SciClone and Sigma-Tau Complete Enrollment in Phase 3 Triple Therapy Hepatitis C

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SciClone and Sigma-Tau Complete Enrollment in Phase 3 Triple Therapy

Hepati..

Market Wire - 28-Dec-2006

This trial is being conducted by Sigma-Tau in Europe and has enrolled a

total of 553 patients. ZADAXIN is SciClone's brand of a pure synthetic

preparation of thymalfasin, a substance which circulates in the blood

naturally. Because stimulation of Th1 cells is associated with a vigorous

antiviral immune response, thymalfasin's effects on the immune system can

explain its effectiveness in treatment of viral infections in animal models

and previous clinical studies.

Summary

• and its European partner Sigma-Tau S.p.A. today announced that full

patient enrollment is complete for its phase 3 clinical trial evaluating the

use of ZADAXIN® (thymalfasin or thymosin alpha 1) in combination with

pegylated interferon alpha and ribavirin to treat patients infected with the

hepatitis C virus (HCV).

• This trial is being conducted by Sigma-Tau in Europe and has enrolled a

total of 553 patients.

• " We believe that ZADAXIN could increase the therapeutic efficacy of

standard HCV treatment without additional side effects, particularly for

non-responder HCV patients infected with a high viral load of the genotype 1

strain of the virus, " said Friedhelm Blobel, Ph.D., President and Chief

Executive Officer of SciClone Pharmaceuticals, Inc.

• " Having met our 2006 milestones with interim survival data from the phase

2 ZADAXIN melanoma trial announced last week and a regulatory submission in

China for the DC Bead filing announced today, we believe that our

management team continues to execute on our primary strategic objectives of

building a leading pharmaceutical business in China and developing ZADAXIN

for the U.S. and European markets. "

• " In the U.S. and Europe, there are more than seven million people

chronically infected with the hepatitis C virus, and current therapy is

insufficient for close to half of all patients, " added o Camerini,

M.D., Research and Development for Sigma-Tau S.p.A.

• " Patients need new therapeutic alternatives, whether novel agents or

additive compounds like ZADAXIN, which address the large and growing group

of patients who have failed to respond to the current standard of care. "

• The phase 3, multi-center, double-blinded, randomized study enrolled 553

predominately genotype 1 HCV patients who have not responded to previous

treatment with pegylated interferon alpha and ribavirin.

• Patients have been randomized to receive either ZADAXIN or a placebo, and

all patients are receiving pegylated interferon alfa-2a and ribavirin.

http://www.therapeuticsdaily.com/news/summary.cfm?id=1187227 & channelID=31

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