SOURCE: SciClone Pharmaceuticals, Inc.

June 23, 2005 06:30 ET

SciClone Files IND Application for SCV-07

SAN MATEO, CA -- (MARKET WIRE) -- June 23, 2005 -- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for SCV-07, a synthetic dipeptide that has demonstrated activity against a broad range of viral and infectious diseases. Pending FDA review and clearance, SciClone expects to initiate a phase 1 clinical trial in healthy volunteers during the second half of 2005.

"Filing the IND for SCV-07 is an important milestone for us as we broaden our product pipeline beyond our lead drug candidate ZADAXIN," commented Ira D. Lawrence, M.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "We believe that we will be able to move quickly through the phase 1 trial and begin dose-ranging, disease-specific phase 2 clinical trials in 2006."

Earlier studies have indicated that SCV-07 stimulates the body's immune response by promoting T-cell differentiation into T helper 1 (Th1) cells, a critical process in the body's fight against infection. SciClone acquired the 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 two phase 3 hepatitis C clinical trials in the United States and one phase 3 hepatitis C trial in Europe. ZADAXIN is also being evaluated in other late-stage clinical trials for the treatment of hepatitis B and certain cancers. The company's other drug development candidate is SCV-07, which is being evaluated for the treatment of viral and 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 the progress of clinical trials for SCV-07. 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 clinical trials for SCV-07, the statistical significance of data obtained from SCV-07 clinical trials, enrollment in clinical trials for SCV-07, competition with other studies for the enrollment of patients meeting a particular patient profile, maintenance of the sufficiency and eligibility of the enrolled patient population, unanticipated delays or additional expenses incurred during SCV-07 pre-clinical studies, future actions of our collaborative partner and the fact that experimental data and clinical results derived 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:
    Becky Horner
    Investor Relations
    SciClone Pharmaceuticals, Inc.
    650-358-3437