FOSTER CITY, CA and ROME--(Marketwire - February 08, 2010) - SciClone Pharmaceuticals, Inc.
(NASDAQ: SCLN) and its partner Sigma-Tau S.p.A., announced additional
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
statistically significant (p value=0.04) increase in the percentage of
subjects who seroconverted, also when evaluated 42 days after vaccination,
compared to those who received the H1N1 vaccine alone. In addition, the
improvement in titers seen in ZADAXIN-treated patients was maintained at
this later timepoint.
"The seroconversion results that we have seen to date in this study are
very encouraging and continue to demonstrate the value that ZADAXIN may
have in offering the public a more powerful vaccine regimen against the
H1N1 virus," said Friedhelm Blobel, Ph.D., SciClone's president and chief
executive officer. "It is our hope that ZADAXIN will ultimately provide the
enhancement benefits to H1N1 vaccines for patients with compromised or
weakened immune systems. If this study continues to show positive data, we
may also explore the potential of ZADAXIN to improve the response to
vaccines with other flu or virus strains."
Findings showed that, when measured 42 days following vaccination, 93% of
patients in the low-dose ZADAXIN arm and 94% of patients in the high-dose
ZADAXIN arm achieved seroconversion, compared to only 77% of patients in
the vaccine-only arm of the study. This increased seroconversion with
ZADAXIN compares favorably with that seen at 21 days following vaccination,
which the companies reported in January 2010 as being 89% and 88% in the
two ZADAXIN groups, compared to only 56% in patients treated with the
vaccine alone, which was a highly statistically significant increase (p
value < 0.01). A higher seroconversion rate is indicative of the robustness
of the immune response and may lead to more durable protection.
Seroconversion -- a significant rise in specific antibody titers against
H1N1 influenza -- is defined as a four fold or greater change in titers
The randomized, three-arm open label study is designed to evaluate efficacy
based on the proportion of patients achieving seroconversion. The ongoing
study, which has a planned duration of six months, is being conducted in
patients with end-stage renal disease who are on chronic dialysis. One
cohort of patients received the H1N1 vaccine only. The other groups
received thymalfasin at either a low dose (3.2 mg) or a high dose (6.4 mg).
Thymalfasin was given twice, the first injection seven days prior to
vaccination and the second on the day of vaccination with Focetria. All
patients who did not achieve an antibody titer of at least 1:40 on day 21
received a second H1N1 vaccination on that day. Dosing regimens were based
on preclinical results obtained in ferret and mouse models conducted in
Europe and the U.S. 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.
"To witness seroconversion rates in the ZADAXIN treatment arms in the range
of 93-94% at 42 days compared to just 77% with vaccine alone is very
promising, especially in an immunocompromised population of patients on
chronic dialysis," said Professor Trevor Jones, group R&D director,
Sigma-Tau. "We are pleased with the ongoing progress of this study and the
positive data that it continues to produce."
The Company will announce further data on the study after all patients have
reached 184 days post vaccination and final topline results are available.
ZADAXIN has an excellent safety profile, with a long track record of
patient use. Approximately 100,000 patients worldwide have used ZADAXIN in
both commercial and clinical 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.
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 website: www.sigma-tau.it
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