FOSTER CITY, CA and ROME--(Marketwire - January 12, 2010) - SciClone Pharmaceuticals, Inc.
(NASDAQ: SCLN) and its partner Sigma-Tau S.p.A. have received initial
topline results in a clinical study evaluating the potential of ZADAXIN®
(thymalfasin) to enhance immune response to the MF59 adjuvanted H1N1
influenza monovalent vaccine, Focetria™ from Novartis. According to
investigators, ZADAXIN treatment given with the H1N1 vaccine led to a
highly statistically significant (p value < 0.01) increase in the
percentage of subjects who seroconverted at 21 days after vaccination, when
compared to those who received the H1N1 vaccine alone. Seroconversion is
defined as a four fold or greater change in titers from baseline.
The randomized, three-arm open label study has a planned duration of 6
months and hence is still ongoing. It is being conducted in patients with
end-stage renal disease who are on chronic dialysis. One cohort of patients
received the H1N1 vaccine only, while the other two groups received either
two 3.2 mg injections of thymalfasin (one seven days prior to vaccination
and the second on the day of vaccination with Focetria), or two 6.4 mg
injections of thymalfasin (one seven days prior to vaccination and the
second on the day of vaccination with Focetria). Dosing regimens were based
on preclinical results obtained in ferret and mouse models conducted in
Europe and the U.S. earlier this year.
This ongoing study is designed to evaluate efficacy based on the proportion
of patients achieving seroconversion -- a significant rise in specific
antibody titers against H1N1 influenza. According to investigators, at 21
days following vaccination, 89% of patients in the low-dose ZADAXIN arm
achieved seroconversion as did 88% of patients in the high-dose ZADAXIN
arm, compared to only 56% of patients in the vaccine-only arm of the study.
All patients are being followed for six months, to measure the durability
of the protective titers, the second key parameter for the assessment of
the immunogenicity of a vaccination. A higher seroconversion rate is
indicative of the robustness of the immune response and may lead to more
"We believe the rapid achievement of full enrollment in this study
indicates the need for safe and effective vaccine enhancers to help protect
immune compromised and elderly patients from H1N1 influenza," said Prof
Trevor Jones, Group R&D Director, Sigma-Tau. "Given the complexities in
treating those with compromised or weakened immune systems, we believe
these are the patients most in need of protection from life-threatening
virus infections such as H1N1."
"We are encouraged by the results of the study which, for the first time,
used less frequent injections of ZADAXIN at the higher dose formulation,"
said Friedhelm Blobel, Ph.D., SciClone's President and Chief Executive
Officer. "We hope that this pilot study will be completed successfully and
that we can proceed thereafter with applications for regulatory approval
regarding the use of ZADAXIN as an enhancer for vaccinations for H1N1
influenza using a one or two shot dosing regime. We have obtained
regulatory approval for ZADAXIN for use as an adjuvant for regular
influenza in more than 10 countries using multiple injections."
ZADAXIN has an excellent safety profile, with a long track record of
patient use. Approximately 100,000 patients worldwide have used ZADAXIN in
both clinical and commercial settings, alone and in combination with
various antiviral and anticancer drugs.
About thymalfasin (ZADAXIN)
ZADAXIN, scientifically referred to as thymalfasin or thymosin alpha 1, is
SciClone's synthetic preparation of thymalfasin, a peptide produced by the
thymus gland which circulates in the blood naturally and is instrumental in
immune responses. Published scientific and clinical studies have shown that
thymalfasin helps stimulate and direct the body's immune system to improve
response to vaccines, and to eradicate infectious diseases like HCV and
HBV, as well as certain cancers.
Within the immune system, thymalfasin stimulates stem cell differentiation
and increases production of antibodies and disease-fighting T cells,
including CD4, CD8, and natural killer cells, while simultaneously slowing
the breakdown and removal of these T cells. The increase in production of
antibodies after thymalfasin treatment leads to an increase in response to
vaccines, providing enhanced protection against infection; the increases in
T-helper cells allows the immune system to tag and identify invasive agents
and cancerous cells for removal.
In late 2008, SciClone and the FDA reached agreement in form of a Special
Protocol Assessment on the design of a phase 3 registration trial for
thymalfasin as a potential treatment for stage IV melanoma. Thymalfasin's
potential beneficial role in treatment of melanoma derives from its
demonstrated activation of the immune system through effects on Toll-like
receptor 9 and signaling through increases in the nuclear factor NfKB,
leading to increases in tumor-infiltrating lymphocytes, specific anti-tumor
cytotoxic lymphocytes, and expression of MHC Class 1 and 2 cell-surface
molecules. Evaluation of thymalfasin's utility in melanoma animal models
has confirmed effective anti-tumor activity.
ZADAXIN is currently approved in more than 30 countries worldwide to treat
a variety of indications. In clinical studies, more than 4,000 patients
being treated with vaccines or infected with viral hepatitis B or hepatitis
C, primary immunodeficiency diseases, or various cancers have been treated
with ZADAXIN with virtually no drug-related side effects.
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® (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 clinical 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™ 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™ in China and Vietnam, for which it will seek
regulatory approval. For additional information, please visit
sigma-tau is a leading, international, pharmaceutical group that invests in
the research, development and marketing of innovative and effective
treatments to improve patient well-being and quality of life. sigma-tau has
its headquarters in Pomezia (Rome, Italy). A total of 13 NCEs and 12 known
molecular entities in 33 different indications are at various stages of
development. Among them, several are aimed at rare diseases. Therapeutic
areas in which the company's research and development are focused include
metabolism, neurology, cardiovascular, oncology and immunology. sigma-tau
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
and our partner's ability to conclude the clinical study described in this
press release and demonstrate a meaningful therapeutic effect for the
indicated usage without significant adverse affects in the patient
population. 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.