SciClone Initiates U.S. Phase 2 Study of ZADAXIN Plus
Lamivudine For Hepatitis B
PR Newswire - January 27, 2000 10:15
SAN MATEO, Calif., Jan. 27 /PRNewswire/ -- SciClone Pharmaceuticals (Nasdaq: SCLN)
today announced the start of a U.S. Phase 2 hepatitis B study using ZADAXIN, the
Company's host immune system enhancer (h-ISE), in combination with lamivudine, an
FDA-approved nucleoside analogue. The study, conducted at Loyola University of Chicago,
will assess the safety and efficacy of the combination in the treatment of chronic hepatitis B
patients.
Approximately 1.2 million people in the U.S. are chronic carriers of hepatitis B. Lamivudine
currently is used as a single-agent treatment. However, treatment with nucleoside analogues
alone can result in drug-resistant mutations of the hepatitis B virus and discontinuation of
treatment can lead to the resurgence of disease.
"Past studies suggest great promise for the combination of ZADAXIN plus lamivudine," said
David Van Thiel, M.D., Medical Director of the Liver Transplant Program at Loyola University
and lead investigator of the current Phase 2 study. "It is quite possible that multi-drug cocktails
will emerge as the preferred treatment regimen for hepatitis B in the U.S., just as we have seen
with HIV and hepatitis C."
In two previous pilot Phase 2 studies conducted in Asia, the combination of ZADAXIN plus
nucleoside analogues produced durable responses -- as measured by the sustained
seroconversion of hepatitis B e antigen and disappearance of hepatitis B virus DNA -- in a
clinically significant number of patients treated with the combination. Only patients treated with a
combination regimen showed seroconversion. There were no side effect differences between
the single and combination drug regimens.
"We believe that ZADAXIN plus lamivudine could be an ideal combination therapy for hepatitis
B - a combination designed to boost the patient's immune system while suppressing hepatitis B
viral replication," said Alfred R. Rudolph, M.D., SciClone's Chief Operating Officer. "This
combination has the potential to produce a higher sustained response rate than either drug used
alone, with the added safety advantage of limiting lamivudine therapy to only six months."
ZADAXIN currently is approved in Italy and 15 countries throughout Asia, Latin America, and
the Middle East, principally as a single-agent therapy for hepatitis B, a combination therapy for
hepatitis C or as an influenza vaccine adjuvant. SciClone has filed for ZADAXIN marketing
approval in 19 additional countries. SciClone expects to start pivotal U.S. Phase 3 studies for
hepatitis C during this year.
Hepatitis B is a highly infectious liver disease that can lead to liver cancer and death.
Worldwide, there are approximately 350 million long-term carriers of the hepatitis B virus,
including 1.2 million in the United States. These carriers of the hepatitis B virus have a 200-fold
increased chance of developing serious liver disease, including liver cancer, the most common
cancer in the world, and cirrhosis. According to the Centers for Disease Control and
Prevention, over 200,000 Americans contract acute hepatitis B each year.
SciClone Pharmaceuticals is a global biopharmaceutical company that acquires, develops and
commercializes specialist-oriented drugs for treating chronic and life-threatening diseases, such
as hepatitis B, hepatitis C, cystic fibrosis, cancer and immune system disorders. Press releases
and corporate information from SciClone Pharmaceuticals 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 includes certain forward-looking statements concerning the
Company's current expectations regarding future events, including the Company's expectations
regarding the safety and efficacy of ZADAXIN in combination with lamivudine for the treatment
of chronic hepatitis B and the timing of the start of the Company's pivotal U.S. Phase 3 studies
for hepatitis C. Actual events could differ materially from those projected herein. Actual events
or results could differ materially depending upon a number of factors. Investors should consult
the Company's filings with the Securities and Exchange Commission for additional information
on risks and uncertainties relating to these forward-looking statements.
SOURCE SciClone Pharmaceuticals
/CONTACT: Shawn K. Singh, J.D., Chief Business Officer, or 650-358-1451,
or Ruth Koh, Investor Relations, or 650-358-3437, both of SciClone
Pharmaceuticals/
/Web site: sciclone.com
Stock trading at $8 3/4.
Jack |
