Cingles Info

Monday April 15, 9:01 am Eastern Time
Press Release
SOURCE: SciClone Pharmaceuticals
SciClone Begins ZADAXIN(R) U.S Phase 3 Hepatitis C Clinical Trials
First Patients Enrolled and Receiving Treatment
SAN MATEO, Calif., April 15 /PRNewswire-FirstCall/ -- SciClone
Pharmaceuticals (Nasdaq: SCLN - news) today announced the first patients in
its ZADAXIN U.S. phase 3 hepatitis C clinical trials have been enrolled and
are receiving treatment.
``The injection of the first patients in our U.S. phase 3 clinical trials
represents the end of years of preparation and the beginning of a new era at
SciClone,'' said Donald R. Sellers, SciClone's President and CEO. ``Everyone
at SciClone is proud of this accomplishment. Our ZADAXIN U.S. phase 3 trials
are designed to demonstrate ZADAXIN contributing a safe, clinically
significant benefit in the treatment of hepatitis C. Even more than our
international successes, these clinical trials provide our shareholders and
the medical community with a clear measurement of our company.'' SciClone
plans to complete patient enrollment and have all patients begin treatment
before the end of 2002.
SciClone's U.S. phase 3 hepatitis C clinical trials include only patients
who have not responded to previous therapy with either interferon or
interferon plus ribavirin. The clinical trials consist of two 500-patient
studies. The clinical trials are multi-centered with 20 major hepatology
medical centers throughout the U.S. participating in each study. ZADAXIN is
being administered in combination with Pegasys®, F. Hoffmann LaRoche's brand
of pegylated alpha interferon to half of the patients while the other half
receives a placebo plus Pegasys. Pegasys is provided by Roche without cost
to SciClone. These studies are randomized, double-blinded, and placebo-
controlled. Patients will be treated for 12 months and then followed for a
6-month observation period. The end points of the study are elimination of
hepatitis C virus and histological improvement, both measured at the end of
observation. The trial design is consistent with the U.S. FDA standard for
demonstrating sustained response and is ideal for ZADAXIN's mechanism of
action.
The ZADAXIN plus Pegasys combination therapy clinical trials are designed to
show a significant sustained response in non-responder patients, the most
difficult to treat segment of the hepatitis C patient population. Current
therapy of year-long treatment with pegylated alpha interferon and ribavirin
is effective in only about 50% of all hepatitis C patients. The
effectiveness of current therapy is highly dependent on the strain, or
genotype, of the infecting virus and the viral load, or level of virus
present in the patient. For genotype 1 patients with a high viral load,
which characterizes about half of the 4 million hepatitis C patients in the
U.S., current therapy is effective in only about 30% of the cases. Patients
that fail to respond to therapy, the non-responders, seldom respond to a
second 12-month regimen of treatment. For example, the success rate for
re-treating non-responders with a second year of alpha interferon plus
ribavirin therapy is only approximately 8 percent. SciClone estimates that
there will be 500,000 non-responders to existing current therapy in the U.S.
by 2005.
Hepatitis C is one of the most serious viral infections with complications
such as cirrhosis, liver failure and liver cancer. Deaths related to
hepatitis C virus in the U.S. are expected to triple by 2010, exceeding the
estimated deaths caused by HIV (the virus which causes AIDS). There is no
vaccine for hepatitis C.
ZADAXIN has been administered without side effects to over 10,000 patients
and is approved for sale in 26 countries, principally for the treatment of
hepatitis B and hepatitis C, and certain cancers. ZADAXIN, an immune system
enhancer (ISE), is a synthetic preparation of a natural peptide, thymosin
alpha 1, which among other positive actions, enhances the body's Th1 immune
response to serious viral infections and certain cancers.
SciClone develops and commercializes pharmaceutical and biological
therapeutic compounds that are acquired or in-licensed at the stage of late
pre-clinical or early clinical development. SciClone's strategic goal, based
on the broad therapeutic potential of its lead drug ZADAXIN, is to become
the preeminent worldwide provider of immune system enhancers as
monotherapies and as critical components of combination drug therapies for
infectious diseases and cancer. Other drugs in SciClone's pipeline are
intended to protect and expand this franchise, and to address the
protein-based disorder that causes cystic fibrosis.
Press releases and corporate information from SciClone are available on the
Internet at www.sciclone.com or by calling the company's Investor Relations
Department at 800-724-2566. SciClone's Common Stock is listed on The Nasdaq
National Market® under the symbol SCLN.
The information in this press release contains forward-looking statements
including the timing of completion of patient enrollment and commencement of
treatment for our U.S. phase 3 hepatitis C clinical trials. Words such as
``expects,'' ``plans,'' ``believe,'' ``may,'' ``will,'' ``anticipated,''
``intended'' and variations of these words or similar expressions are
intended to identify forward-looking statements. In addition, any statements
that refer to expectations, projections or other characterizations of future
events or circumstances, including any underlying assumptions, are
forward-looking statements. These statements are not guarantees of future
performance and are subject to risks, uncertainties and assumptions that are
difficult to predict. Therefore, our actual results could differ materially
and adversely from those expressed in any forward-looking statements as a
result of various factors, including our ability to enroll a sufficient
number of eligible patients to yield statistically significant results, the
speed with which patients are enrolled in the hepatitis C clinical trials
and maintenance of the sufficiency and eligibility of the enrolled patient
population, as well as other risks and uncertainties described in SciClone's
filings with the Securities and Exchange Commission, including our Annual
Report on Form 10-K for the fiscal year ended December 31, 2001 and
quarterly report on Form 10-Q for the quarterly period ended September 30,
2001.
SOURCE: SciClone Pharmaceuticals