07 October 2003 15:03
SciClone Receives U.S. Government Grant to Develop Oral Formulation of SCV-07; Grant Also Funds Additional Phase 2 Tuberculosis Clinical Trials in Russia
/Health/Medical Writers
BIOWIRE2K
SAN MATEO, Calif.--(BUSINESS WIRE)--Oct. 7, 2003--SciClone Pharmaceuticals (Nasdaq:SCLN) today announced that it has
received a grant from the U.S. Government to develop an oral formulation for SCV-07, SciClone's proprietary
compound that enhances the immune system. In previous phase 2 clinical trials, SCV-07 formulated as an injectable
product demonstrated the capability to significantly increase the rate at which treated tuberculosis (TB) patients
become noncontagious, one of the main goals in treating TB.
SciClone received an $840,000 grant from the Initiatives for Proliferation Prevention, a program offered by the U.S.
Department of Energy to support cooperative scientific developments in the former Soviet Union. SciClone's
collaborator, Verta Ltd., a biotechnology company in St. Petersburg, Russia, will develop an oral formulation for SCV-07
and conduct phase 2 TB clinical trials in Russia, where the TB mortality rate is among the highest in Europe. SciClone
has exclusive worldwide rights outside of Russia to SCV-07 and to other compounds of a new class of immunomodulators
acquired from Verta.
In SCV-07's previous phase 2 clinical trials, 80% (35/44) of TB patients receiving a five-day regimen of an
injectable form of SCV-07 in combination with the standard anti-TB chemotherapy, were no longer contagious (as measured
by negative sputum cultures) three months after therapy began. This compares to a rate of 37% (10/27) in patients whose
anti-TB therapy did not include SCV-07. In addition, all of the patients receiving SCV-07 reported an improvement in
symptoms, including fever and cough, and there was a significant decrease in the number of patients with lung damage.
SCV-07 did not lead to additional adverse events in any of the patients.
"In previous studies, an injectable form of SCV-07 demonstrated significant potential benefits in treating
tuberculosis patients. The development of an oral formulation is the logical next step as this will facilitate the
administration of therapy to tuberculosis patients worldwide and will enhance compliance," commented Cynthia
Tuthill, Ph.D., vice president of scientific affairs at SciClone Pharmaceuticals and the principle investigator for the
grant. "SCV-07 has the potential to reduce the incidence of multi-drug resistant tuberculosis in addition to
potentially treating other diseases such as viral hepatitis C that also require immune system enhancement."
About SCV-07
SCV-07 has shown the capability to stimulate the immune system in a manner similar to SciClone's lead product
ZADAXIN, and SCV-07 may have a significant additional benefit of being orally available. Both ZADAXIN and SCV-07 promote
differentiation of T cells into the T helper 1 (Th1) subset. Studies have shown that Th1 cells are fundamental to
fighting infectious diseases, including TB, viral diseases and certain cancers.
Studies using the injectable form of SCV-07 were funded by the U.S. Civilian Research and Development Foundation
(CRDF), which continues to support the development of this drug.
About Tuberculosis
The World Health Organization (WHO) estimates that tuberculosis kills two million people each year, and is the most
common infectious disease in the world today. It is estimated that between 2000 and 2020, nearly one billion people will
be newly infected, 200 million people will get sick and 35 million people will die from TB. Multidrug-resistant TB is
rising at alarming rates in some countries, particularly those of the former Soviet Union.
About IPP
Initiatives for Proliferation Prevention (IPP) is a nonproliferation program of the National Nuclear Security
Administration at the U.S. Department of Energy. The IPP mission is to enhance U.S. national security by engaging
biodefense scientists and engineers in the former Soviet Union (FSU) in peaceful and sustainable commercial pursuits.
Through cooperative projects involving FSU scientists, U.S. national laboratories, and U.S. industry, IPP identifies
non-military, commercial applications for former Soviet institute technologies. These unique partnerships provide new
resources and markets for U.S. companies, while establishing important private sector linkages for FSU scientists and
engineers.
--30--LO/sf* CONTACT: SciClone Pharmaceuticals Richard A. Waldron, 650-358-3437 (CFO)
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat
life-threatening diseases. Its lead product ZADAXIN is in several late-stage clinical trials, including two phase 3
hepatitis C clinical trials in the U.S., a recently completed phase 3 hepatitis B clinical trial in Japan, a phase 2
malignant melanoma clinical trial in Europe, and two phase 2 liver cancer trials in the U.S. In addition to ZADAXIN,
SciClone's drug development opportunities include SCV-07, a potentially orally available therapy to treat viral and
infectious diseases, and products to address the protein-based disorder that causes cystic fibrosis. Additional
information is available at www.sciclone.com.
This press release may contain forward-looking statements because the experimental or clinical data described may
imply certain actual results in larger patient populations. Experimental data and clinical results derived from studies
with a limited group of patients may not be predictive of the results of larger studies and, therefore, such
experimental or clinical data is not necessarily predictive of efficacy or safety or the results of larger studies and
clinical trials.
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