SOURCE: SciClone Pharmaceuticals, Inc.

September 15, 2006 06:30 ET

SciClone's SCV-07 Demonstrates Oral Bioavailability

SAN MATEO, CA -- (MARKET WIRE) -- September 15, 2006 -- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today reported phase 1 data indicating that SCV-07 taken orally was safe and led to circulating plasma concentrations similar to those obtained in previous phase 1 studies using a subcutaneous injection of SCV-07. Importantly, SCV-07 taken orally resulted in only 10% plasma level variability between all volunteers in this study, demonstrating highly predictable plasma concentrations after oral dosing of this drug.

"We are pleased by these data demonstrating SCV-07's oral availability, highly predictable plasma concentrations, and minimal variability among volunteers," commented Cynthia Tuthill, Ph.D., Chief Scientific Officer and Senior Vice President of Scientific Affairs at SciClone Pharmaceuticals, Inc. "These results provide us with a solid platform from which to compare different dosing regimes in future human studies, and to evaluate alternate indications in our ongoing animal model studies."

This phase 1 pilot study was designed to evaluate the oral availability of SCV-07 in healthy volunteers. A total of 24 volunteers were randomized into one of three groups receiving SCV-07 in an oral tablet, subcutaneous injection, or sublingual liquid dose at the beginning of each week for a three week period. During the day after dosing, blood levels of SCV-07 were measured for each volunteer. In overall results, SCV-07 showed sufficient oral availability versus subcutaneous injection. SCV-07 did not show sublingual availability.

About SCV-07

SCV-07 is a synthetic dipeptide that has demonstrated immunomodulatory activity by increasing T-cell differentiation and function, biological processes that are necessary for the body to fight off infection. SCV-07 specifically stimulates the immune system through its effects on T-helper 1 cells, which are essential for clearance of viral infections; and SciClone has additional recent data that demonstrate an apparent involvement with Toll-like Receptors (TLR's) of the innate immune system which could be involved in its mechanism of action. SciClone acquired exclusive worldwide rights, outside of Russia, to SCV-07 from Verta, Ltd., a biotechnology company located in St. Petersburg, Russia.

About SciClone

SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN is currently being evaluated in late-stage clinical trials for the treatment of malignant melanoma and hepatitis C. ZADAXIN is approved for sale in select markets internationally, most notably in China where SciClone has an established sales and marketing operation. SciClone's strategy is to leverage its advantage in China by in-licensing or acquiring the marketing rights to other products, such as the DC Bead, to broaden its portfolio in this rapidly growing pharmaceutical market. SciClone's other drug development candidate is SCV-07, currently in early clinical development in the U.S. for the treatment of viral and other infectious diseases. For more information about SciClone, visit www.sciclone.com.

The information in this press release contains forward-looking statements including our expectations and beliefs regarding progress and results of our 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. 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 the progress of ongoing and proposed trials and studies for SCV-07, unexpected adverse results to patients, future actions by the U.S. Food and Drug Administration or equivalent regulatory authorities in China and Europe and the fact that experimental data and clinical results derived from pre-clinical studies or from studies with a limited group of patients may not be predictive of the results of larger studies, as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission.

Contact Information

  • Corporate Contact:
    Richard Waldron
    Chief Financial Officer
    SciClone Pharmaceuticals, Inc.
    650-358-3437