>>SciClone's ZADAXIN(R) is Able to Increase Anti-Tumor Effects, While Markedly Reducing the Toxicity of Chemotherapy, in Treating Melanoma, Colorectal Cancer, and NSCLC
SAN MATEO, Calif., Feb 20, 2001 /PRNewswire via COMTEX/ -- SciClone Pharmaceuticals (Nasdaq: SCLN chart, msgs) today announced at the Roth Capital Partners 13th Annual Growth Stock Conference that a review published in the peer-reviewed journal International Journal of Immunopharmacology (Volume 22, pp. 1067-1076) discusses that ZADAXIN(R), SciClone's immune system enhancer (ISE), is able to potentiate the action of cytokines (interferon and interleukin-2) and also reduce the hematological toxicity of cytotoxic drug therapy (cyclophosphamide, 5-fluorouracil, dacarbazine, or ifosfamide based regimens).
The results, published by Enrico Garaci, M.D. and his colleagues at the Department of Experimental Medicine at the University of Rome, provide clinicians and researchers with new insight into the effective use of combination chemo-immunotherapy in the treatment of a variety of common and deadly tumor types. One of the key discoveries of their studies is that thymosin alpha 1, ZADAXIN treatment works best when it is provided following chemotherapy but before cytokine treatment. "This schedule of treatment seems the most efficient in that it allows each agent to exert its specific function through a metabolic pathway on which the successive agent may properly intervene," stated Dr. Garaci.
These studies have also demonstrated the mechanism of action of ZADAXIN and its role as an immune system enhancer (ISE). Triple therapy with ZADAXIN induced the greatest immune stimulation, restoring splenocytes expressing CD3, CD4 and CD8 and also significantly increasing lymphocytes expressing IL-2 receptors (the Th1 subset of CD4 cells). Triple therapy also significantly increased NK (natural killer) and CTL (cytotoxic lymphocyte) cell counts, suggesting that the anti-tumor action was primarily mediated by the host immune response. Another important mechanism of immune stimulation was via the induction of class I MHC molecules on tumor cells, which leads to the recognition and potential cytotoxic destruction by CD8 cells.
In a non-small cell lung cancer (NSCLC) study, combination therapy with ifosfamide, ZADAXIN, and low dose IFN induced 33% major responses and 33% minor responses (in 58% stage IV and 33% stage IIIb patients), whereas patients treated with ifosfamide alone showed a response rate of only 10%. Toxicity was also drastically reduced in patients treated with the triple combination therapy.
ZADAXIN is currently in phase 2 cancer trials worldwide including a malignant melanoma (skin cancer) trial in Australia and a hepatocellular carcinoma (liver cancer) program in the United States. "This report represents another step forward in the understanding of ZADAXIN's effects in cancer patients," said Alfred R. Rudolph, MD, SciClone's Chief Operating Officer.
ZADAXIN has been approved for sale in 21 countries, principally for the treatment of hepatitis B and hepatitis C and as a vaccine adjuvant for patients with weakened immune systems. ZADAXIN is currently in a phase 3 program in the U.S. in combination with Pegasys(R) (pegylated interferon alfa-2a) for the treatment of hepatitis C, and in a phase 2 program in combination with lamivudine for the treatment of hepatitis B. In Europe, a pivotal phase 3 ZADAXIN hepatitis C program will complement the Company's U.S. hepatitis C program. A phase 3 ZADAXIN hepatitis B study is ongoing in Japan as well as a phase 2 trial in hepatitis C. ZADAXIN has been administered to over 3,000 subjects in over 70 clinical trials and an estimated 7,000 patients commercially with virtually no serious drug related side effects or toxicities.<<
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Having bought back my calls on recent weakness, glad to see anything that helps.
Cheers, Tuck |
