SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN)
today announced that its proprietary immunomodulatory compound SCV-07 was
effective in preclinical studies, significantly reducing lesions in a model
of human papillomavirus (HPV) and increasing survival in a model of Lassa
fever.
These data were presented yesterday at the International Union of
Microbiological Societies (IUMS) conference in San Francisco, California.
The HPV model study was conducted by Neil D. Christensen, Ph.D., Associate
Professor of Pathology, and Microbiology and Immunology at Pennsylvania
State University. The Lassa fever model study was conducted in the
laboratory of Dr. C.J. Peters, Professor, Department of Pathology,
University of Texas Medical Branch at Galveston.
"These data underscore the broad applicability of SCV-07, as they
demonstrate activity in two dramatically different models of viral
infection," said Cynthia Tuthill, Ph.D., Vice President of Scientific
Affairs, SciClone Pharmaceuticals, Inc. "We look forward to initiating
phase 1 clinical studies of SCV-07 in healthy volunteers later this year.
We anticipate proceeding to a phase 2 study in a viral or infectious
disease indication in 2006."
In the HPV model study, animals treated with SCV-07 showed a marked
reduction in papilloma size and volume of both treated and untreated
papillomas, indicating that subcutaneously administered SCV-07 works
systemically to treat all papillomas occurring on the animal. Untreated
animals did not experience reduction in papilloma size or volume. HPV is
one of the most common sexually-transmitted infections worldwide and can
cause genital warts. Certain strains of the virus can lead to cervical
cancer, which affects approximately 50,000 women annually in the United
States.
In a model of Lassa fever, SCV-07 decreased the severity of the disease and
significantly increased the survival of the animals, compared to animals in
the untreated control group. Occasional epidemics of Lassa fever in Africa
have had human fatality rates as high as 50%. The Lassa virus is
classified as a category A (highest) biothreat agent by the National
Institute of Allergy and Infectious Diseases (NIAID).
Earlier studies indicate 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
preclinical and clinical trials for SCV-07, and the fact that the
experimental or clinical data described may imply certain actual results in
larger patient populations. 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 preclinical and clinical trials for SCV-07, the
statistical significance of data obtained from SCV-07 preclinical and
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 preclinical studies, future actions of our collaborative
partner, unexpected adverse results to patients, 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.
Corporate contact:
Becky Horner
Investor Relations
SciClone Pharmaceuticals, Inc.
650-358-3437