3 have been correlated with epithelial
cell damage after radiation," said Cynthia W. Tuthill, Ph.D., Chief
Scientific Officer of SciClone. "SCV-07's safety profile and its ability
to stimulate the immune system make it a promising treatment,
particularly for patients undergoing complicated chemotherapy or
radiation treatments due to their malignancies."
The study is being conducted at 21 centers in the United States, and
includes 20 patients in each of the three treatment cohorts. Each cohort
receives placebo, SCV-07 at a dose of 0.02 mg/kg, or SCV-07 at a dose of
0.10 mg/kg. The treatment period is approximately seven weeks depending on
the patient's prescribed radiation plan, with a follow-up visit
approximately 30 days following the last day of radiation therapy. All the
patients have been treated with a standard cisplatin regimen in addition
to radiation therapy. The primary efficacy endpoint is delay of onset and
severity of severe OM.
For more information on SciClone's phase 2 trial of SCV-07 in the delay to
onset and severity of oral mucositis, please visit www.clinicaltrials.gov.
About SCV-07
SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule which
stimulates 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
viral infections and cancers, and in the enhancement of response to
vaccines.
Additionally, SciClone is currently running a multicenter, multidose, open
label phase 2 clinical trial of SCV-07 as a monotherapy and in combination
with ribavirin to treat patients infected with hepatitis C virus, who have
relapsed after the last treatment. SCV-07 has shown a good safety profile
in several early stage clinical trials in healthy volunteers and subjects
with HCV infection at various doses. SciClone expects to complete
enrollment in this study in the first half of 2010 and provide initial
results in the second half of 2010.
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 Oral Mucositis
Oral mucositis is a painful and debilitating side effect of many of the
drug or radiation regimens used to treat cancer. Oral mucositis 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. Oral mucositis has been
reported to occur in about 40% of patients who receive chemoradiation
(Sonis et al., Nature, 2004). Radiation to the head and neck, especially
when it includes the tissues of the mouth, pharynx and hypopharynx,
almost always results in significant oral mucositis. 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. The National Cancer Institute estimates
that 400,000 patients in the U.S. suffer from oral mucositis during
cancer therapy.
About SciClone
SciClone Pharmaceuticals (NASDAQ: SCLN) is a profit-driven, global
specialty pharmaceutical company with a substantial international business
and a product portfolio of novel therapies for cancer and infectious
diseases. SciClone is focused on continuing international sales growth, a
cost-containing clinical development strategy, and overall expense
management. ZADAXIN(R) (thymalfasin or thymosin alpha 1) is sold in over
30 countries for the treatment of hepatitis B (HBV) and hepatitis C (HCV),
certain cancers and as a vaccine adjuvant. SciClone's pipeline of drug
candidates includes thymalfasin, in preclinical studies as an enhancer of
H1N1 flu vaccines; thymalfasin for stage IV melanoma, for which SciClone
has reached agreement with the FDA on the design of a phase 3 trial;
SCV-07 in a phase 2 trial for the delay of onset of severe oral mucositis
in patients receiving chemoradiation therapy for the treatment of cancers
of the head and neck; and SCV-07 in a phase 2 trial for the treatment of
HCV. SciClone has exclusive commercialization and distribution rights to
DC Bead(TM) in China, where the product is under regulatory review. The
Company also has exclusive commercialization and distribution rights to
the anti-nausea drug ondansetron RapidFilm(TM) in China and Vietnam, for
which it will seeking regulatory approval. For additional information,
please visit www.sciclone.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding
development objectives and timing expectations. You are urged to consider
statements that include the words "may," "will," "would," "could,"
"should," "might," "believes," "estimates," "projects," "potential,"
"expects," "potential," "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 ability to complete clinical trials of SCV-07 and for such
trials to demonstrate SCV-07 having a significant therapeutic effect for
treatment of oral mucositis without adverse side effects. Please also
refer to other risks and uncertainties described in SciClone's filings
with the SEC. 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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