Puff; hot biotech: SCLN (index #1) + 326% since listed on Index/details:
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yesterday's news:
Wednesday March 1, 10:00 am Eastern Time
Company Press Release
SOURCE: SciClone Pharmaceuticals, Inc.
New Study Shows ZADAXIN's Dual Role in Immune Recognition of and Response To Cancer and Infection
Mechanism of Action Study Published in European Journal of Immunology
SAN MATEO, Calif., March 1 /PRNewswire/ -- SciClone Pharmaceuticals (Nasdaq: SCLN - news) announced today that a study published in the peer-reviewed European Journal of Immunology (March 2000, Volume 30, Issue 3) shows that ZADAXIN© (thymosin alpha 1) directly increases the immune system's ability to recognize and target cancerous and virally infected cells among healthy cells.
This new study complements a previous mechanism of action study, published in the International Journal of Immunopharmacology (Vol. 21), in which ZADAXIN was shown to enhance the maturation of undifferentiated stem cells into disease-fighting T-cells and to enhance the production of cell messengers that coordinate the complex immune response to disease.
In the currently published study, authored by researchers in Italy and at the U.S. National Institutes of Health (NIH) and National Cancer Institute (NCI), ZADAXIN promoted the production of major histocompatibility complex (MHC) class-1 molecules at the level of gene expression. MHC molecules are the key component of the immune system's method of ``tagging' cells as either healthy or diseased. The effects were seen in multiple mouse and human cell lines as models for cancer and infectious diseases.
According to the article, whose lead author is Cartesio Favalli, Professor of Experimental Medicine and Biochemical Sciences at the University of Rome, ``MHC class-1 downregulation has been shown in many tumors and is considered an important factor in limiting immunotherapy of cancer. Thymosin alpha 1, by inducing MHC class-1 expression, could make tumor cells 'visible' to T lymphocytes and therefore less prone to escape from immune surveillance.'
``This finding may further contribute to explaining the activity of this peptide which, in view of our results, is not only exerted at the immune effector level but also at the target cell level,' concluded Professor Favalli in the published article.
``We now have the most complete picture to date of ZADAXIN's role in the immune system,' said Alfred R. Rudolph, M.D., SciClone's Chief Operating Officer. ``ZADAXIN not only promotes the maturation and differentiation of stem cells into disease-fighting T-cells and other immune weapons, but also makes the diseased cells themselves more visible targets for these weapons.'
``We know ZADAXIN works in hepatitis and cancers. Now, the further understanding of its mechanism of action points to new therapeutic targets where MHC downregulation plays a key role in the disease process,' said Donald R. Sellers, SciClone's President and Chief Executive Officer.
ZADAXIN currently is approved in Italy and 15 countries throughout Asia, Latin America, and the Middle East, principally as a single-agent therapy for hepatitis B, a combination therapy for hepatitis C or as an influenza vaccine adjuvant. SciClone has filed for ZADAXIN marketing approval in 19 additional countries. SciClone expects to start pivotal U.S. Phase 3 studies for hepatitis C during this year.
profile:
SciClone Pharmaceuticals, Inc. is a global biopharmaceutical company that acquires, develops and commercializes specialist-oriented proprietary drugs for treating chronic and life-threatening diseases. Currently, SciClone has two drugs in clinical development, ZADAXIN for hepatitis B, hepatitis C, cancer and immune system disorders, and CPX for cystic fibrosis. The Company also has other drug candidates in pre-clinical development. To date, the Company's principal focus has been the development and commercialization of ZADAXIN and the development of CPX. The Company's ZADAXIN is approved for marketing in 13 countries including Argentina, Cambodia, Italy, Kuwait, Mexico, Myanmar, Pakistan, the People's Republic of China, Peru, the Philippines, Singapore, Venezuela and Vietnam.
Financial Summary
SciClone is a global biopharmaceutical company that acquires, develops and commercializes specialist-oriented drugs for treating chronic and life-threatening diseases. For the nine months ended 9/99, revenues totalled $6.4 million, up from $2.5 million. Net loss applicable to Common decreased 67% to $4.9 million. Results reflect increased sales of ZADAXIN due to greater distribution in China, partially offset by increased payroll and advertising expenses.
Recent Earnings Announcement
For the 3 months ended 12/31/1999, revenues were 2,999; after tax earnings were -535. (Preliminary; reported in thousands of dollars.)
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