SCICLONE'S SCV-07 THERAPY YIELDS GOOD RESULTS FOR TB.
In phase 2 clinical trials, 80% (35/44) of tuberculosis patients undergoing standard anti-TB chemotherapy were no longer contagious (as measured by negative sputum cultures) 3 months after also receiving a five-day regimen of parenteral SCV-07 therapy compared to 37% (10/27) of 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.
Results from the phase 2 clinical trials were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) by Alexander Kolobov, one of the inventors of SCV-07 and a founder of Verta Ltd., a biotechnology company in St. Petersburg, Russia. Verta conducted the 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 other compounds of a new class of immunomodulators from Verta.
Alfred Rudolph, M.D., SciClone's COO, commented, "We are pleased that SCV-07 has shown important potential benefits in treating tuberculosis patients by reducing the time their sputum is dangerous to others. This could open the door to pursuing the use of SCV-07 orally as a therapeutic for outpatient therapy of tuberculosis, or for the costly and difficult treatment of multi-drug resistant tuberculosis."
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.
These phase 2 clinical trials were funded by a grant awarded jointly to SciClone and Verta by the U.S. Civilian Research and Development Foundation's (CRDF) Next Steps to Market Program. The CRDF is a private, non-profit organization authorized by the U.S. Congress and established by the National Science Foundation in 1995. The CRDF supports scientific and technical collaboration between the United States and the countries of the former Soviet Union through grants, technical resources, and training. The foundation also promotes the transition of weapons scientists to civilian work to help reduce the global spread of weapons of mass destruction. The CRDF is based in Arlington, Virginia, with offices in Moscow and Kiev.
The World Health Organization (WHO) estimates that tuberculosis kills 2 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.
SciClone Pharmaceuticals is a biopharmaceutical company and its lead product ZADAXIN is in two phase 3 hepatitis C clinical trials in the U.S., a phase 3 hepatitis B clinical trial in Japan, a phase 2 malignant melanoma clinical trial in Europe, and two phase 2 liver cancer clinical trials in the U.S.
ZADAXIN has been approved for sale by the ministries of health in 29 countries and is marketed in China and selected other countries outside the U.S. ZADAXIN has been administered to more than 10,000 patients in both clinical and commercial use, alone and in combination with anti-viral and anti-cancer drugs, without producing any ZADAXIN related significant side effects or toxicities.
SciClone's strategic goal is to become a principal worldwide provider of Immune System Enhancers (ISEs) both as monotherapies and as critical components of combination drug therapies for infectious diseases and cancer. SciClone's other drug development opportunities in addition to SCV-07 include products to address the protein-based disorder that causes cystic fibrosis.
For more information, call 650/358-3437.
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|Date:||Nov 1, 2002|
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