SAN MATEO, Calif., April 15 /PRNewswire-FirstCall/ -- SciClone
Pharmaceuticals (Nasdaq: SCLN) 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(R), 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 http://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(R) 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
Web Site: http://www.sciclone.com
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