SOURCE: SciClone Pharmaceuticals, Inc.

February 05, 2007 06:30 ET

SciClone Announces Accelerated Clinical Development Plans for SCV-07

Phase 2 Trial to Begin in Second Quarter 2007

SAN MATEO, CA -- (MARKET WIRE) -- February 5, 2007 --SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that based on an extensive review of positive human clinical trial and animal model results, it will initiate a controlled phase 2 dose-ranging clinical trial using its proprietary compound SCV-07 in the second quarter of 2007. In addition, the company is evaluating this compound in a variety of animal models of disease and will report the results of these studies in the third quarter.

"We have evaluated several viable therapeutic directions for SCV-07 since I joined SciClone in June 2006, and after a thorough review of the data, we intend to initiate an active clinical program to maximize the potential of this proprietary compound," said Friedhelm A. Blobel, Ph.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "As we will present today at a conference in Washington, D.C., we have demonstrated proof of concept in human clinical trials at a very low cost to SciClone through our work with Verta Ltd. in Russia. We look forward to conducting our planned phase 2 dose-ranging trial in the United States to accelerate the development of SCV-07 to target serious viral infectious diseases representing significant market potential."

SciClone acquired exclusive worldwide rights, outside of Russia, to SCV-07 from Verta, Ltd., a biotechnology company located in St. Petersburg, Russia. Verta's invention and development of SCV-07 was partially funded through a grant from the U.S. Civilian Research & Development Foundation (CRDF). SciClone assisted Verta in obtaining this grant, and today, Cynthia Tuthill, Ph.D., SciClone's Senior Vice President and Chief Scientific Officer, will present at the "Advancing National Security: Engaging Scientists Globally - Successes and Opportunities" luncheon briefing sponsored by Senators Joseph Biden and Richard Lugar in Washington, D.C. Dr. Tuthill's presentation will address the economic and scientific benefits of the CRDF program as demonstrated by the successful development of SCV-07 in partnership with Verta.

About SCV-07

SCV-07, a proprietary agent with potential ability to fight viral infectious diseases, 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. Recently, SCV-07 was shown to interact with Toll-like Receptors (TLRs) of the innate immune system. Data from a phase 1 clinical trial showed 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.

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. A key part of 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 infectious diseases. For more information about SciClone, visit

The information in this press release contains forward-looking statements including our expectations and beliefs regarding future sales and financial results, and 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. In addition, any statements that refer to expectations, goals, projections or other characterizations of future events or circumstances, including any underlying assumptions, are 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 or failure of ongoing and proposed trials and studies, including without limitation for SCV-07, our actual experience in executing on our objectives, the performance and future actions of our partners, unexpected delays in preparation for enrollment, maintenance of the sufficiency and eligibility of the enrolled patient population, unanticipated delays or additional expenses incurred during our clinical trials, our future cash requirements, delays in analyzing and synthesizing data obtained from clinical trials, 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.