SciClone reports Hep C data
SciClone Pharmaceuticals, from San Mateo, CA, US has reported positive data from a pilot clinical trial in hepatitis C patients who have not responded to previous therapy.
SciClone Pharmaceuticals, from San Mateo, CA, US has reported positive data from a pilot clinical trial in hepatitis C patients who have not responded to previous therapy.
41% of the non-responder patients tested HCV RNA negative and 50% showed a virologic response after 24 weeks of a new triple therapy of Zadaxin in combination with pegylated interferon alpha and ribavirin. By comparison, separate recent studies show that after 24 weeks of double therapy with pegylated interferon alpha plus ribavirin, approximately 30% of hepatitis C non-responder patients tested HCV RNA negative.
Dr Eduardo Martins, vice president of medical affairs of SciClone Pharmaceuticals, commented: 'As we continue to explore ways to further improve therapy options for the nearly half of hepatitis C patients that do not respond to the current standard of care, we are pleased to see Zadaxin used in combination with standard dose pegylated interferon and low dose ribavirin has improved response rates in this patient group without adding toxicity. Building on these positive interim data, we are closely monitoring the progress of this trial and are considering future triple therapy studies. Our primary focus remains our two ongoing US Phase III clinical trials targeting Zadaxin in combination with pegylated interferon alpha to be the first FDA approved therapy to specifically address the needs of non-responders.'
Triple therapy trial
This ongoing open label clinical trial plans to enroll a total of 50 hepatitis C non-responder patients, none of which have responded to prior therapy of at least six months of interferon alpha in combination with ribavirin. During the course of this study, patients will receive 12 months of triple therapy and will be observed for six months after completing therapy to measure sustained response, defined as negative HCV RNA by PCR test measured at week 72. Of the 22 patients who had completed 24 weeks of triple therapy of Zadaxin in combination with pegylated interferon alpha and ribavirin, 41% (9/22) tested negative for HCV RNA by PCR test and 50% (11/22) showed a virologic response to therapy, defined as a 2 log or greater reduction in the level of HCV RNA. Of the 19 patients infected with the difficult to treat HCV genotype 1, 42% (8/19) tested negative for HCV RNA and 58% (11/19) showed a virologic response to therapy. As in all previous Zadaxin studies, the safety profile was excellent without significant Zadaxin related side effects or toxicities.
About Zadaxin
Zadaxin is a pure synthetic preparation of thymosin alpha 1, a substance which circulates in the blood naturally and is instrumental in the body's immune response to fight viral infections and certain cancers. Zadaxin is easily and safely administered just under the skin twice a week. After administration, thymosin alpha 1 circulates at 50 to 100 times its normal level in the body. Zadaxin has been approved for sale by the ministries of health in over 30 countries and is marketed in China and selected other countries outside the US.