FOSTER CITY, CA--(Marketwire - November 30, 2009) - SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that Rome-based development partner Sigma-Tau,
S.p.A., has initiated a pilot study in Italy to evaluate ZADAXIN's®
(thymalfasin) ability to enhance immune response to the MF59 adjuvanted
H1N1 influenza monovalent vaccine, Focetria™ from Novartis. The study,
being conducted in hemodialysis patients, is now completely enrolled,
having reached full enrollment after two days. Top-line clinical results
are expected by late 2009 or early 2010.
SciClone and Sigma-Tau conducted preclinical studies earlier this year to
demonstrate the potential of ZADAXIN to enhance the immune response to H1N1
pandemic flu vaccines. Preclinical studies including one with ferrets
demonstrated the feasibility of ZADAXIN to fit into the one or two dosing
regimens of such vaccines.
The randomized, three-arm open study is being conducted in approximately
120 patients with end-stage renal disease who are on chronic dialysis. One
cohort of patients will receive the H1N1 vaccine only, while the other two
groups will receive either two low-dose injections of thymalfasin (3.2mg
seven days prior to vaccination and on the day of vaccination), or two
higher dose injections of thymalfasin (6.4mg seven days prior to
vaccination and on the day of vaccination). Dosing regimens are based on
preclinical results obtained in ferret and mouse models conducted in Europe
and U.S. earlier this year.
The primary efficacy endpoint is the proportion of patients who achieve
seroconversion (significant rise in specific antibody titers believed to be
protective). Additionally, patients will be followed for six months to
assess the durability of the protective titers.
"Patients with end-stage renal disease requiring hemodialysis and other
conditions which compromise the immune system, as well as the elderly, can
often have difficulty developing sufficient antibodies to fight off
infectious diseases such as H1N1 influenza. Equally important, many
patients who do achieve protective titers initially are unable to sustain
these for longer periods of time, making them susceptible to infection and
requiring revaccination or booster shots," said Professor Roberto
Gasparini, MD, Department of Health Sciences, Section of Hygiene &
Preventive Medicine, University of Genoa. "We are encouraged by
thymalfasin's ability to increase antibody production in light of the
preclinical studies results, while possibly sustaining this response for
longer periods of time. We hope that this clinical trial will show that
thymalfasin can be a safe and effective tool to help protect vulnerable
patients from the potential life-threatening effects of the H1N1 virus."
"ZADAXIN is currently approved in Italy and more than 10 other countries as
an enhancer for the influenza vaccine in immune-compromised patients," said
Friedhelm Blobel, Ph.D. SciClone's President and Chief Executive Officer.
"We are confident that ZADAXIN's immune-stimulating properties will help
these patients maximize the immunogenic effects of the H1N1 vaccine and
help fight off this pandemic virus."
Previous studies examining the use of ZADAXIN to enhance seasonal influenza
vaccines for hemodialysis patients showed that 65% of patients receiving
ZADAXIN enhancer achieved protective antibody response, versus 24% of those
who received the vaccine alone. A similar study in 330 elderly patients
showed a 70% protective antibody response rate among those receiving
ZADAXIN plus influenza vaccine, versus 35% of those who received the
vaccine alone. ZADAXIN was also shown to decrease the incidence of
influenza in these elderly patients. According to a study published in The
Gerontologist, 19% of patients who received the vaccine alone developed
influenza, while only 6% of those who also received ZADAXIN became
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 the immune response to certain cancers and viral infections. Published
scientific and clinical studies have shown that thymalfasin helps stimulate
and direct the body's immune response to eradicate infectious diseases like
HCV and HBV, as well as certain cancers.
Thymalfasin works by stimulating a number of immune system responses and
also elicits direct antiviral and anti-cancer effects. Within the immune
system, thymalfasin stimulates stem cell differentiation and increases
production of disease-fighting T cells, including CD4, CD8, and natural
killer cells. Simultaneously it slows the breakdown and removal of these T
cells. It also increases production of T-helper cells which allow the
immune system to tag and identify invasive agents. Thymalfasin increases
the production of proteins that stimulate T cell creation while decreasing
production of certain proteins which are counterproductive in the fight
against chronic viral infections. Additionally, thymalfasin helps
dramatically slow down viral replication, allowing the strengthened immune
system to more efficiently destroy virally infected cells.
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 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 and non-clinical studies, more than
4,000 patients with viral hepatitis B and hepatitis C, primary
immunodeficiency diseases, and numerous 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 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 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
ability to conclude the clinical trial 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