SciClone Initiates Phase II Trial of SCV-07 for Hepatitis C

On June 27, SciClone Pharmaceuticals announced that it recently began a new Phase II clinical trial to evaluate the activity of its immunomodulatory peptide SCV-07 (also known as gamma-D-glutamyl-L-tryptophan) in patients with hepatitis C virus (HCV) infection. The company is testing the agent as a sole agent, or monotherapy, for treatment of hepatitis C.

Below is an excerpt from the SciClone press release describing the new trial:

SciClone Initiates Phase 2 Clinical Trial Using SCV-07 to Treat Hepatitis C Patients
SAN MATEO, CA -- June 27, 2007 -- (Marketwire) -- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced it has initiated a proof-of-concept phase 2 clinical trial using its proprietary compound SCV-07 as a sole agent to treat patients infected with the hepatitis C virus (HCV). The trial is designed to evaluate the therapeutic effect of SCV-07 on patients with HCV.

"SCV-07 has shown broad applicability in viral diseases, and we are eager to determine the therapeutic benefit of this compound for patients with HCV," said Friedhelm Blobel, PhD, President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "The objective of this trial is to demonstrate SCV-07's effect on hepatitis C viral load as well as on other measures of immune response, and we expect to report data in the first quarter of 2008. If we are able to determine that SCV-07 stimulates the immune system in a method similar to that of interferon alpha, but without side effects, this could be a significant treatment advance for patients suffering from HCV."

The randomized, placebo-controlled trial plans to enroll 30 patients infected with the difficult to treat genotype 1 strain of the HCV virus who previously responded to treatment with interferon alpha and ribavirin, but subsequently relapsed. Patients will be randomized into three cohorts of escalating doses, and will receive daily subcutaneous injections of SCV-07 or placebo. After completing seven days of therapy, all patients will be monitored for 14 days. The primary endpoint of the trial will be a single-log reduction in the hepatitis C viral load.

About SCV-07

SciClone's proprietary drug candidate SCV-07 (gamma-D-glutamyl-L-tryptophan) is a synthetic peptide with proven immune stimulating effects. SCV-07 has shown efficacy in treating various viral and bacterial infections. SCV-07 specifically stimulates the immune system through its effects on T-helper 1 cells, which are essential for clearance of viral infections. In June 2007, SciClone reported that SCV-07 also inhibits melanoma tumor growth, a cancer know to be sensitive to immune modulation, in an animal model study. Additional preclinical studies with SCV-07 are ongoing.

06/29/07

Source
SciClone Pharmaceuticals. SciClone Initiates Phase 2 Clinical Trial Using SCV-07 to Treat Hepatitis C Patients. Press release. June 25, 2007.