SOURCE: SciClone Pharmaceuticals, Inc.

June 05, 2006 06:30 ET

SciClone Announces Presentation of Pre-Clinical Data Showing Oral SCV-07 Efficacy Against Tuberculosis

SAN MATEO, CA -- (MARKET WIRE) -- June 5, 2006 -- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced the presentation of pre-clinical data demonstrating that SCV-07 in an oral formulation retains its immunomodulatory properties and is as effective as the standard injection formulation against tuberculosis (TB) in an animal model study. Alexander Kolobov, Ph.D. of Verta, Ltd. presented these data yesterday at the annual meeting of the Federation of Clinical Immunology Societies (FOCIS) held in San Francisco, CA.

Cynthia Tuthill, Ph.D., Chief Scientific Officer and Senior Vice President of Scientific Affairs at SciClone Pharmaceuticals, Inc., commented, "We are pleased with these data that suggest SCV-07 is orally active, and that the tablet has comparable efficacy to the injection formulation in this animal model of TB. We also have a phase 1 oral comparison clinical study underway to evaluate the oral availability of SCV-07 in healthy human volunteers. Results from this trial are expected in the second half of this year, and, if positive, could substantially broaden the therapeutic potential for SCV-07."

In the TB study designed to evaluate the efficacy of an oral formulation of SCV-07, mice were infected with M. tuberculosis Erdman. Twelve days after infection, all mice were treated with isoniazid and rifampicin, and some were further treated for five days with either oral or intraperitoneally injected SCV-07 at doses ranging from 0.10 to 10 ug/kg. Forty five days later, pathological signs of tuberculosis were evaluated, and both the oral and injected groups demonstrated significant improvement when treated with 1.0 ug/kg of SCV-07, compared to the control group which showed minimal changes.

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 to market 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 information contact:
    Becky Horner
    Investor Relations
    SciClone Pharmaceuticals, Inc.
    650-358-3437